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CURRICULUM VITAE for RICHARD A. KRAUSE, M.D.
Office Address: WR-ClinSearch, LLC (dba, Clinsearch) 6035 Shallowford Road, Suite 109 Chattanooga, TN 37421 (423) 698-4584 Chattanooga Endoscopy Center 2341 McCallie Avenue, Plaza Three, Suite 303 Chattanooga, TN 37404
Medical Licensure: State of Tennessee License #10573 1977-Present Board Certificates: Internal Medicine June 1975 Gastroenterology November 1985 Medical Training: Fellowship Gastroenterology Fellowship – St. Vincent Hospital, Affiliate of University of Massachusetts Worcester, Massachusetts – 1976-1977 Gastroenterology Fellowship – Yale University Hospital and Affiliated Hospitals, New Haven, Connecticut – 1975-1976
Residency Senior Assistant, Internal Medicine – Emory University and Affiliated Hospitals, Atlanta, Georgia – 1974-1975
Junior Assistant, Internal Medicine – Emory University and Affiliated Hospitals, Atlanta, Georgia – 1973-1974 Internship Emory University and Affiliated Hospitals – 1972-1973: Grady Memorial Hospital – Atlanta, GA Emory University Hospital – Atlanta, GA Veteran’s Administration Hospital – Atlanta, GA
Medical School: Temple University School of Medicine Philadelphia, Pennsylvania– 1968-1972 Degree: Doctor of Medicine Undergraduate: University of Pennsylvania Moore School of Engineering Philadelphia, Pennsylvania -- 1964-1968 Degree: BS in Electrical Engineering, Honors: Cum Laude, Tau Beta Pi, Eta Kappa Nu, Sigma Tau Work Experience: 2016-Present WR-Clinsearch, LLC, Medical Director 6035 Shallowford Road, Suite 109, Chattanooga, TN 37421 1990-2015 Clinsearch, LLC, Medical Director and Owner 6035 Shallowford Road, Suite 109, Chattanooga, TN 37421
1998-Present Chattanooga Endoscopy Center (formerly Digestive Disorders Endoscopy Ctr) 2341 McCallie Avenue, Plaza Three, Suite 303, Chattanooga, TN 37404 1977-2006 The Center for Digestive Disorders 2341 McCallie Avenue, Plaza Three, Suite. 201, Chattanooga, TN 37404
R. Krause CV Page 1 of 18 06-Feb-2017 2 Articles: Abstract October 2003, Clinical Consensus: The Constipation Crisis in Long-Term Care, Co- Author Abstract May 2000, Specific Criteria to define a Study Population with COPD for Clinical Trials in Acute Exacerbation of Chronic Bronchitis, Co-Author 1999, Prevention of Meal Induced Heartburn: Lansoprazole is Superior to Omeprazole, Co- Author August 1998, A Comparison of 10 & 14 Days of Lansoprazole Triple Therapy For H-Pylori, Co- Author December 1997, Triple Versus Dual Therapy for Eradicating H-Pylori and Preventing Ulcer Recurrence: A Randomized, Double-Blind, Multicenter Study in Different Dosing Regimens, Co- Author March 1997, 10 versus 14 Day Triple Therapy with Lansoprazole (Prevacid), Amoxicillin, and Clarithromycin in the Eradication of Helicobacter Pylori (HP), Co-Author November 1996, Seven-Day Triple Therapy with Lansoprazole, Clarithromycin, and Metronidazole for the Cure of Helicobacter Pylori Infection: A Short Report, Co-Author July 2007, A Randomized, Double-Blind, Placebo-Controlled Study to Assess Efficacy and Safety of 0.5 mg and 1mg Alosetron in Women with Severe Diarrhea- predominant IBS, Co-Author
Lectures/Teaching: 2014 University of Tennessee at Chattanooga, Family Practice 2007 “Ask the Doc” Monthly TV Show Channel 3 News 2006 Family Practice Residents on GI Rotation “Ask the Doc” Monthly TV Show Channel 3 News 2005 What to Do When You Over Estimate Enrollment, Clinical Research Nuts and Bolts Symposium University of Tennessee at Chattanooga, Family Practice Residents on GI Rotation “Ask the Doc” Monthly TV Show Channel 3 News 2004 Family Practice Residents on GI Rotation 2003 Diagnostic Center of Chattanooga Channel 12 Health Matters Renaissance Common Pharmacy Society at Chattanooga Choo-Choo 2001 University of Tennessee, Family Practice Residency Clergy H.O.P.E. (Healthcare’s Ongoing Pastoral Education) Critical Care Nursing Program, Chattanooga Chapter for Nurse Practitioners Diagnostic Center of Chattanooga 2000 University of Tennessee Family Practice Residency Tennessee Association of Occupational Health Nurses Chattanooga Chapter of Medical Assistants Tennessee Osteopathic Medical Association Clergy H.O.P.E. (Healthcare’s Ongoing Pastoral Education) Critical Care Nursing Program
R. Krause CV Page 3 of 18 06-Feb-2017 Memorial Hospital Family Practice Resident Program Tennessee Chapter for Occupational Health Nurses Tennessee Annual Doctor of Osteopath Meeting Chattanooga Chapter for Nurse Practitioners Corporate & Community Health Lectures on GERD, IBS, Esophagitis, Colon Cancer Prevention, etc. 1999 Faculty – Chattanooga Area Critical Care Course Faculty – Annual Tennessee Society of Radiological Technologist Educational Conference Foundation for Ulcerative Colitis/Crohn’s Disease IBS and Heartburn Support Groups, Chattanooga, TN NSAID Induced GI Problems, Chattanooga, TN GI Emergencies, SGNA, Chattanooga, TN Media: 1991-Present Frequent guest on local television and radio stations Chattanooga State Fast Forward Channel 3 – Stomach Hotline Tennessee Valley Authority Colon Cancer Awareness Channel 9 – “This and That” Show Continuing Education (past 10 years): 2016 Advanced Cardiac Life Support Certification Renewal, AMRI: 10 CME credits CITI Good Clinical Practice (ICH Focus) for Investigators Curriculum CITI Human Subjects Research – Investigators’ Refresher Curriculum CITI Health Information Privacy and Security (HIPS) Curriculum Practical Reviews in Gastroenterology, Vol. 33, 3-12; Vol. 34, 1-8: 72 CME credits 2015 Certification in the EASI, SCORAD, IGA, and BSA Dermatological Rating Scales 2013 Practical Reviews in Gastroenterology Vol. 29 & 30: 56 CME credits OSHA/Bloodborne Pathogens Training, Steri-Safe CITI Human Research Curriculum CITI Good Clinical Practice Curriculum Avoiding EHR pitfalls, University of Tennessee College of Medicine ACT, PASAT, MINI, C-SSRS, Placebo-Response: Rater Approval, Clintara 2012 Practical Reviews in Gastroenterology, Vol. 27, 12; Vol. 28, 3-12; Vol. 29, 1-7: 72 CME credits 2011 Practical Reviews in Gastroenterology Vol. 27, 4-9: 28 CME credits 2010 CITI Human Research curriculum CPR & AED, American Heart Association Rave EDC Investigator PI Training, Medidata University Managing Difficult Patients, University of Tennessee Practical Reviews in Gastroenterology: 82 CME credits Clinical Advances in Gastroenterology, Oakstone Medical Publishing: 9 hrs CME
4 Multimedia Reviews in GI, Johns Hopkins Univ. School of Medicine (JHUSOM): 44 CME Practical Reviews in Gastroenterology, JHUSOM: 22 hrs CME 2009 EDC Investigator Training, Medidata University Reducing Malpractice Risk (An Ounce of Prevention), UT Health Science Center GCP, SAE and AE Management , ePharma Solutions Advanced Cardiac Life Support Renewal, Parkridge Medical Center Management of Constipation: Considerations for Clinical Practice, CME Consultants Clinical Advances in Gastroenterology, American College of Gastroenterology OSHA/Bloodborne Pathogens Training, Steri-Safe Emerging Diagnostic & Treatment Strategies for IBS, Am. Coll. of Gastroenterology Weekend with GI Experts, University of Tennessee College of Medicine Diagnostic Evaluation of Dysphagia, Wyeth Freedom from IBD: Keys to Personalized UC Management, University of Kentucky 5-ASA in the Treatment of Ulcerative Colitis: Management & Adherence, AKH Inc. Emerging Issues in Management of IBD, Including UC & Proctitis, CME Conslt. Management of Constipation: Considerations for Clinical Practice, JHUSOM Multimedia Reviews in Gastroenterology, Audio-Digest Found. Gastroenterology CITI: Basic Course-Human Research, CITI: Refresher 2 Course-Human Research 2007 Reviews in Gastroenterology, JHUSOM Good Clinical Practices for Clinical Investigators, Tap Pharmaceuticals Good Clinical Practice and Adverse Experience Reporting, Merck 2006 Gastroenterology Linked to Endoscopy and Hepatology, Mayo College of Medicine Emerging Data in the Management of Hep C, Postgraduate Institute for Medicine Treatment of UC 1 & 2: Natural History, Outcomes, and Prognosis, Expert Insights, University of Wisconsin Medical School General Risk Management Seminar, University of Tennessee College of Medicine Clinical Research Principal Investigator Experience: Studies Conducted in Therapeutic Areas Other than Gastroenterology Cardiovascular
A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of XX and YY Combination Therapy to XX and YY Monotherapy in Subjects with Mixed Dyslipidemia XX to reduce cardiovascular outcomes by reducing triglycerides in diabetic patients A Randomized, Double-Blind, Placebo Controlled, Phase 3 study of XX in the Prevention of CV events among subjects with low levels of ldl-cholesterol and elevated levels of c-reactive protein.
R. Krause CV Page 5 of 18 06-Feb-2017 A randomized, double-blind, multi-center, multifactoral, placebo controlled, parallel group study to evaluate the efficacy and safety of XX and XY and alone in hypertensive patients. A 52-week open-label extension to the randomized, double-blind, multifactoral, placebo-controlled, parallel group study to evaluate efficacy and safety of XX and XY combined and alone in hypertensives A Multicenter, Comparative Study to Evaluate the Safety and Efficacy of XX Versus XY for the Treatment of High Blood Pressure. A Six-month, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Determine the Efficacy and Safety of 300 and 450 mg/day Transdermal Testosterone in Female Patients with Low Ejection Fraction and Symptomatic Heart Failure A Phase 3, Open-Label, Randomized, Long-Term Comparison of the Safety and Tolerability of the XX Plus XY Fixed-Dose Combination vs. XZ Fixed-Dose Combination for Essential Hypertension A Multi-Center, Randomized, Double Blind, Placebo-Controlled, 8-week Study to Evaluate Safety and Efficacy of XX and XY Given as a Fixed-Dose Combination with Stage 1 or 2 Essential Hypertension. Dermatology
A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Multicenter Study of the Safety and Bioequivalence of XX Cream in Subjects with Mild to Moderate Atopic Dermatitis
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of Multiple XX Dose Regimens for Maintaining Treatment Response in Patients with Atopic Dermatitis An Open-Label Study of XX in Patients with Atopic Dermatitis who Participated in Prior XX Trials A Phase 3, Confirmatory Study Investigating the Efficacy and Safety of XX Administered to Adult Patients with Moderate to Severe Atopic Dermatitis. A Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled, Multicenter Study to Evaluate the Safety and Bioequivalence of XX Cream in the Treatment of Mild to Moderate Atopic Dermatitis A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel Design, Study comparing a Generic Topical Gel to XX Topical Gel in the Treatment of Acne Vulgaris. A Double-Blind, Randomized, Parallel-design, Vehicle Controlled, Multicenter Trial Comparing Generic to Innovator Topical Gel and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris. A Double-Blind, Randomized, Parallel-group, Vehicle-controlled, Multicenter Study Comparing XX Generic to Reference Listed Drug in the Treatment of Acne Vulgaris A Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled, Multicenter Study Comparing a Generic XX Cream, to Reference Cream in the Treatment of Acne Vulgaris A Phase 3 Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study Comparing Efficacy, Tolerability and Safety of XX and Vehicle Gel in the Treatment of Acne Vulgaris
6 Endocrinology A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of XX during Metformin Up-titration Compared with Metformin Up-titration Alone in Subjects with Type 2 Diabetes Mellitus
A Randomized, Double-Blind, Phase 3b Proof-of-Concept Study to Evaluate the Efficacy and Safety of XX Vs Placebo in Combination with Metformin in Subjects with Hypertension and Type 2 Diabetes. A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-controlled Study of the Safety and Efficacy of XX w/ Metformin in Type 2 Diabetes Subjects w/ Inadequate Glycemic Control on Metformin Monotherapy A Randomized, Double-Blind, Phase 3b Proof-of-Concept Study to Evaluate the Efficacy and Safety of XX Vs Placebo When Used with Metformin in Subjects with Hypertension and Type 2 Diabetes. A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 2 Study to Evaluate the Safety and Efficacy and Dose Response of 28 Days of Once-Daily Dosing of the Oral Motilin Receptor Agonist XX, in Type 1 and 2 Diabetic Male and Female Subjects with Gastroparesis A Phase 3, Randomized, Double-blind, Active Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of XX Vs to XY in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control A Study to Assess the Efficacy and Tolerability of XX Co-Administered with Insulin in Type 2 Diabetes A Multicenter, Randomized, Double-Blind, Parallel Group, 6-Wk Study to Evaluate Efficacy and Safety of X/Y Combination Tablet Vs XZ in Patients with Type 2 Diabetes Mellitus and Hypercholesterolemia A Multicenter, Randomized, Double-Blind Factorial Study of the Co-Administration of XX and XY in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control A Multicenter Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of XX Monotherapy in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control A Single-Arm, Open-Label, Multicenter Study Evaluating Triglyceride Changes in Subjects with Type 2 Diabetes and Dyslipidemia Following Treatment Conversion from XX to XY with Stable Statin Therapy A Multicenter Double-Blind, Randomized, Active-Controlled, Parallel Group Study to Evaluate the Lipid-Altering Efficacy of XX in Patients With Type 2 Diabetes and Dyslipidemia A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Safety and Efficacy of XX in Type 2 Diabetes Mellitus on Background Glimepiride with or without Metformin
R. Krause CV Page 7 of 18 06-Feb-2017 A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate Safety and Efficacy of XX in Patients with Type 2 Diabetes Mellitus on Background Treatment with Pioglitazone A Randomized, Double-Blind, Placebo and Active Controlled Parallel Group, Multicenter Study to Determine the Efficacy and Safety of XX with Metformin Compared with Metformin Plus Sitagliptin, Metformin Plus Glimepiride, and Metformin Plus Placebo in Type 2 Diabetes Mellitus. A Randomized, Open-Label, Parallel Group, Multicenter Study to Determine the Efficacy and Long Term Safety of XX Compared with Insulin in Subjects With Type 2 Diabetes Mellitus. A Randomized, Double-Blind, Placebo & Active Controlled, Parallel Group, Multicenter Study to Determine Efficacy and Safety of XX with Metformin and Glimepiride Compared with Metformin Plus Glimepiride and Placebo and with Metformin Plus Glimepiride and XY in h Type 2 Diabetes Mellitus. A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of XX During Metformin Up-titration in Type 2 Diabetes Mellitus GYN A Phase 2, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of XX in patients with Endometriosis An 18-Month Double-Blind, Placebo-Controlled, Phase 3 Trial with a 12-Month Interim Analysis of the Effect of XX on Fracture Incidence in Women with Postmenopausal Osteoporosis A Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Oral XX in Patients with Recurrent Herpes Labials A Double Blind, Randomized, Placebo-And Active-Controlled Safety And Efficacy Study Of XX/Conjugated Estrogen Combinations In Postmenopausal Women A phase 2, 16 week Multicenter, Randomized, Double Blind Placebo Controlled, Parallel Group Proof of Concept Study Evaluating the Efficacy and Safety of XX for the treatment of Pain Associated with Endometriosis A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of XX in Subjects with Endometriosis Health / Nutrition Double-Blind, Multi-Center, Randomized, Parallel-Group, 16 Week Study of XX Administered Orally Once-A-Day with or without a Low Calorie Diet Lead in Obese Adults with OLE of 6 Months A 2 Year Study (1Year Weight Loss,1 Year Regain Prevention) to Assess the Safety, Tolerability and Efficacy of XX in Obese Patients A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety, Tolerability, and Efficacy or XX in Obese Patients A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of XX in Obese Patients A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed Dose, Multi-center Study of Weight-Reducing and Prevention of Weight Regain Effects and Safety of XX in Obese Patients A 52-Week, Double-blind, Randomized, Placebo-Controlled, Parallel-group Study to Assess the Safety and Efficacy of XX in Overweight and Obese Patients
8 A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate Long-Term Treatment with XX on MACE and Type 2 Diabetes in Obese Subjects with Cardiovascular Risk Factors Hematology A Multi-center, Randomized, Controlled Study to Investigate the Safety and Tolerability of Intravenous Ferric Carboxymaltose (FCM) vs. Standard Medical Care in Treating Iron Deficiency Anemia A Multi-Center, Randomized, Controlled Study to Investigate the Safety and Tolerability of IV XX vs. standard Medical Care in Treating Iron Deficiency Anemia in Non-Dialysis Dependent Subjects A Multi-center, Randomized, Blinded, Placebo Controlled, Cross-Over Study to Investigate the Safety and Tolerability of Intravenous XX in Patients with Iron Deficiency Anemia Hepatology A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of XX in Subjects with Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of XX in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH) A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to assess Efficacy and Safety of XX for Prevention of Complications in Subjects with Early Decompensated Liver Cirrhosis. A Phase 2 Efficacy and Safety Study of XX for NASH in Adult Subjects with Liver Fibrosis A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of XX for NASH Fibrosis. A Phase 3, Double-Blind, Randomized, Placebo-Controlled Safety & Efficacy Study of XX for NASH A Phase 2, Randomized, Double Blind, Placebo Controlled Clinical Study Investigating the Effects of XX and Atorvastatin Treatment on Lipoprotein Metabolism in Subjects with NASH A Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Phase 2 trial of XX for NASH Musculoskeletal A phase 2a, Randomized, Double-Blinded, Placebo-controlled, Parallel-group Study to Assess the Analgesic Efficacy and Safety of XX in Patients with Fibromyalgia Safety and Tolerability Study Comparing XX given as an Oral Solution to a Single blinded Combination of Oral Tablets plus Oral Solution in Subjects with Fibromyalgia A Three-Month, Open-Label, Safety Trial of XX in Patients with Fibromyalgia A 14-Week, Randomized, Double-Blind, Placebo-Controlled Trial of XX in Patients with Fibromyalgia
R. Krause CV Page 9 of 18 06-Feb-2017 An Extension Study of XX for the Treatment of Fibromyalgia A Phase 3 Pivotal, Multicenter, Double-Blind, Randomized, Placebo-Controlled Monotherapy Study of XX for Treatment of Fibromyalgia
Neurology Studies A Parallel Group, Double-Blind, Randomized, Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of XX Administered Intravenously in Patients With Chronic Migraine A Phase 2, Randomized, Double-Blind, Placebo-controlled Study of XX in Patients with Migraine A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose- Finding Study of XX in the treatment of acute Migraine Double-Blind, Randomized, Placebo controlled, Dose-ranging Trial of XX for Acute Treatment of Migraine A Randomized, Double-Blind Comparison of 5 mg of XX, 15 mg of XY, and Placebo in the Treatment of Patients with Primary Insomnia A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Proof-of- Concept Study to Evaluate the Safety and Efficacy of XX Taken in Combination with XY for the Treatment of Subjects with Chronic Insomnia A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Subjective Response to Treatment With XX in Adult Subjects With Chronic Insomnia by Utilizing an Interactive Voice Response System (IVRS) for Collecting Diary Data
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Outpatient Study to Assess the Efficacy and Safety of a Modified Release Formulation of XX in Adult Primary Insomnia Patients with Sleep Maintenance Difficulties A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Outpatient study to assess the long-term safety and efficacy of two dose levels of a modified release formulation of XX in adult patients with primary insomnia A phase 3, randomized, double-blind, placebo-controlled, outpatient study to assess the efficacy and Safety of a modified release formulation of XX in elderly primary insomnia patients with sleep maintenance difficulties A Phase 3, Open-Label, Outpatient, Extension study to assess the Long-Term Safety of a modified release formulation of XX in elderly primary Insomnia patients with sleep maintenance difficulties. A Phase 3, randomized, double-blind, placebo-controlled, outpatient study to assess the efficacy and safety of a modified release XX in adult primary insomnia patients with sleep maintenance difficulties Patient Treatment Preference and Satisfaction with Migraine Headache Therapy XX vs Current Therapy A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of XX in Adult Migrainueurs for a Single Migraine Followed by Open Label Extensions to 26/52 Weeks Respiratory A Randomized, Double-Blind, Parallel-Group, Multicenter study to Compare Clinical Health Outcomes of XX versus XY in Outpatients with Community Acquired Lower Respiratory Tract Infections
10 A Comparative Study of the Safety, Efficacy and Effectiveness of XX Extended Release Tablets and XY for the Treatment of Subjects with Acute Exacerbation of Chronic Bronchitis. Comparative Study of the Safety and Efficacy of XX QD to Penicillin V TID in the Treatment of Streptococcal Pharyngitis / Tonsillitis A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled 12-Week Trial of Inhaled XX at three dosage levels versus Placebo in Propellant XY in Adolescent and Adult Subjects with Asthma who are Maintained on Bronchodilator Therapy. A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled 12-Week Trial of Inhaled XX –mcg BID, --mcg BID, and – mcg BID versus Placebo in Propellant XY in Adolescent and Adult Subjects with Asthma who are Maintained on Inhaled Corticosteroid Therapy.
An Open, Non-Comparative Multicenter Study to Assess the Efficacy and Safety of XX Twice Daily for 7 Days for the Treatment of Bacterial Community Acquired Pneumonia in Adults. Rheumatology A doubled-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Evaluate the clinical Equivalence of XX Gel with XY Gel in Patients with Osteoarthritis of the knee. A Multicenter, Randomized, Active-Control, Phase 3B Study to Evaluate the Cardiovascular Safety of Febuxostat and Allopurinol in subjects with Gout and Cardiovascular Comorbidities A Two-Arm Study Comparing the Analgesic Efficacy and Safety of XX Once-a-Day Versus Placebo for the Treatment of Pain due to Osteoarthritis A Randomized, Double-Blind, Phase 3 Study to Compare The Efficacy and Safety of XX in risk Reduction of NSAID-Associated Ulcers in Osteoarthritis Subjects Taking Low Dose Aspirin. A Randomized, Double-Blind, Multi-Center Study to Evaluate the Tolerability and Effectiveness of XX. vs. XY in Patients with Osteoarthritis A Comparative Efficacy and Safety Study of XX Delayed-Release Capsules Versus XY for the Healing of NSAID-associated Gastric Ulcers When Daily NSAID Use is Continued. A Comparative Efficacy and Safety Study of XX Delayed-Release Capsules Versus Placebo for the Prevention of Gastric Ulcers Associated with Daily NSAID Use in Patients at Risk. Longitudinal Examination of Arthritis Pain (LEAP) study A Two-Arm Study Comparing the Analgesic Efficacy and Safety of XX Once-a-Day Versus Placebo for the Treatment of Pain due to Osteoarthritis A Four-Arm Study Comparing Analgesic Efficacy and Safety of XX Once a day 100, 200 and 300 mg Versus Placebo for the Treatment of Pain due to Osteoarthritis of the Knee. A Double-Blind, Randomized, Stratified, Parallel-Group Study to Assess the Incidence of PUB’s during Chronic Treatment with XX or XY in Patients with Rheumatoid Arthritis. A Phase 2a Randomized, Double-blind, Placebo-controlled, Crossover Study of the Efficacy and Safety of XX in Subjects With Osteoarthritis of the Knee Urology A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel-group Trial with OLE to Demonstrate the Efficacy and Safety of XX Orally Disintegrating Tablets for Nocturia in Adult Males A Phase 3 at Home Use Study Evaluating the Efficacy and Safety of Escalating Doses of XX in the Treatment of Patients with Erectile Dysfunction ______
R. Krause CV Page 11 of 18 06-Feb-2017 Studies Conducted in Gastroenterology Indications Celiac Disease A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of XX in Patients with Celiac Disease. A Randomized, Double-Blind, Placebo Controlled Study to evaluate the efficacy and Safety of different doses of XX for the Treatment of Celiac Disease Chronic Idiopathic Constipation A Phase 3, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Trail of XX Administered Orally for 12 weeks Followed by a 4-week Randomized Withdrawal in Chronic Constipation A Trial to Evaluate the Long-term Tolerability, Safety, Subject Satisfaction, Pharmacokinetics and Use Patterns of Oral XX Tablets in Subjects with Chronic Idiopathic Constipation (CIC) A Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dose Titration on the Safety and Efficacy of XX Tablets in Subjects with Chronic Constipation A Randomized, Multicenter, Double-Blind, Parallel-design Phase 2 Trial of Oral XX Administered for 14 Days Once Daily at 100 ug, 300 ug, 1000 ug, or Placebo to Patients with Chronic Constipation A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Range finding, Parallel-Group, Phase 2 Trial of Oral XX Administered to Patients with Chronic Constipation Double Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Evaluate the Clinical Equivalence of XX and XY 24 mcg Capsules in treating CIC A Phase 2, Randomized, Placebo-Controlled Study of XX in Patients with Chronic Constipation Double Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Evaluate the Clinical Equivalence of XX 24 mcg Capsules with XX 24 mcg in the treatment of CIC A Randomized, 12-Week, Double-Blind, Placebo-Controlled, Repeat-Dose, Oral, Dose-Ranging Study to Assess the Safety and Efficacy of XX in Patients with CIC A Safety and Efficacy Evaluation of XX Laxative in Constipated Adults Dyspepsia A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose- Ranging Study of XX in Subjects with Functional Dyspepsia A randomized, double-blind, placebo-controlled, dose finding, multicenter study to assess the efficacy, safety and tolerability of XX given orally at three dose levels and placebo in patients with functional dyspepsia (FD) and documented delayed gastric emptying. A randomized, double-blind, placebo-controlled, dose finding, multicenter study to assess the efficacy, safety and tolerability of XX given orally at three dose levels and placebo in patients with functional dyspepsia (FD) and documented normal gastric emptying. A Twelve-Week Randomized, Double-Blind, Dose-Ranging, Placebo Controlled Study of XX in subjects with Non-Ulcer Dyspepsia A Double-Blind, Randomized, Placebo-Controlled Phase 2 Clinical Trial of XX for Treatment of Non- Ulcer Dyspepsia in Patients without Helicobacter Pylori. A Double-Blind, Randomized, Place-Controlled Phase 2 Clinical Trial of XX for Treatment of Non- Ulcer Dyspepsia in Patients with Helicobacter Pylori. Gastroparesis
12 A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy, Safety, and Tolerability of XX for the Treatment of Diabetic or Idiopathic Gastroparesis An Evaluation of the agreement between gastric emptying scintigraphy and the XX monitoring test and to assess both impact on patient management and diagnostic gain associated with the XX test A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of XX in Patients with Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 2a Study of Oral XX QD and BID for 4 Weeks to Patients with Diabetic Gastroparesis A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Assess the Effects of XX on Gastric Emptying Time in Diabetic Subjects with Gastroparesis A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Study of Safety, Efficacy and Dose Response of 28 Days of the Oral Motilin Receptor Agonist XX in Diabetic Gastroparesis Patients A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Effect of 12 weeks of the Oral Motilin Receptor Agonist XX in Diabetic Gastroparesis Patients A Phase 2, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of XX Administered to Patients with Diabetic Gastroparesis. Gastroesophageal Reflux Disease, Heartburn, and Reflux Efficacy and Safety of 10 mg XX for Treating Heartburn in Frequent Sufferers A Phase 2b, Double-blind, Randomized, Placebo-controlled, Dose-finding Study to Evaluate Efficacy of a Novel Selective 5-HT4 Receptor Agonist, XX Taken with a PPI in Subjects with Gastroesophageal Reflux Disease (GERD) with Persistent Regurgitation with or without Heartburn while on PPI Therapy Determination of Minimal Clinically Important Difference of the ReQuest Patient Self Assessment in Patients with Endoscopically-Confirmed GERD, Grade A-D (LA class.) treated with XX or Placebo An Open-Label Study of Once-Daily Oral Administration of XX 40 mg in Patients with Symptoms of GERD to Investigate the Relationship between the Presence of Erosive Esophagitis (EE) at Baseline and Heartburn Resolution after 4 Weeks of Treatment Investigation of the Prevalence of Clinically Relevant Esophageal Mucosal Pathology in XX Users A Phase 2 randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the efficacy and safety of a four-week treatment with XX for the relief of heartburn with GERD A Phase 2 randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the efficacy and safety of a four-week treatment with XX for the healing of acute EE A Double-Bind, Placebo-Controlled Study of XX 20mg Maintenance Intermittent Therapy Following Acute Treatment in Patients with Symptomatic GERD A randomized, double-blind, multicentre dose-finding Phase 2b study for up to 8 weeks' treatment with XX 25, 50, 75 mg and YY 40 mg, given orally once daily for the healing of erosive esophagitis A 4-Week, Randomized, Double-Blind, Dose-Finding Phase 2b Study with XX (20, 50, & 75mg) and XY 20mg, for the Treatment of GERD without EE (per LA classification) in Adults
R. Krause CV Page 13 of 18 06-Feb-2017 An Open label, Long term Safety Study to Assess the Safety of XX in Subjects with GERD A Comparative Efficacy and Safety Study of XX, and XY in Study Subjects with EE A Second Multi-Center, Double-Blind, Randomized, Single-Dose, Parallel Study to Evaluate the Efficacy of XX, XY and Placebo in Preventing Heartburn Symptoms A Multicenter, Double-Blind, Randomized Study Comparing Safety and Efficacy of Extended Release XX (daily and BID) and Placebo in Treating Symptomatic, Endoscopically Confirmed Erosive GERD A Study to Evaluate the Effect of XX on Symptoms Relief in Patients with Erosive Reflux Esophagitis A Multi-center, Randomized, Double-Blind, Eight Week Comparative Efficacy and Safety Study of XX in Study Subjects with EE A Randomized Double-Blind Parallel Study of XX Extended-Release 50mg Versus XX 40mg for Healing and Symptomatic Relief of Moderate to Severe Erosive GERD Qualitative Study to Develop a Heartburn Assessment Tool Interview Questionnaire Qualitative Assessment of Subjects with GERD who are Incomplete Responders to Approved PPI Therapy Interview Questionnaire A Randomized Double-Blind Parallel Study of XX Extended-Release 50 mg versus XY 40 mg for Healing & Symptomatic Relief of Moderate to Severe Erosive GERD A Dose-Response Efficacy and Safety Study of XX as Adjunctive Therapy in Subjects with GERD who are Incomplete Responders to a PPI A Randomized, Double-Blind, Placebo controlled, multi-center phase 2b dose finding study to assess the effect on GERD symptoms, safety and tolerability during 4 weeks treatment with XX in four dose levels as add-on treatment to a PPI in patients with GERD that are partial responders to PPI A Phase 2a Study to Evaluate the Effect of XX PO for 4 Weeks in Patients with GERD not Completely responsive to PPIs A Multicenter, Open-Label Trial to Evaluate the Safety of XX in Patients With Benign Gastric or Duodenal Ulcers, Symptomatic GERD or Erosive Esophagitis (EE) Efficacy and Safety of 10 mg XX for Treating Heartburn in Frequent Sufferers A Phase 3 Study to Evaluate the Efficacy and Safety of XX (60 mg QD and 90 mg QD) Compared to Placebo on Symptom Relief in Subjects with Symptomatic Non-Erosive GERD Irritable Bowel Syndrome A Study to Assess Repeat Treatment Efficacy and Safety of Rifaximin 550 mg TID in Subjects with Irritable Bowel Syndrome with Diarrhea (IBS-D) A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of XX in the Treatment of Patients with IBS-D A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Safety and Efficacy of Orally Administered XX in Subjects with IBS-D A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Safety and Efficacy of Orally Administered XX in Subjects with IBS-D
14 A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of XX for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C) A Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of XX in the Treatment of Patients With IBS-D A 12-wk Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Study of XX in IBS Subjects A Double-Blind, Randomized, Placebo-Controlled Phase 2b Study of XX in Females with IBS-D A Randomized, Double-blind, Placebo-controlled Study of XX in the Treatment of IBS-D A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Different Doses (275, 550, and 1100 mg) of XX Administered BID For Either Two or Four Weeks in the Treatment of Patients with IBS-D A Phase 3, Multicenter, Open Label, Extension Study to Evaluate the Long-Term Safety of XX 4 mg Once Daily in Women with IBS-C A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group Study of XX in Women with IBS-C A Randomized, Double-Blind, Placebo-Controlled, Multicenter 2-week Pilot Study to Evaluate the Efficacy, Safety and Tolerability of XX (25 and 100 mg bid) given Orally in Females with IBS-D A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study with PRN BID and Fixed Dosing Regimens of XX in Female Subjects with Severe IBS-D Who Have Failed Conventional Therapy A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of XX for the Symptomatic Treatment of IBS-D An Eight-Week, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of XX in Subjects with IBS A Randomized, Double-Blind, Multi-Center Study Comparing XX to Placebo for IBS Symptoms A 12 Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Safety and Efficacy of XX in Females with Severe IBS-D Who Have Failed Conventional Therapy A4 Week, Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel Group Study to Evaluate the Efficacy of XX in Relieving Symptoms of Females with IBS, Excluding those with IBS-D A Multicenter, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Low-Dose XX in Male Patients with IBS A Multicenter, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Low-Dose XX in Female Patients with IBS. A Double-Blind, Randomized, Placebo-Controlled Study of XX in Outpatients with IBS A 12 Week, Randomized, Double-Blind, Placebo-Controlled, Study of XX in Female Subjects With Alternating Diarrhea / Constipation (IBS-Alternating) A Study to Evaluate the Safety and Efficacy of XX Versus Placebo in Subjects with IBS A Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Investigate the Efficacy and Safety of XX in Non-Constipated Patients with Established IBS
R. Krause CV Page 15 of 18 06-Feb-2017 An Open-Label, Multi-Center Study to Investigate the Long-Term Safety of XX in Non-Constipated Patients with Established IBS A 12-Week, Observational Study of the Natural Disease Course in Females with IBS-Alternating A 12-Wk, Randomized, Double-Blind, Placebo-Controlled Study of XX in Females w/ IBS-Alternating A 1 Year Randomized, Double-Blind, Placebo-Controlled, Study of XX 1MG BID in Females with IBS A Phase 3, Randomized, Double-blind, Placebo-Controlled, Parallel-group Trial of XX Administered Orally for 26 Weeks in Patients with IBS-C An Open-Label, Long-Term Safety Study of Oral XX Administered to Patients with Chronic Constipation or IBS-C A Phase 2b, Double-Blind, Randomized, Placebo-controlled, Multi-centre, Dose-finding Efficacy and Safety Study of Range of Doses of XX in Patients with Chronic Idiopathic Constipation A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of XX for the Treatment of IBS-C A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of XX in the Treatment of Patients with IBS-D. Opioid-Induced Constipation A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Subcutaneous XX for Treating of Opiod-Induced Constipation (OIC) in Subjects with Chronic Non-Malignant Pain A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Oral XX for the Treatment of Opiod-Induced Bowel Dysfunction in Subjects with Chronic Non-Malignant Pain A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose, Dose Escalation Study to Evaluate the Efficacy, Safety and Tolerability of XX in patients with OIC A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel- group Study of Oral XX or the treatment of OIC in Subjects with Chronic, Non Malignant Pain A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of XX in Patients with Non-Cancer Related Pain and OIC A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of XX in subjects with OIC A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of XX in Relieving OIC in Patients with Cancer-Related Pain A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Long Term Safety And Tolerability of XX for OIC in Adults Taking Opioid Therapy for Non-Cancer Pain A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of XX in Patients with Non-Cancer Related Pain and OIC A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of XX in subjects with OIC Other Gastrointestinal Conditions A Randomized, Double-Blind, Placebo-Controlled Study of XX in the Treatment of Functional Diarrhea
16 Efficacy and Safety Study of Intra-Anal application of XX Ointment in subjects with Symptomatic Internal Hemorrhoids A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Treatment Group, Multicenter Efficacy and Safety Study of Intra-Anal application of XX Ointment in subjects with Symptomatic Internal Hemorrhoids. Double-Blind, dose response, randomized, placebo-controlled, parallel group, multi-centre phase 3 study on the efficacy and tolerability of XX vs. placebo for the prevention of recurrence of diverticulitis A Phase 3, Randomized, Double-Blind, Dose-Response, Stratified, Placebo-Controlled Study Evaluating the Safety and Efficacy of XX versus Placebo over 104 weeks in the Prevention of Recurrence of Diverticulitis A Phase 3 Randomized, Double Blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Fixed-dose Combination XX in Subjects with Moderately to Severely Active Crohn's Disease A Randomized, Double Masked, Placebo-Controlled Study of Subcutaneously Administered XX in Patients with Active Crohn’s Disease not treated with XY. A Multicenter, Randomized, Double-Blind, Actively Controlled Trial to Evaluate the Safety and Efficacy of New Formulation and Dosing Regimen of XX in Mildly-Moderately Active UC Colitis Comparison of the Performance of the EPI proColon and Fecal Immunochemical Test Post Colonoscopy in Subjects with Colorectal Cancer and Pre Colonoscopy Head to Head Study Epi proColon and FIT A Safety, Tolerance and Efficacy Evaluation of 3 Different Bowel Cleansing Treatments in Adult Subjects, Including the Elderly and subjects with Hepatic or Renal Insufficiency Procurement of Blood Samples from IBD, GI Controls and Healthy Volunteer Subjects for Use in the Development of Gastrointestinal Disease Tests A Randomized, Assessor-Blinded, Multi-Center Study Investigating the Efficacy, Safety, and Tolerability of 'Split-Dose' XX Versus XY for Colon Cleansing in Preparation for Colonoscopy A Phase 3 Study to Evaluate the Efficacy and Safety of XX (60 mg QD and 90 mg QD) and an Active Comparator, XY (30mg QD) on Healing of Erosive Esophagitis A Phase 3 Study to Evaluate the Safety and Efficacy of XX (60 mg QD and 90 mg QD) Compared to Placebo in Maintenance of Healing in Subjects with Healed Erosive Esophagitis Multicenter, Randomized, Active-Controlled Comparison Study of the Incidence of Gastroduodenal Ulcers Associated with XX + Low Dose ASA Vs. YY + Low Dose ASA in Subjects aged 50-75 yrs Comparison of the Efficacy and Safety of Three XX-Based Triple Therapy Regimens to XY-Based Triple Therapy for Eradication of Helicobacter Pylori An Efficacy and Safety Study of Intravenous XX in the Prevention of Recurrent Ulcer Bleeding After Successful Hemostasis A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either XX or Enteric Coated Aspirin 325 mg in Subjects who are at risk for Developing Aspirin-Associated Ulcers
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