DOCSLIB.ORG

Reporting Adverse Drug Reactions

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Reporting Adverse Drug Reactions CIOMS ORGANIZATIONS1949 OF MEDICAL SCIENCES COUNCIL FOR INTERNATIONAL REPORTING ADVERSE 1999 REPORTING ADVERSE DRUG REACTIONS DRUG ADVERSE REPORTING DRUG REACTIONS DEFINITIONS OF TERMS AND CRITERIA FOR THEIR USE DEFINITIONS OF TERMS AND CRITERIA FOR THEIR USE TERMS AND CRITERIA FOR DEFINITIONS OF CIOMS publications may be obtained direct from CIOMS, c/o World Health Organization, Avenue Appia, 1211 Geneva 27, Switzerland. They are also distributed by the World Health Organization, Distribution and Sales Unit, Avenue Appia, 1211 Geneva 27, Switzerland and are available from booksellers through the network of WHO sales agents. A list of these agents may be obtained by writing to the above address. Price: SF 35.-- (including CD-ROM) REPORTING ADVERSE DRUG REACTIONS Definitions of Terms and Criteria for their Use Geneva Book and CD--Rom Copyright # 1999 by the Council for International Organizations of Medical Sciences (CIOMS) ISBN 92 9036 071 2 Printed in Switzerland Reprinted 2000 EDITORIAL GROUP Z. Bankowski R. Bruppacher I. Crusius J. Gallagher G. Kremer J. Venulet The Council for International Organizations of Medical Sciences (CIOMS) is a nongovernmental organization established jointly by the World Health Organization and UNESCO in 1949, with a mandate to collaborate with the United Nations and its specialized agencies. Its international membership, consisting of international unions and federations of national associations and societies, represents a substantial proportion of the world’s biomedical scientific community. Its secretariat is located in Geneva in offices made available by the World Health Organization. A dominant theme of CIOMS for some time has been the ethical aspects of biomedical technology and the bioethical considerations to be taken into account in determining and implementing health policy. A particular aspect of biomedical technology, the development and use of drugs, has been a second major theme. The independent status of CIOMS has permitted it to coordinate the contributions of research-based pharmaceutical companies, national drug regulatory authorities, and representative bodies of medical specialties to harmonizing and strengthening drug-safety surveillance measures. iv TABLE OF CONTENTS Page Acknowledgements .......................................................xi Foreword ............................................................... xiii Perspectives ............................................................. xv The World Health Organization................................. xv J.E. Ida¨npa¨a¨n-Heikkila¨ Drug Regulatory Authorities ................................... xvi G. Kreutz and M.M. Lumpkin TheViewofa Clinician........................................ xviii Ronald D. Mann The Pharmaceutical Industry .................................... xx W. Aellig, R. Bruppacher, G. Kremer, M. Pfeiffer, W. Spiegl and D. Tancrede Introduction .............................................................. 1 J. Venulet and Z. Bankowski Definitions and Basic Requirements for the Use of Terms for Reporting Adverse Drug Reactions ................................... 9 Skin and Appendages Disorders (SOC 0100) ............................ 9 Introduction........................................................... 9 Terms ................................................................ 10 Dermatitis (Eczema) ............................................. 10 Dermatitis exfoliative ............................................ 10 Fixed drug eruption.............................................. 11 Lichenoid drug eruption......................................... 11 Pustular eruption ................................................ 12 Urticaria / Angioedema.......................................... 12 Erythema multiforme ............................................ 13 Stevens-Johnson syndrome ...................................... 14 Toxic epidermal necrolysis....................................... 14 Photosensitivity reaction......................................... 15 Phototoxic reaction .............................................. 15 Photoallergic reaction............................................ 15 Musculo-Skeletal System Disorders (SOC 0200)....................... 16 Fracture pathological ............................................ 16 Myopathy ........................................................ 16 Myositis .......................................................... 17 Osteoporosis ..................................................... 17 v Collagen Disorders (SOC 0300) ........................................ 19 LE syndrome (Lupus erythematosus syndrome) ................ 19 Retroperitoneal fibrosis.......................................... 20 Vasculitis ......................................................... 21 Central and Peripheral Nervous System Disorders (SOC 0410)........ 23 General Introduction to Terms Designating Central and Peripheral Nervous System Disorders and Psychiatric Disorders ....................................... 23 Introduction to Terms Designating Disorders of the Central and Peripheral Nervous System ................................. 24 Terms ................................................................ 24 Anticholinergic syndrome ....................................... 24 Choreoathetosis.................................................. 25 Convulsions ...................................................... 26 Dyskinesia ....................................................... 27 Dysphonia ....................................................... 28 Dystonia ......................................................... 28 Encephalopathy.................................................. 29 Extrapyramidal disorder......................................... 29 Gait abnormal ................................................... 30 Hypertonia ....................................................... 30 Hypotonia........................................................ 31 Neuroleptic malignant syndrome................................ 31 Neuropathy ...................................................... 32 Oculogyric crisis ................................................. 33 Paralysis.......................................................... 33 Serotonin syndrome ............................................. 34 Speech disorder .................................................. 34 Vision Disorders (SOC 0431) ........................................... 36 Introduction.......................................................... 36 Terms ................................................................ 36 Cataract .......................................................... 36 Keratitis.......................................................... 36 Retinal disorder.................................................. 37 Vision abnormal ................................................. 37 Hearing and Vestibular Disorders (SOC 0432) ......................... 39 Ototoxicity....................................................... 39 Psychiatric Disorders (SOC 0500)...................................... 40 Introduction.......................................................... 40 Terms ................................................................ 40 Anorexia ......................................................... 40 Apathy........................................................... 41 vi Delirium.......................................................... 41 Depersonalization................................................ 42 Depression ....................................................... 43 Personality disorder.............................................. 43 Psychosis ......................................................... 44 Psychotic reaction................................................ 44 Thinking abnormal .............................................. 44 Thought disturbances............................................ 44 Gastro-Intestinal System Disorders (SOC 0600) ....................... 46 Abdominal pain.................................................. 46 Colitis ............................................................ 46 Colitis collagenous ............................................... 47 Constipation..................................................... 47 Diarrhoea ........................................................ 48 Dyspepsia ........................................................ 48 Gastritis .......................................................... 48 Gastrointestinal haemorrhage ................................... 49 Gastrointestinal infarction, Gastrointestinal necrosis, Gastrointestinal gangrene ..................................... 49 Haematemesis.................................................... 50 Haematochezia................................................... 50 Ileus.............................................................. 50 Intestinal ischaemia .............................................. 51 Intestinal obstruction ............................................ 51 Intestinal perforation ............................................ 52 Intestinal stenosis ................................................ 52 Melaena .......................................................... 53 Pancreatitis....................................................... 53 Peptic ulcer. ...................................................... 54 Peritonitis ........................................................ 55 Stomatitis ........................................................ 56
Load more

Recommended publications
  • Infection of the CNS by Scedosporium Apiospermum After Near Drowning
    205 CASE REPORT J Clin Pathol: first published as 10.1136/jcp.2003.8680 on 27 January 2004. Downloaded from Infection of the CNS by Scedosporium apiospermum after near drowning. Report of a fatal case and analysis of its confounding factors P A Kowacs, C E Soares Silvado, S Monteiro de Almeida, M Ramos, K Abra˜o, L E Madaloso, R L Pinheiro, L C Werneck ............................................................................................................................... J Clin Pathol 2004;57:205–207. doi: 10.1136/jcp.2003.8680 from the usual 15 days to up to 130 days. This type of This report describes a fatal case of central nervous system infection causes granulomata or abscesses and neutrophilic pseudallescheriasis. A 32 year old white man presented with meningitis.125 headache and meningismus 15 days after nearly drowning in a swine sewage reservoir. Computerised tomography and ‘‘In cases secondary to aspiration after near drowning, magnetic resonance imaging of the head revealed multiple once in the bloodstream, fungi seed into several sites but brain granulomata, which vanished when steroid and broad develop mainly in the central nervous system’’ spectrum antimicrobial and antifungal agents, in addition to dexamethasone, were started. Cerebrospinal fluid analysis To date, few cases of CNS pseudallescheriasis have been 2 disclosed a neutrophilic meningitis. Treatment with antibiotics described. However, such a diagnosis must should always be sought in individuals who have suffered near drowning in and amphotericin B, together with fluconazole and later standing polluted streams, ponds of water or sewage, or pits itraconazole, was ineffective. Miconazole was added with manure. through an Ommaya reservoir, but was insufficient to halt The case of a man who acquired a CNS P boydii infection the infection.
    [Show full text]
  • Adverse Events After Immunisation- Common and Uncommon
    Adverse events following Immunisation Common and Uncommon Dr Anna Clarke National Immunisation Office September 2016 www.immunisation.ie Abbreviations • ADR-adverse drug reaction • AE- adverse event • AEFI-adverse event following immunisation • SAE- serious adverse event • SUSAR-suspected unexpected serious adverse reaction Definitions • Adverse Drug Reaction – A response to a drug which is noxious and unintended, …occurs at doses normally used for the prophylaxis,.. or therapy of disease, … • Adverse Event – Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment Definitions Adverse Event Following Immunization (AEFI) Any untoward medical occurrence which follows immunisation and which does not necessarily have a causal relationship with the usage of the vaccine. The adverse event may be any unfavourable or unintended sign, abnormal laboratory finding, symptom or disease. AEFI 1. Loose definition to encourage reporting - does not restrict type of event - does not limit the time after immunisation - events, not reactions, are reported 2. Belief that immunisation was responsible may be correct, incorrect, or impossible to assess 3. Does not imply causality AEFIs Mild Reactions – Common – Include pain, swelling, fever, irritability, malaise – Self-limiting, seldom requiring symptomatic treatment But - important to inform parents about such events so they know about them Serious Adverse Event • Fatal • Life-threatening •
    [Show full text]
  • Reviewer Guidance
    Reviewer Guidance Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) February 2005 Good Review Practices Reviewer Guidance Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review Additional copies are available from: Office of Training and Communication Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 http://www.fda.gov/cder/guidance/index.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) February 2005 Good Review Practices TABLE OF CONTENTS I. INTRODUCTION............................................................................................................. 1 II. GENERAL GUIDANCE ON THE CLINICAL SAFETY REVIEW .......................... 2 A. Introduction....................................................................................................................................2 B. Explanation of Terms ....................................................................................................................3 C. Overview of the Safety Review .....................................................................................................4 D. Differences in Approach to Safety and Effectiveness Data ........................................................4
    [Show full text]
  • AHRQ Quality Indicators Fact Sheet
    AHRQ Quality Indicators Toolkit Fact Sheet on Inpatient Quality Indicators What are the Inpatient Quality Indicators? The Inpatient Quality Indicators (IQIs) include 28 provider-level indicators established by the Agency for Healthcare Research and Quality (AHRQ) that can be used with hospital inpatient discharge data to provide a perspective on quality. They are grouped into the following four sets: • Volume indicators are proxy, or indirect, measures of quality based on counts of admissions during which certain intensive, high-technology, or highly complex procedures were performed. They are based on evidence suggesting that hospitals performing more of these procedures may have better outcomes. • Mortality indicators for inpatient procedures include procedures for which mortality has been shown to vary across institutions and for which there is evidence that high mortality may be associated with poorer quality of care. • Mortality indicators for inpatient conditions include conditions for which mortality has been shown to vary substantially across institutions and for which evidence suggests that high mortality may be associated with deficiencies in the quality of care. • Utilization indicators examine procedures whose use varies significantly across hospitals and for which questions have been raised about overuse, underuse, or misuse. Mortality for Selected Procedures and Mortality for Selected Conditions are composite measures that AHRQ established in 2008. Each composite is estimated as a weighted average, across a set of IQIs, of the ratio of a hospital’s observed rate (OR) to its expected rate (ER), based on a reference population: OR/ER. The IQI-specific ratios are adjusted for reliability before they are averaged, to minimize the influence of ratios that are high or low at a specific hospital by chance.
    [Show full text]
  • Interventions for Treating Acute High Altitude Illness
    This document is downloaded from DR‑NTU (https://dr.ntu.edu.sg) Nanyang Technological University, Singapore. Interventions for treating acute high altitude illness Simancas‑Racines, Daniel; Arevalo‑Rodriguez, Ingrid; Osorio, Dimelza; Franco, Juan V.A.; Xu, Yihan; Hidalgo, Ricardo 2018 Simancas‑Racines, D., Arevalo‑Rodriguez, I., Osorio, D., Franco, J. V., Xu, Y., & Hidalgo, R. Interventions for treating acute high altitude illness. Cochrane Database of Systematic Reviews. (6), CD009567‑. doi:10.1002/14651858.CD009567.pub2 https://hdl.handle.net/10356/82999 https://doi.org/10.1002/14651858.CD009567.pub2 © 2018 The Cochrane Collaboration. All rights reserved. This paper was published by John Wiley & Sons, Ltd. in Cochrane Database of Systematic Reviews and is made available with permission of The Cochrane Collaboration. Downloaded on 28 Sep 2021 20:37:23 SGT [Intervention Review] Interventions for treating acute high altitude illness Daniel Simancas-Racines1, Ingrid Arevalo-Rodriguez1,2,3, Dimelza Osorio1, Juan VA Franco4, Yihan Xu5, Ricardo Hidalgo1 1Cochrane Ecuador. Centro de Investigación en Salud Pública y Epidemiología Clínica (CISPEC). Facultad de Ciencias de la Salud Eugenio Espejo, Universidad Tecnológica Equinoccial, Quito, Ecuador. 2Clinical Biostatistics Unit, Hospital Ramon y Cajal (IRYCIS), Madrid, Spain. 3CIBER Epidemiología y Salud Pública (CIBERESP), Madrid, Spain. 4Argentine Cochrane Centre, Instituto Universi- tario Hospital Italiano, Buenos Aires, Argentina. 5Wee Kim Wee School of Communication and Information, Nanyang Technological University, Singapore City, Singapore Contact address: Daniel Simancas-Racines, Cochrane Ecuador. Centro de Investigación en Salud Pública y Epidemiología Clínica (CISPEC). Facultad de Ciencias de la Salud Eugenio Espejo, Universidad Tecnológica Equinoccial, Quito, Ecuador. [email protected], [email protected].
    [Show full text]
  • Regulation of High-Altitude Hypoxia on the Transcription of CYP450 and UGT1A1 Mediated by PXR and CAR
    ORIGINAL RESEARCH published: 17 September 2020 doi: 10.3389/fphar.2020.574176 Regulation of High-Altitude Hypoxia on the Transcription of CYP450 and UGT1A1 Mediated by PXR and CAR † † Ya-bin Duan 1,2 , Jun-bo Zhu 1,2 , Jian-xin Yang 2, Gui-qin Liu 3, Xue Bai 1, Ning Qu 4*, Xue-jun Wang 5* and Xiang-yang Li 2* Edited by: 1 Research Center for High Altitude Medicine, Qinghai University Medical College, Xining, China, 2 State Key Laboratory of Yurong Lai, Plateau Ecology and Agriculture, Qinghai University, Xining, China, 3 College of Eco-Environmental Engineering, Qinghai Gilead, United States University, Xining, China, 4 Department of Anesthesiology, Qinghai Hospital of Traditional Chinese Medicine, Xining, China, 5 Reviewed by: Department of Anesthesiology, Red Cross Hospital of Qinghai, Xining, China Cindy Yanfei Li, Amgen, United States Little is known about what roles the pregnane X receptor (PXR) and constitutive Xavier Decleves, Universite´ Paris Descartes, France androstane receptor (CAR) play in drug metabolism in high-altitude hypoxia. Likewise, *Correspondence: the potential interaction of nuclear receptors and drug metabolism enzymes during drug Ning Qu metabolism of high-altitude hypoxia is not fully understood. In this work, we investigated [email protected] Xue-jun Wang the effects of high-altitude hypoxia on transcriptional regulation of cytochrome P450 [email protected] (CYP450) and UDP-glucuronosyltransferase 1A1 (UGT1A1) genes mediated by PXR and Xiang-yang Li CAR proteins. The protein and mRNA expressions of CYP450, UGT1A1, PXR, and CAR [email protected] were determined by enzyme-linked immunosorbent assay and qPCR in rats and HepG2 †These authors share first authorship cell lines under hypoxia.
    [Show full text]
  • Adverse Drug Reaction Reporting
    P T Chapter 40 Adverse Drug Reaction Reporting Lee B. Murdaugh, RPh, PhD The Conditions of Participation standards of the Centers for Medicare & Medicaid Services (CMS) and the standards of accrediting organizations such as The Joint Commission, the Healthcare Facilities Accredi- tation Program (HFAP), and the National Integrated Accreditation for Healthcare Organizations (NIAHOSM) require hospitals to identify and report adverse drug reactions (ADRs). These ADRs must be reported to LEARNING OBJECTIVES patients’ attending physicians and the hospital’s quality assessment and performance improvement program. Additionally, hospitals are expected to report serious • Define an adverse drug reaction. ADRs (as defined by the Food and Drug Administration • Discuss the detection of adverse [FDA]) to the FDA’s MedWatch program and ADRs to vaccines to the FDA’s Vaccine Adverse Events Reporting drug reactions. System (VAERS). • Discuss the assessment of adverse drug reactions. Defining Adverse Drug Reactions To recognize and assess ADRs, there must be a defini- tion of what constitutes an ADR. Examples of commonly used definitions are discussed in the following text. The FDA defines a serious adverse reaction as one in which “the patient outcome is death, life threat- ening (real risk of dying), hospitalization (initial or prolonged), disability (significant, persistent, or perma- nent), congenital anomaly, or required intervention to prevent permanent impairment or damage.”1 The American Society of Health-System Pharma- cists (ASHP) defines a ADR as “any unexpected, unin- tended, undesired, or excessive response to a drug that • requires discontinuing the drug (therapeutic or diagnostic) • requires changing the drug therapy • requires modifying the dose (except for minor dosage adjustments) • necessitates admission to a hospital 546 Competence Assessment Tools for Health-System Pharmacies • prolongs stay in a healthcare facility routine observation and assessment.
    [Show full text]
  • Adverse Drug Reactions – Allergy? Side-Effect? Intolerance?
    Medications Adverse drug reactions Allergy? Side-effect? Intolerance? William Smith Background There are two common situations that require assessment Adverse drug reactions (ADRs) vary from life-threatening of adverse drug reactions (ADRs): anaphylaxis to minor common side-effects. • Current reaction: a patient develops new symptoms while taking a particular drug. Is the drug the cause of the Objective symptoms and if so, should it be stopped? To provide an overview on the assessment of ADRs. To discuss the features of what may be described as a ‘reaction • Previous reaction: in the recent or distant past; often the to a drug’ in order to highlight those suggestive of allergy, patient’s recall is poor and information is lacking. Can the side-effect or intolerance, and what implications this might drug be used again? have for the future use or avoidance of the drug. In the setting of a current reaction, it is important to make a thorough Discussion assessment of the nature and severity of the ADR, and where not Assessment of an ADR may apply to a current reaction or a history of a past reaction. The main decision is whether to obvious, refer to available information on the known side-effects of cease the drug and/or whether it can be used again. Some the medication in question. Where allergy is suspected, testing may ADRs are serious and likely to be reproducible and constitute be helpful. For example, serum tryptase in the case of suspected absolute contraindications, whereas others are mild and may anaphylaxis, eosinophilia in a chronic reaction, and skin biopsy in or may not occur on subsequent exposure.
    [Show full text]
  • Study Protocol
    Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Study Title Healthy Adults NCT Number NCT03828149 Document Description Clinical Protocol, Version: V04_0 Document Date 08 Jan 2019 TRIAL PROTOCOL EVALUATION OF SAFETY AND PHARMACODYNAMICS OF OP0201 COMPARED TO PLACEBO IN HEALTHY ADULTS Novus Therapeutics, Inc. xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 19900 MacArthur Blvd., Suite 550 xxxxxxxxxxxxxxxxxxxxxxxxxxxxx Irvine, California 92612, U.S.A. xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx (Sponsor) xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx represented by xxxxxxxxxxxxxxxxxxxxxxxxxxx University of Cologne xxxxxxxxxxxxxxxxxxx Albertus-Magnus-Platz xxxxxxxxxxxxx 50923 Cologne Germany xxxxxxx (EU Sponsor Representative) Novus TherapeuticsTrial Protocol Code: OP0201-C001 University of Cologne Internal Trial Protocol Code: Uni-Koeln-2809 EudraCT number: 2016-003667-19 08-01-2018, Version V04_0 The information in this trial protocol is strictly confidential. It is for the use of the Sponsor, investigator, trial personnel, ethics committee, the authorities, and trial subjects only. This trial protocol may not be passed on to third parties without the express agreement of the Sponsor or the Principal Coordinating Investigator (PCI, “Leiter der klinischen Prüfung (LKP)”). Trial protocol V04_0 of 08-01-2018 Novus Therapeutics, Inc. by University of Cologne OP0201-C001 Page 2 of 66 I. Signatures xxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Signature Date xxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxx
    [Show full text]
  • NCCMERP Fact Sheet 2015-02-V9.Indd
    Questions About NCC MERP and Medication Errors Shawn C. Becker, M.S., B.S.N., Director Healthcare Quality Standards, Science and Standards Division [email protected] / (301) 816–8216 tel / (301) 816-8532 fax Contemporary View of Medication– Related Harm. A New Paradigm Introduction Scenario/Case Studies The NCC MERP has frequently been asked to help healthcare Medication error resulting in no harm professionals distinguish among Adverse Drug Events (ADEs), Case 1. A 25 kg child with no prior history of penicillin allergy was Adverse Drug Reactions (ADRs) and Medication Errors. The Council prescribed 250 mg orally of amoxicillin suspension twice daily notes several defi nitions for these terms in the literature, research (morning and evening) for 7 days. On the seventh day, the child reports, and by various organizations. The terms ADE and ADR inadvertently received a morning dose of 500 mg instead of 250 mg. have been used when patient harm has occurred as a result of a The child did not suff er any negative consequences from the error. drug (see defi nitions). To further clarify, an ADR has been defi ned as harm that results from a medication dose that is “normally used in A preventable ADE (medication-related harm due to error) man.” An ADE has been defi ned as harm associated with any dose Case 2. A 74 year old female with acute leg pain presented to of a drug, whether the dose is “normally used in man” or not. An the emergency department. She has a history of sleep apnea. ADR, therefore, is a subtype of an ADE (i.e., all ADRs are ADEs, but She has no previous history of opioid use.
    [Show full text]
  • Adverse Drug Reaction Questionnaire
    Name: ______________________ Date: ______________________ ADVERSE DRUG REACTION QUESTIONNAIRE Demographic Data Name: _____________________________ DOB: ________________ Date: ________________ Address: ______________________________________________________________________ Telephone: Home___________________________________ Work: ___________________________________ Cell: ____________________________________ Emergency Contact: _____________________________________________________________ Relation: ______________________________________________________________________ Address: ______________________________________________________________________ Telephone: ______________________________ Referring Physician: _____________________________________________________________ Address: ______________________________________________________________________ Telephone: _____________________________ 1 Name: ______________________ Date: ______________________ Allergy History Chief Complaint: What Medication caused your reaction? ______________________________________________________________________________________ Why were you receiving this medication? ______________________________________________________________________________________ When did you receive this medication? ________________________________________________________________________________________ How many times have you received this medication? _____________________________________________________________________________ Do you receive other medications with or just before this medication?
    [Show full text]
  • Study Protocol, Independently of the Fact That the Patient Is a Completer Or a Withdrawn Patient
    CONFIDENTIAL rhNGF in Post Cataract and Refractive Surgery Sponsor code NGF0116 Final Version 3.0 12 Apr 2017 Study code NGF0116 A 8 weeks, Phase II, single-centre, randomized, double-masked, vehicle-controlled, parallel group study with 4 weeks of follow-up to evaluate preliminary efficacy and safety of recombinant human Nerve Growth Factor (rhNGF) eye drops solution versus vehicle in patients after cataract and refractive surgery. Double-masked, single-centre, two-group, one dose, efficacy and safety study EudraCT Number: 2016-002172-27 Test formulation: Recombinant human nerve growth factor (rhNGF), 20 μg/ml, ophthalmic sterile buffered aqueous solution, Dompé farmaceutici s.p.a., Italy Sponsor: Dompé farmaceutici S.p.A., Via Santa Lucia 6, 20122 Milan, Italy Phone: +39.02.583831 Fax: +39.02.58383324 Contact: Paolo Battigello Email: [email protected] Principal Investigator Prof. Leonardo Mastropasqua, MD Clinica Oftalmologica - Centro regionale di Eccellenza in Oftalmologia Università G. D' Annunzio Via dei Vestini 66100 Chieti, Italy Phone: +39.0871.35713581 Fax: +39.0871.358794 Development phase: Phase II Version and date: Final Version 3.0, 12 Apr 2017 This study will be conducted in accordance with Good Clinical Practice (GCP), ICH topic E6 Property of the Sponsor May not be used, divulged, published or otherwise disclosed without the consent of the Sponsor Page 1 of 59 CONFIDENTIAL rhNGF in Post Cataract and Refractive Surgery Sponsor code NGF0116 Final Version 3.0 12 Apr 2017 PROTOCOL APPROVAL SPONSOR Dompé farmaceutici S.p.A. , Italy Clinical Development Senior Specialist Paolo Battigello, M.Sc. Date Signature Medical Expert Flavio Mantelli, MD, PhD Date Signature INVESTIGATORS Principal Investigator Investigator Agreement: I have read the clinical study described herein, recognize its confidentiality, and agree to conduct the described trial in compliance with Good Clinical Practice (GCP), the ethical principles contained within the Declaration of Helsinki, this protocol, and all applicable regulatory requirements.
    [Show full text]