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Clinical Trial Details (PDF Generation Date :- Sat, 25 Sep 2021 12:09:13 GMT)

CTRI Number CTRI/2009/091/000861 [Registered on: 18/12/2009] - Last Modified On 27/10/2018 Post Graduate Thesis No Type of Trial Interventional Type of Study Drug Study Design Randomized, Parallel Group, Active Controlled Trial Public Title of Study A clinical trial to study the effects of two drugs, fixed dose combination capsules of Pantoprazole sodium sesquihydrate & Cinitapride hydrogen tartrate ER and Pantoprazole sodium sesquihydrate tablets in patients with non-ulcer dyspepsia (NUD) or gastroesophageal reflux disease (GERD) Scientific Title of An open label comparative, multicentric study to assess the efficacy and safety of fixed dose Study combination capsules of Pantoprazole sodium sesquihydrate & Cinitapride hydrogen tartrate ER in comparison with Pantoprazole sodium sesquihydrate tablets in patients suffering from non-ulcer dyspepsia (NUD) or gastroesophageal reflux disease (GERD) Secondary IDs if Any Secondary ID Identifier Project No. 08-16 NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Ravindra Mittal Trial Coordinator (multi-center study) Designation Medical Advisor & Head - Regulatory Affairs Affiliation Address Cadila Healthcare Ltd. Zydus Tower, Satellite Cross Roads, Ahmadabad GUJARAT 380015 India Phone 07926868926 Fax 07926862362 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Ravindra Mittal Query) Designation Medical Advisor & Head - Regulatory Affairs Affiliation Address Cadila Healthcare Ltd. Zydus Tower, Satellite Cross Roads, Ahmadabad GUJARAT 380015 India Phone 07926868926 Fax 07926862362 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Ravindra Mittal Designation Medical Advisor & Head - Regulatory Affairs Affiliation Address Cadila Healthcare Ltd. Zydus Tower, Satellite Cross Roads, Ahmadabad GUJARAT 380015 India

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Phone 07926868926 Fax 07926862362 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Cadila Healthcare Ltd. Primary Sponsor Primary Sponsor Details Name Cadila Healthcare Ltd Address Zydus Tower, Satellite Cross Roads, Opp. ISCON Temple, Ahmedabad – 380 015 Type of Sponsor Pharmaceutical industry-Indian Details of Secondary Name Address Sponsor None Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr. Girish C. B.Y.L. Nair Hospital & Department of Rajadhyaksha T. N. Medical College, Medicine,B.Y.L. Nair [email protected] Mumbai Hospital & T. N. m Medical College, Mumbai- Mumbai MAHARASHTRA Dr. Sandeep Tak Dr. S.N. Medical Dept. of Medicine,Dr. College, Jodhpur S.N. Medical College- [email protected] Jodhpur RAJASTHAN Dr Mahendra Parmar Government Medical Dept. of 9824326550 College, Vadodara Medicine,Government Medical College,- mcparmar1961@yahoo Vadodara .co.in GUJARAT Dr. Praveen Garg Shashwat Hospital & Consultant Research Centre, Physician,Shashwat praveen_k_garg@yaho Ahmedabad Hospital & Research o.com Centre- Ahmadabad GUJARAT Dr. Paltial Palat Smt. N.H.L. Municipal Dept. of Medicine,Smt. Medical College & N.H.L. Municipal [email protected] Sheth V.S. Hospital, Medical College & m Ahmedabad Sheth V.S. Hospital- Ahmadabad GUJARAT Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Independent Ethics Approved 30/04/2009 Yes Committee - Aditya Independent Ethics Approved 30/04/2009 Yes Committee - Aditya Institutional Ethics Approved 11/08/2009 No Committee - B.Y.L. Nair Ch. Hospital & T.N.

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Medical College, Mumbai Institutional Ethics Approved 30/09/2009 No Committee - Dr. S.N. Medical College and Associated Group of Hospitals, Jodhpur Institutional Ethics Approved 21/07/2009 No Committee - Sheth V.S. General Hospital & Sheth Chinai Maternity Hospital, Ahmedabad Regulatory Clearance Status Date Status from DCGI Approved/Obtained 16/03/2009 Health Condition / Health Type Condition Problems Studied Patients Functional dyspepsia Patients Gastro-esophageal reflux disease without esophagitis Patients Non-ulcer dyspepsia (NUD) or gastroesophageal reflux disease (GERD) Intervention / Type Name Details Comparator Agent Intervention Fixed-dose combination Once in a day before meals for capsules of Pantoprazole 40 mg 4 weeks & Cinitapride ER 3 mg Comparator Agent Pantoprazole 40 mg tablets Once in a day before meals for 4 weeks Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 99.00 Year(s) Gender Both Details 1. Patients of either sex more than or equal to 18 years of age (No upper age limit was mentioned in our Protocol for this clinical trial).
2. Established diagnosis of non-ulcer dyspepsia (NUD) or gastroesophageal reflux disease (GERD) with gastrointestinal symptoms of at least moderate intensity.
3. Informed consent of the patient / relative. Exclusion Criteria Exclusion Criteria Details 1. Pregnancy and/or Lactation. 2. Patients with an increased gastrointestinal motility e.g. in patients with gastrointestinal hemorrhage, mechanical obstruction or perforation. 3. Patients with ulcerative dyspepsia and/or ulcerative gastritis 4. Patients with severe cardiac, pulmonary, hepatic or renal disease. 5. Patients on concomitant known to prolong QT interval. 6. Patients on concomitant medications known to affect action of Cinitapride like agents such as , psychotropic drugs, other dopaminergic agents, or hormones. 7. Patients with known hypersensitivity to Pantoprazole or Cinitapride or any other proton pump inhibitors or any other prokinetic agents. 8. Patients with any other serious concurrent illness or malignancy. 9. Patients with continuing history of and / or drug abuse. 10. Participation in another clinical trial in the past 3 months. Method of Generating Computer generated randomization

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Random Sequence Method of Centralized Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints The change in the mean intensity score of the 1,2,3 & 4 weeks symptoms (overall and individual) at the end of the study (Week 4) as compared to the baseline (prior to initiation of the therapy i.e. Week 0) Secondary Outcome Outcome Timepoints (1) Improvement in the mean intensity score of 1,2,3 & 4 weeks the symptoms (overall and individual) as estimated on a weekly basis. (2) Percentage of patients experiencing complete resolution of symptoms of reduced gastrointestinal motility at the end of the study i.e. 4 weeks. (3) Percentage of patients having endoscopic healing on upper G.I. endoscopy, if done. (4) Overall assessment of efficacy to the study at the end of the study Target Sample Size Total Sample Size=200 Sample Size from India=200 Final Enrollment numbers achieved (Total)= Final Enrollment numbers achieved (India)= Phase of Trial Phase 3 Date of First 18/07/2009 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=6 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Completed Trial (India) Publication Details none yet Brief Summary This study is an open label, comparative, multicentric study comparing the safety and efficacy of fixed-dose combination capsules of Pantoprazole & Cinitapride ER and Pantoprazole tablets once daily before meals each for 4 weeks in 200 patients with non-ulcer dyspepsia (NUD) or gastroesophageal reflux disease (GERD) that will be conducted in two centers in India. The primary outcome measures will be the change in the mean intensity score of the symptoms (overall and individual) at the end of the study as compared to the baseline.

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