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CTRI Trial Data PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Wed, 29 Sep 2021 01:52:07 GMT) CTRI Number CTRI/2013/09/003944 [Registered on: 02/09/2013] - Trial Registered Retrospectively Last Modified On 26/07/2013 Post Graduate Thesis Yes Type of Trial Interventional Type of Study Drug Study Design Randomized, Parallel Group, Multiple Arm Trial Public Title of Study A comparative study to evaluate the efficacy and safety of Troxipide (100 mg) and Rabeprazole (20 mg) alone and in combination in patients of Acid peptic disorders. Scientific Title of A prospective, comparative, controlled, randomized, open label, parallel, 3-arm study to evaluate Study and compare the efficacy and safety of Troxipide (100 mg) and Rabeprazole (20 mg) alone and in combination in patients suffering from acid peptic disorders Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Sagar Katare Trial Coordinator (multi-center study) Designation Junior Resident Affiliation Government Medical College, Aurangabad Address Department of Pharmacology, 3rd floor, College building, Government Medical College and Hospital (GHATI), Panchakki road, Navkheda Aurangabad MAHARASHTRA 431001 India Phone 9029015821 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Kantilal Chandaliya Query) Designation Associate Professor Affiliation Government Medical College, Aurangabad Address Department of Pharmacology, 3rd floor, College building, Government Medical College and Hospital (GHATI), Panchakki road, Navkheda Aurangabad MAHARASHTRA 431001 India Phone 9423149649 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Sagar Katare Designation Junior Resident Affiliation Government Medical College, Aurangabad Address Department of Pharmacology, 3rd floor, College building, Government Medical College and Hospital (GHATI), Panchakki road, Navkheda Aurangabad page 1 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in MAHARASHTRA 431001 India Phone 9029015821 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Government Medical College and Hospital, Panchakki road, Navkheda, Aurangabad - 431001 Primary Sponsor Primary Sponsor Details Name Government Medical College Hospital Address Government Medical College and Hospital (GHATI), Panchakki road, Navkheda, Aurangabad - 431001 Type of Sponsor Government medical college Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Sagar Katare GMCH Aurangabad Surgical OPD (No. 112) 9029015821 Government Medical College and Hospital [email protected] (GHATI), Panchakki road, Navkheda Aurangabad MAHARASHTRA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Ethics Approved 30/11/2011 No Committee, Government Medical College, Aurangabad Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Acid Peptic Disorder Intervention / Type Name Details Comparator Agent Intervention Troxipide 100 mg tablet to be administered thrice daily per orally for 28 days Comparator Agent Rabeprazole 20 mg tablet to be administered once daily per orally for 28 days Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 80.00 Year(s) Gender Both Details • Patients with symptoms of dyspepsia having Glasgow Dyspepsia Severity Score > 2<br/> OR<br/> • Patients undergoing upper gastro intestinal endoscopy having signs of any of acid peptic disorder<br/> AND<br/> • Subjects who provide a written informed consent<br/> page 2 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in Exclusion Criteria Exclusion Criteria Details • History of any diagnosed gastrointestinal disorder other than acid peptic disorder • History of any previous abdominal / gastrointestinal surgery • History of treatment with drugs capable of interfering with digestive mucosal integrity, acid secretion or gastrointestinal motility, (including H2 receptor antagonists, NSAIDs, muscarinic antagonists, cytoprotective agents) within the previous 7 daysys • Requires concomitant medication which precludes the evaluation of study medications • Patients with signs suggestive of any acute complication of acid peptic disorder • Any contraindication for endoscopy examination • Evidence of gastric malignancy, pyloric obstruction, or oesophageal stricture on endoscopy • Patients who are drug or alcohol abusers • Patients with known hypersensitivity to any of the ingredients of the test / Comparator formulation • Patients with impairment of renal or hepatic function, severe cardiac disease, any respiratory disease or haematological abnormality • Pregnant or lactating females • Simultaneous participation in another clinical study 30 days prior to the study Method of Generating Computer generated randomization Random Sequence Method of Not Applicable Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints • Proportion of patients with improvement of • Symptom score: Day 0, Day 14, Day 28 symptoms severity score • Endoscopic Evaluation: Day 0, Day 28 • Proportion of patients with improvement on endoscopic evaluation Secondary Outcome Outcome Timepoints • Symptom severity Sub scores Day 0, Day 14, Day 28 • Incidence of Rescue medication use Day 28 • Global assessment of efficacy and tolerance Day 0, Day 28 by investigator at end of treatment • Adverse event frequency and severity As and when it occurs • Laboratory Investigations for safety Day 0, Day 28 assessment Target Sample Size Total Sample Size=100 Sample Size from India=100 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial Phase 4 Date of First 02/07/2012 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=1 Trial Months=0 Days=0 page 3 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Closed to Recruitment of Participants Trial (India) Publication Details Brief Summary Acid peptic disorders (APD) is a collective term occuring typically as consequence of either hypersecretion of acid / pepsin or normal acid effect on diminished mucosal defence or both. APD is one of the most frequent reasons for medical consultation in Asian countries and has highly prevalence among the Asian population. APD though being a heterogeneous pathological condition, commonly presents will similar cluster of symptoms including Postprandial fullness, Early satiety, Bloating, Epigastric discomfort (poorly localized), Epigastric pain (a sharp, easy to pinpoint), Postprandial nausea, Belching after meals, Vomiting now collectively termed as Dyspepsia. The frequency of medical visits for dyspepsia has been found to increase with increasing age and with increasing severity of dyspeptic symptoms. As majority of the patients seek medical care only after the disease-related symptoms become more frequent or more severe, the current drug treatment is targeted towards symptomatic relief usually using empirical acid-suppressive therapy (PPI, H2 blockers, antacids) in primary care. Proton pump inhibitors (PPIs) are the most effective class of acid suppression agents providing maximum relief from dyspeptic symptoms. Rabeprazole is PPI with a faster onset of action and faster symptom control and also aid in gastric mucin synthesis. Since, APD is end result of an imbalance between mucosal defensive and aggressive factors a great deal of attention has been focused on role of the cytoprotective agents in strengthening the mucosal defensive factors. Troxipide is a new gastric cytoprotective agent with antiulcer, anti-inflammatory and mucus secreting properties. Though the exact mechanism of action of Troxipide is not fully elucidated, it has been clinically proven to heal gastritis and gastric ulcers. Cytoprotection and Acid suppression being two limbs of the etiopathology of Acid peptic disorders, drugs acting on both limbs may prove to be a potential synergism in outcome of the disease. This clinical study is hence been conducted to compare the relative efficacy of a cytoprotective agent, page 4 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in Troxipide; as monotherapy and in combination with an acid suppressive agent, Rabeprazole; in alleviating the symptoms of Acid Peptic Disorders against the currently followed treatment modality of acid suppression with proton pump inhibitors page 5 / 5 Powered by TCPDF (www.tcpdf.org).
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