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.
- Conditions
- Health Condition 1: null- Acid Peptic Disorder
- Registration Number
- CTRI/2013/09/003944
- Lead Sponsor
- Government Medical College Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 100
• Patients with symptoms of dyspepsia having Glasgow Dyspepsia Severity Score > 2
OR
• Patients undergoing upper gastro intestinal endoscopy having signs of any of acid peptic disorder
AND
• Subjects who provide a written informed consent
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢ Proportion of patients with improvement of symptoms severity score <br/ ><br>â?¢ Proportion of patients with improvement on endoscopic evaluationTimepoint: â?¢ Symptom score: Day 0, Day 14, Day 28 <br/ ><br>â?¢ Endoscopic Evaluation: Day 0, Day 28
- Secondary Outcome Measures
Name Time Method â?¢ Adverse event frequency and severityTimepoint: As and when it occurs;â?¢ Global assessment of efficacy and tolerance by investigator at end of treatmentTimepoint: Day 0, Day 28;â?¢ Incidence of Rescue medication useTimepoint: Day 28;â?¢ Laboratory Investigations for safety assessmentTimepoint: Day 0, Day 28;â?¢ Symptom severity Sub scoresTimepoint: Day 0, Day 14, Day 28