Efficacy and Safety Study of TroxipTM In the Management of Acid Peptic Disorders
Phase 4
Completed
- Conditions
- Health Condition 1: K30- Functional dyspepsiaHealth Condition 2: K25- Gastric ulcerHealth Condition 3: K297- Gastritis, unspecifiedHealth Condition 4: K21- Gastro-esophageal reflux disease
- Registration Number
- CTRI/2012/11/003133
- Lead Sponsor
- Zuventus Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1486
Inclusion Criteria
1. Male and Female adult patients.
2. Patients need to be prescribed TroxipTM in order to be enrolled in the surveillance
program.
3. Patients of acid-peptic disorders. (Acid peptic disorders are defined as the diseases
of either acute or chronic occurrence in the oesophagus, stomach or duodenum.
These anatomical gastro-intestinal organs are affected due to the excess acid
secretion, which on symptomatic presentation as pain and discomfort by the
patients are classified as acid peptic disease).
4. Any other patient to be prescribed TroxipTM as per prescribing information or as per
prescribing physicianâ??s discretion.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and TolerabilityTimepoint: for 28 days
- Secondary Outcome Measures
Name Time Method EfficacyTimepoint: 28 days;patient complianceTimepoint: 28 days