This study will observe the effect of Omeprazole on patient reported outcomemeasures in acid peptic disease
- Conditions
- Health Condition 1: K279- Peptic ulcer, site unspecified, unspecified as acute or chronic, without hemorrhage or perforation
- Registration Number
- CTRI/2020/04/024624
- Lead Sponsor
- Dr Reddys Laboratories Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Subjects must voluntarily give consent in writing to participate in the
study by signing the Informed Consent Form (ICF)
2. Subjects of either sex diagnosed with acid peptic disease aged >=18
years and <=65 years.
3. Subject who has been prescribed omeprazole therapy as routine
clinical management as per Investigator discretion.
1. Hyper-sensitivity to any Proton pump inhibitor including omeprazole
in the past.
2. Participated in an investigational drug or investigational device study
within 30 days prior to the start of the study
3. Prior treatment for acid peptic disease histamine-2 receptor
antagonists or over the counter antacids during the week immediately
before the study
4. Any medical condition according to investigator which may interfere
with the treatment. Makes patient illegible for participation in study.
5. Planned surgical procedure during the duration of the study.
6. Women who are pregnant or breast-feeding and women who could
become pregnant during the study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate Patient Assessment of Gastrointestinal Disorder Symptom Severity Index (PAGI-SYM) at Day 14Timepoint: Baseline, Day 14
- Secondary Outcome Measures
Name Time Method To evaluate Patient Assessment of Gastrointestinal Disorder Symptom <br/ ><br>Severity Index (PAGI-SYM) at Day 28Timepoint: Baseline, Day 28;To evaluate Patient overall treatment satisfaction on Day 28Timepoint: Day 28;To evaluate Patients overall treatment satisfaction on Day 14Timepoint: Day 14