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This study will observe the effect of Omeprazole on patient reported outcome measures in acid peptic disease

Prospective, observational, multi-centre, post marketing surveillance to measure the effectiveness of Omeprazole on patient reported outcome measures in acid peptic disease

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/04/024624
Enrollment
400
Registered
2020-04-14
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K279- Peptic ulcer, site unspecified, unspecified as acute or chronic, without hemorrhage or perforation

Interventions

None listed

Sponsors

Dr Reddys Laboratories Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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 3. Subject who has been prescribed omeprazole therapy as routine clinical management as per Investigator discretion.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
To evaluate Patient Assessment of Gastrointestinal Disorder Symptom Severity Index (PAGI-SYM) at Day 14Timepoint: Baseline, Day 14

Secondary

MeasureTime frame
To evaluate Patient Assessment of Gastrointestinal Disorder Symptom 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

Countries

India

Contacts

Public ContactSucheta Pandit

Dr. Reddys Laboratories

amey.mane@drreddys.com04049048400

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026