A clinical trial to study effectiveness and safety of Revaprazan tablets in comparison with Omeprazole capsules in patients suffering from Peptic Ulcer or Acute Gastritis

A randomized, open label, comparative, multicentric study to assess the efficacy and safety of Revaprazan tablets in comparison with Omeprazole capsules in patients suffering from Peptic Ulcer or Acute Gastritis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001055

Enrollment

200

Registered

2010-06-29

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: K297- Gastritis, unspecified Health Condition 2: null- Peptic ulcer & Acute gastritis Health Condition 3: K279- Peptic ulcer, site unspecified, unspecified as acute or chronic, without hemorrhage or perforation

Interventions

Intervention1: Revaprazan 200 mg tablets: One tablet once daily for 4 weeks Control Intervention1: Omeprazole 20 mg capsules: One capsule once daily for 4 weeks

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex of 19 to 75 years of age. 2. Established diagnosis of peptic ulcer or acute gastritis. 3. Informed consent of the patient/relative.

Exclusion criteria

Exclusion criteria: 1. Pregnancy or Lactation. 2. Clinically significant disorder of liver, kidney, cardiovascular system, respiratory system, endocrine system and CNS. 3. Not eligible to undergo endoscopy. 4. Zollinger-Ellison syndrome. 5. Patients requiring use of any unacceptable concomitant medications 6. Patients with any other serious concurrent illness or malignancy. 7. Patients with continuing history of alcohol and / or drug abuse. 8. Participation in another clinical trial in the past 3 months.

Design outcomes

Primary

Measure	Time frame
The endoscopic improvement rateTimepoint: Baseline & 4 Weeks;The endoscopic improvement rateTimepoint: Baseline & 4 Weeks	—

Secondary

Measure	Time frame
Improvement in total score of GI symptomsTimepoint: 0, 1, 2, 3 & 4 weeks	—

Countries

India

Contacts

Public ContactDr Ravindra Mittal

Cadila Healthcare Ltd.

r.mittal@zyduscadila.com07926868926

Outcome results

None listed

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