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

Phase 3

Completed

• Conditions: Gastritis, unspecified, Peptic ulcer & Acute gastritis, (2) ICD-10 Condition: K279||Peptic ulcer, site unspecified, unspecified as acute or chronic, without hemorrhage or perforation,

• Registration Number: CTRI/2010/091/001055
• Lead Sponsor: Cadila Healthcare Ltd

Brief Summary

This study is an open label, comparative, multicentric study comparing the safety and efficacy of Revaprazan 200 mg tablets and Omeprazole 20 mg capsules given once daily each for 4 weeks; in 200 patients with Peptic Ulcer or Acute Gastritis that will be conducted in India. The primary outcome measures will be the endoscopic improvement rate and symptomatological improvement rate at the end of study..

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-16
• Last Update Posted: 2018-11-13

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

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

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 medications6.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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The endoscopic improvement rate	Baseline & 4 Weeks

Secondary Outcome Measures

Name	Time	Method
Improvement in total score of GI symptoms	0, 1, 2, 3 & 4 weeks

Trial Locations

Locations (6)

Dr. Manish Bhatnagar's Clinic; 🇮🇳 Ahmadabad, GUJARAT, India

Dr. Nijhawan Clinic, Jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

GUT-N-HEPA CARE, Indore; 🇮🇳 Indore, MADHYA PRADESH, India

K2 Clinic, Jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

Kala Endoscopy & Liver Clinic, Jodhpur; 🇮🇳 Jodhpur, RAJASTHAN, India

L.T.M. Medical College & General Hospital, Mumbai; 🇮🇳 Mumbai, MAHARASHTRA, India

Dr. Manish Bhatnagar's Clinic

🇮🇳Ahmadabad, GUJARAT, India

Dr. Manish Bhatnagar

Principal investigator

man_bhatnagar@yahoo.com