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Clinical Trials/CTRI/2010/091/001055
CTRI/2010/091/001055
Completed
Phase 3

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

Cadila Healthcare Ltd6 sites in 1 country200 target enrollmentStarted: June 16, 2010Last updated:
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Overview

Phase
Phase 3
Status
Completed
Enrollment
200
Locations
6
Primary Endpoint
The endoscopic improvement rate
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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..

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Open Label

Eligibility Criteria

Ages
19.00 Year(s) to 75.00 Year(s) (—)
Sex
All

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.

Outcomes

Primary Outcomes

The endoscopic improvement rate

Time Frame: Baseline & 4 Weeks

Secondary Outcomes

  • Improvement in total score of GI symptoms(0, 1, 2, 3 & 4 weeks)

Investigators

Sponsor Class
Pharmaceutical industry-Indian

Study Sites (6)

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