Mucosta in Gastric Ulcer Treatment, Effectiveness and Safety Evaluation (MGES)

February 1, 2013 updated by: Otsuka Pakistan Limited

A Prospective Randomized, Multi-center Study to Assess the Safety and Efficacy of Mucosta (Rebamipide), in Combination With Omeprazole as Adjuvant Therapy in Gastric Ulcer Patients

A Prospective Randomized, Multi-center study to assess the Safety and Efficacy of Mucosta (Rebamipide), in combination with Omeprazole as adjuvant therapy in Gastric Ulcer Patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Karachi, Pakistan
        • Abbasi Shaheed Hospital
      • Karachi, Pakistan
        • Dow University of Health Sciences
      • Karachi, Pakistan
        • Dr. Ziauddin University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with dyspepsia or epigastric pain and endoscopically proven gastric and duodenal ulcers
  • Required laboratory parameters and time limits (screening blood tests will be taken including hemoglobin, white blood cell count, random glucose, potassium, sodium, chlorine, creatinine, AST, ALT, bilirubin, and alkaline phosphatase)
  • Age > 18 years
  • A statement that all patients must have signed an informed consent form prior to registration in study

Exclusion Criteria:

  • Patients who had undergone surgery for ulcers
  • History of hypersensitivity to drugs to be used in the study
  • Women who are pregnant or lactating or intended to get pregnant during the study period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mucosta and Omeprazole
Drug: Rebamipide and Omeprazole
open label, oral route, Rebamipide, 100mg tablet t.i.d and Omeprazole 20 mg tablet B.I.D. for 8 weeks
Other Names:
  • Mucosta
  • Omeprazole
Active Comparator: Omeperazole
Drug: Omeprazole
open label,oral route, Omeprazole 20mg tablet, B. I.D.; alone, for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing rates for gastric ulcer patients via endoscopic examination
Time Frame: 8 weeks treatment plus 4 weeks follow-up
8 weeks treatment plus 4 weeks follow-up
Improvement or absence of gastric ulcer associated symptoms
Time Frame: 8 weeks treatment plus 4 weeks follow-up
Improvement or absence of gastric ulcer associated symptoms, i.e. pain, burning, etc.
8 weeks treatment plus 4 weeks follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine and compare the Safety profile in both the treatment arms.
Time Frame: 8 weeks treatment plus 4 weeks follow-up
8 weeks treatment plus 4 weeks follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pakistan Limited

Investigators

  • Principal Investigator: Dr. Laeeque Ahmed, Asst. Professor, Dr. Ziauddin University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

June 23, 2010

First Submitted That Met QC Criteria

June 23, 2010

First Posted (Estimate)

June 24, 2010

Study Record Updates

Last Update Posted (Estimate)

February 4, 2013

Last Update Submitted That Met QC Criteria

February 1, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 037-POA-0901i

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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