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

Primary Purpose

Gastric Ulcer

Status
Completed
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
Rebamipide and Omeprazole
Omeprazole
Sponsored by
Otsuka Pakistan Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Ulcer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mucosta and Omeprazole

Omeperazole

Arm Description

Outcomes

Primary Outcome Measures

Healing rates for gastric ulcer patients via endoscopic examination
Improvement or absence of gastric ulcer associated symptoms
Improvement or absence of gastric ulcer associated symptoms, i.e. pain, burning, etc.

Secondary Outcome Measures

To determine and compare the Safety profile in both the treatment arms.

Full Information

First Posted
June 23, 2010
Last Updated
February 1, 2013
Sponsor
Otsuka Pakistan Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01150162
Brief Title
Mucosta in Gastric Ulcer Treatment, Effectiveness and Safety Evaluation
Acronym
MGES
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pakistan Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mucosta and Omeprazole
Arm Type
Experimental
Arm Title
Omeperazole
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Rebamipide and Omeprazole
Other Intervention Name(s)
Mucosta, Omeprazole
Intervention Description
open label, oral route, Rebamipide, 100mg tablet t.i.d and Omeprazole 20 mg tablet B.I.D. for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Omeprazole
Intervention Description
open label,oral route, Omeprazole 20mg tablet, B. I.D.; alone, for 8 weeks
Primary Outcome Measure Information:
Title
Healing rates for gastric ulcer patients via endoscopic examination
Time Frame
8 weeks treatment plus 4 weeks follow-up
Title
Improvement or absence of gastric ulcer associated symptoms
Description
Improvement or absence of gastric ulcer associated symptoms, i.e. pain, burning, etc.
Time Frame
8 weeks treatment plus 4 weeks follow-up
Secondary Outcome Measure Information:
Title
To determine and compare the Safety profile in both the treatment arms.
Time Frame
8 weeks treatment plus 4 weeks follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Laeeque Ahmed, Asst. Professor
Organizational Affiliation
Dr. Ziauddin University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abbasi Shaheed Hospital
City
Karachi
Country
Pakistan
Facility Name
Dow University of Health Sciences
City
Karachi
Country
Pakistan
Facility Name
Dr. Ziauddin University Hospital
City
Karachi
Country
Pakistan

12. IPD Sharing Statement

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Mucosta in Gastric Ulcer Treatment, Effectiveness and Safety Evaluation

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