Mucosta in Gastric Ulcer Treatment, Effectiveness and Safety Evaluation

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01150162

Acronym

MGES

Enrollment

129

Registered

2010-06-24

Start date

2010-10-31

Completion date

2012-08-31

Last updated

2013-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Ulcer

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.

Interventions

DRUGRebamipide and Omeprazole

open label, oral route, Rebamipide, 100mg tablet t.i.d and Omeprazole 20 mg tablet B.I.D. for 8 weeks

DRUGOmeprazole

open label,oral route, Omeprazole 20mg tablet, B. I.D.; alone, for 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026