Mucosta in Gastric Ulcer Treatment, Effectiveness and Safety Evaluation

Phase 3

Completed

• Conditions: Gastric Ulcer
• Interventions: Drug: Rebamipide and Omeprazole; Drug: Omeprazole

• Registration Number: NCT01150162
• Lead Sponsor: Otsuka Pakistan Limited

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-23
• Study First Submitted QC: 2010-06-23
• Study First Posted: 2010-06-24
• Study Start: 2010-10
• Primary Completion: 2012-06
• Study Completion: 2012-08
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-01
• Last Update Posted: 2013-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mucosta and Omeprazole	Rebamipide and Omeprazole	-
Omeperazole	Omeprazole	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (3)

Abbasi Shaheed Hospital; 🇵🇰 Karachi, Pakistan

Dow University of Health Sciences; 🇵🇰 Karachi, Pakistan

Dr. Ziauddin University Hospital; 🇵🇰 Karachi, Pakistan