Mucosta in Gastric Ulcer Treatment, Effectiveness and Safety Evaluation

Gastric Ulcer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150162
• Other study ID #: 037-POA-0901i
• Status: Completed
• Phase: Phase 3
• First received: June 23, 2010
• Last updated: February 1, 2013
• Start date: October 2010
• Est. completion date: August 2012

Study information

• Verified date: February 2013
• Source: Otsuka Pakistan Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: 1) Ministry of Health:Pakistan2) BioEthics IRB:Pakistan
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: August 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Ulcer
• Stomach Ulcer
• Ulcer

Intervention

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

Locations

Country	Name	City	State
Pakistan	Abbasi Shaheed Hospital	Karachi
Pakistan	Dow University of Health Sciences	Karachi
Pakistan	Dr. Ziauddin University Hospital	Karachi

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pakistan Limited

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing rates for gastric ulcer patients via endoscopic examination		8 weeks treatment plus 4 weeks follow-up	No
Primary	Improvement or absence of gastric ulcer associated symptoms	Improvement or absence of gastric ulcer associated symptoms, i.e. pain, burning, etc.	8 weeks treatment plus 4 weeks follow-up	No
Secondary	To determine and compare the Safety profile in both the treatment arms.		8 weeks treatment plus 4 weeks follow-up	Yes