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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pakistan Limited
ClinicalTrials.gov Identifier:
NCT01150162
First received: June 23, 2010
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Gastric Ulcer
Drug: Rebamipide and Omeprazole
Drug: Omeprazole
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Otsuka Pakistan Limited:

Primary Outcome Measures:
  • Healing rates for gastric ulcer patients via endoscopic examination [ Time Frame: 8 weeks treatment plus 4 weeks follow-up ] [ Designated as safety issue: No ]
  • Improvement or absence of gastric ulcer associated symptoms [ Time Frame: 8 weeks treatment plus 4 weeks follow-up ] [ Designated as safety issue: No ]
    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. [ Time Frame: 8 weeks treatment plus 4 weeks follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 129
Study Start Date: October 2010
Study Completion Date: August 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01150162

Locations
Pakistan
Dr. Ziauddin University Hospital
Karachi, Pakistan
Dow University of Health Sciences
Karachi, Pakistan
Abbasi Shaheed Hospital
Karachi, Pakistan
Sponsors and Collaborators
Otsuka Pakistan Limited
Investigators
Principal Investigator: Dr. Laeeque Ahmed, Asst. Professor Dr. Ziauddin University Hospital
  More Information

No publications provided

Responsible Party: Otsuka Pakistan Limited
ClinicalTrials.gov Identifier: NCT01150162     History of Changes
Other Study ID Numbers: 037-POA-0901i
Study First Received: June 23, 2010
Last Updated: February 1, 2013
Health Authority: 1) Ministry of Health:Pakistan
2) BioEthics IRB:Pakistan

Additional relevant MeSH terms:
Ulcer
Stomach Ulcer
Pathologic Processes
Peptic Ulcer
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Omeprazole
Rebamipide
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antioxidants
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014