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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
History of Changes
  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:

U.S. FDA Resources

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

ClinicalTrials.gov processed this record on June 13, 2013