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

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ClinicalTrials.gov Identifier: NCT01150162
Recruitment Status : Completed
First Posted : June 24, 2010
Last Update Posted : February 4, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Gastric Ulcer Drug: Rebamipide and Omeprazole Drug: Omeprazole Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2010
Primary Completion Date : June 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Healing rates for gastric ulcer patients via endoscopic examination [ Time Frame: 8 weeks treatment plus 4 weeks follow-up ]
  2. Improvement or absence of gastric ulcer associated symptoms [ Time Frame: 8 weeks treatment plus 4 weeks follow-up ]
    Improvement or absence of gastric ulcer associated symptoms, i.e. pain, burning, etc.


Secondary Outcome Measures :
  1. To determine and compare the Safety profile in both the treatment arms. [ Time Frame: 8 weeks treatment plus 4 weeks follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01150162


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

Responsible Party: Otsuka Pakistan Limited
ClinicalTrials.gov Identifier: NCT01150162     History of Changes
Other Study ID Numbers: 037-POA-0901i
First Posted: June 24, 2010    Key Record Dates
Last Update Posted: February 4, 2013
Last Verified: February 2013

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