Mucosta in Gastric Ulcer Treatment, Effectiveness and Safety Evaluation

Brief Summary

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”

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 Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: June 2012

Interventions Used in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Mucosta and Omeprazole
  • Active Comparator: Omeperazole

Outcome Measures for this Clinical Trial

Primary Measures

  • Healing rates for gastric ulcer patients via endoscopic examination
    • Time Frame: 8 weeks treatment plus 4 weeks follow-up
      Safety Issue?: No
  • Improvement or absence of gastric ulcer associated symptoms
    • Time Frame: 8 weeks treatment plus 4 weeks follow-up
      Safety Issue?: No

Secondary Measures

  • To determine and compare the Safety profile in both the treatment arms.
    • Time Frame: 8 weeks treatment plus 4 weeks follow-up
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Otsuka Pakistan Limited
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dr. Laeeque Ahmed, Asst. Professor, Principal Investigator, Dr. Ziauddin University Hospital


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