PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity

Verified by: Korea Otsuka Pharmaceutical Co.,Ltd., November 2011
First Received: December 17, 2007 | Last Updated: November 15, 2011 | Phase: Phase 3 | Start Date: December 2007
Overall Status: Completed | Estimated Enrollment: 396
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To prove that the efficacy and safety of Mucosta® (Rebamipide) is non-inferior to those of Cytotec® (Misoprostol), in terms of prevention of NSAID-induced gastric ulcer...

Brief Summary

Official Title: “A Phase III, Randomized, Double-dummy, Double Blind, Misoprostol-comparative Clinical Trial to Evaluate the Efficacy and Safety of Mucosta® Tablet in the Prevention of NSAID-induced Gastrointestinal Complications”

To prove that the efficacy and safety of Mucosta® (Rebamipide) is non-inferior to those of Cytotec® (Misoprostol), in terms of prevention of NSAID-induced gastric ulcer.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
  • Study Primary Completion Date: March 2010

Intervention(s) in this Clinical Trial

  • Drug: Rebamipide
    • Rebamipide 100㎎, 12 weeks
  • Drug: Misoprostol
    • Misoprostol 200㎍ 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
  • Active Comparator: 2

Outcome Measures for this Clinical Trial

Primary Measures

  • Incidence rate of gastric ulcer on gastroendoscopy result at 12-week
    • Time Frame: 12 weeks
      Safety Issue?: No

Secondary Measures

  • Rate of Therapeutic failure
    • Time Frame: 12 weeks
      Safety Issue?: No
  • Severity of gastrointestinal symptoms
    • Time Frame: 12 weeks
      Safety Issue?: No
  • Antacid consumption
    • Time Frame: 12 weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • 1. Signed written informed consent after being informed of the clinical trial
  • 2. Males or females 19 years of age
  • 3. Intake of any brand of NSAIDs in more than half of daily dose for at least the previous 4 weeks.

Exclusion Criteria:

  • 1. Necessary to proceed in concomitant treatment with epileptic medications, anti-chollinergics, prokinetics, sucralfate
  • 2. Presence or history of allergic drug reaction to the following medications;
  • rebamipide, Misoprostol, NSAIDs designated to the protocol

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 19 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Korea Otsuka Pharmaceutical Co.,Ltd. Industry

Overall Clinical Trial Officials and Contacts

Soo-Heon Park, MD PhD Principal Investigator Catholic University Hospital  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00576706

Study ID Number: 037-KOA-0701i

ClinicalTrials.gov Identifier: NCT00576706

Health Authority: Korea: Food and Drug Administration

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