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: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

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

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
• Degree and occurrence frequency of gastrointestinal symptoms
  • Time Frame: 12 weeks
    Safety Issue?: No
• Antacid consumption
  • Time Frame: 12 weeks
    Safety Issue?: No

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

Lead Sponsor: Korea Otsuka Pharmaceutical Co.,Ltd.

Overall Clinical Trial Officials and Contacts

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

Overall Contact: Geumbo Lee 822-3465-5496 gb122@otsuka.co.kr

Information obtained from ClinicalTrials.gov on October 10, 2008

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