PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity

Phase 3

Completed

• Conditions: Rheumatoid Arthritis; Osteoarthritis; Ankylosing Spondylitis
• Interventions: Drug: Rebamipide; Drug: Misoprostol

• Registration Number: NCT00576706
• Lead Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-17
• Study First Submitted QC: 2007-12-18
• Study First Posted: 2007-12-19
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-15
• Last Update Posted: 2011-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 396

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Rebamipide	-
2	Misoprostol	-

Primary Outcome Measures

Name	Time	Method
Incidence rate of gastric ulcer on gastroendoscopy result at 12-week	12 weeks

Secondary Outcome Measures

Name	Time	Method
Rate of Therapeutic failure	12 weeks
Severity of gastrointestinal symptoms	12 weeks
Antacid consumption	12 weeks