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PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity — PRESENT  

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00576706
Study type Interventional
Source Korea Otsuka Pharmaceutical Co.,Ltd.
Contact
Status Completed
Phase Phase 3
Start date December 2007
Completion date March 2010
View Details
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