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PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity

NCT00576706 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 396

Last updated 2011-11-16

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Rebamipide

Rebamipide 100㎎, 12 weeks

DRUG

Misoprostol

Misoprostol 200㎍ 12 weeks

Sponsors & Collaborators

  • Korea Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Soo-Heon Park, MD PhD · Catholic University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00576706 on ClinicalTrials.gov