PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity

Korea Otsuka Pharmaceutical Co., Ltd.396 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

396

Conditions

Rheumatoid Arthritis Osteoarthritis Ankylosing Spondylitis

Interventions

RebamipideDRUG

Rebamipide 100㎎, 12 weeks

MisoprostolDRUG

Misoprostol 200㎍ 12 weeks

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (10)

Unnamed facility

Bucheon-si, South Korea

Unnamed facility

Daegu, South Korea

Unnamed facility

Daejeon, South Korea

Unnamed facility

Gwangju, South Korea

Outcomes

Primary Outcomes

Incidence rate of gastric ulcer on gastroendoscopy result at 12-week

Time frame: 12 weeks

Secondary Outcomes

Rate of Therapeutic failure

Time frame: 12 weeks

Severity of gastrointestinal symptoms

Time frame: 12 weeks

Antacid consumption

Time frame: 12 weeks

Data from ClinicalTrials.gov

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