PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00576706

Acronym

PRESENT

Enrollment

396

Registered

2007-12-19

Start date

2007-12-31

Completion date

2010-03-31

Last updated

2011-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis, Osteoarthritis, Rheumatoid Arthritis

Keywords

Patients with rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis or any other arthritis-like disease requiring continuous NSAIDs therapy

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.

Interventions

DRUGRebamipide

Rebamipide 100㎎, 12 weeks

DRUGMisoprostol

Misoprostol 200㎍ 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence rate of gastric ulcer on gastroendoscopy result at 12-week	12 weeks

Secondary

Measure	Time frame
Rate of Therapeutic failure	12 weeks
Severity of gastrointestinal symptoms	12 weeks
Antacid consumption	12 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026