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OpenTrials
Completed

NCT Number: NCT00576706

PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity

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.

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Key information

Conditions

Rheumatoid Arthritis Ankylosing Spondylitis Ankylosis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Axial Spondyloarthritis Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bucheon-si, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed written informed consent after being informed of the clinical trial
  • Males or females 19 years of age
  • Intake of any brand of NSAIDs in more than half of daily dose for at least the previous 4 weeks.

Exclusion criteria

  • Necessary to proceed in concomitant treatment with epileptic medications, anti-chollinergics, prokinetics, sucralfate
  • Presence or history of allergic drug reaction to the following medications; rebamipide, Misoprostol, NSAIDs designated to the protocol

Treatment and study plan

rebamipide

Drug

Rebamipide 100㎎, 12 weeks

Other names: Mucosta

Misoprostol

Drug

Misoprostol 200㎍ 12 weeks

Other names: Cytotec®

Primary outcomes

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

    Time frame: 12 weeks

Secondary outcomes

  1. Rate of Therapeutic failure

    Time frame: 12 weeks

  2. Severity of gastrointestinal symptoms

    Time frame: 12 weeks

  3. Antacid consumption

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Acronym: PRESENT

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Dec 19, 2007
Registry last updated
Nov 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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