CompletedPhase 3

PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity

South Korea396 participantsStarted 2007-12

Plain-language 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.

Who can participate

Age range19 Years

SexALL

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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

What they're measuring

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

Timeframe: 12 weeks

Trial details

NCT IDNCT00576706

SponsorKorea Otsuka Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-03

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