PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity (PRESENT)

Otsuka

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis; Ankylosing Spondylitis; Rheumatoid Arthritis

Treatments: Drug: Misoprostol; Drug: Rebamipide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00576706

037-KOA-0701i

Details and patient eligibility

About

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.

Enrollment: 396 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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396 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Rebamipide

2

Active Comparator group

Treatment:

Drug: Misoprostol