PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity

Rheumatoid Arthritis Clinical Trial

— PRESENT  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00576706
• Other study ID #: 037-KOA-0701i
• Status: Completed
• Phase: Phase 3
• First received: December 17, 2007
• Last updated: November 15, 2011
• Start date: December 2007
• Est. completion date: March 2010

Study information

• Verified date: November 2011
• Source: Korea Otsuka Pharmaceutical Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis, Rheumatoid
• Osteoarthritis
• Rheumatoid Arthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Rebamipide
Rebamipide 100?, 12 weeks
• Misoprostol
Misoprostol 200? 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Korea Otsuka Pharmaceutical Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of gastric ulcer on gastroendoscopy result at 12-week		12 weeks	No
Secondary	Rate of Therapeutic failure		12 weeks	No
Secondary	Severity of gastrointestinal symptoms		12 weeks	No
Secondary	Antacid consumption		12 weeks	No