PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity - Full Text View

Sponsored by:	Korea Otsuka Pharmaceutical Co.,Ltd.
Information provided by:	Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier:	NCT00576706

Purpose

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.

Condition	Intervention	Phase
Rheumatoid Arthritis Osteoarthritis Ankylosing Spondylitis	Drug: Rebamipide Drug: Misoprostol	Phase III

Genetics Home Reference related topics: ankylosing spondylitis

MedlinePlus related topics: Ankylosing Spondylitis Osteoarthritis Rheumatoid Arthritis

Drug Information available for: Misoprostol Rebamipide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Korea Otsuka Pharmaceutical Co.,Ltd.:

Primary Outcome Measures:

Incidence rate of gastric ulcer on gastroendoscopy result at 12-week [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rate of Therapeutic failure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Degree and occurrence frequency of gastrointestinal symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Antacid consumption [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	396
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2008

Arms	Assigned Interventions
1: Experimental	Drug: Rebamipide Rebamipide 100㎎, 12 weeks
2: Active Comparator	Drug: Misoprostol Misoprostol 200㎍ 12 weeks

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576706

Contacts

Contact: Geumbo Lee

822-3465-5496

gb122@otsuka.co.kr

Locations

Korea, Republic of
	Recruiting
Daegu, Korea, Republic of
	Recruiting
Seoul, Korea, Republic of
	Recruiting
Suwon, Korea, Republic of
	Recruiting
Chonju, Korea, Republic of
	Recruiting
Pusan, Korea, Republic of
	Recruiting
Gwangju, Korea, Republic of
	Recruiting
Daejeon, Korea, Republic of

Sponsors and Collaborators

Korea Otsuka Pharmaceutical Co.,Ltd.

Investigators

Principal Investigator:

Soo-Heon Park, MD PhD

Catholic University Hospital

More Information

Responsible Party:	Korea Otsuka Pharmaceutical Co.,Ltd. ( Korea Otsuka Pharmaceutical Co.,Ltd. )
Study ID Numbers:	037-KOA-0701i
Study First Received:	December 17, 2007
Last Updated:	July 8, 2008
ClinicalTrials.gov Identifier:	NCT00576706
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Korea Otsuka Pharmaceutical Co.,Ltd.:

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

Study placed in the following topic categories:

Spinal Diseases
Autoimmune Diseases
Osteoarthritis
Spondylarthropathy
Joint Diseases
Misoprostol
Arthritis, Rheumatoid
Rheumatic Diseases
Rebamipide

Bone Diseases
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases
Spondylitis, Ankylosing
Spondylarthritis
Spondylitis
Ankylosis
Spondylarthropathies

Additional relevant MeSH terms:

Antioxidants
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Oxytocics
Physiological Effects of Drugs
Gastrointestinal Agents
Enzyme Inhibitors
Reproductive Control Agents

Infection
Abortifacient Agents, Nonsteroidal
Protective Agents
Pharmacologic Actions
Bone Diseases, Infectious
Therapeutic Uses
Abortifacient Agents
Anti-Ulcer Agents

ClinicalTrials.gov processed this record on January 16, 2009