A Multi-center, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Cobiprostone for the Prevention of NSAID-induced Gastroduodenal Injury in Patients With Osteoarthritis and/or Rheumatoid Arthritis Patients

NCT00597818 Phase 2 COMPLETED Results posted

The primary purpose of this study is to determine the efficacy and safety of three dose levels of cobiprostone as compared to placebo in OA/RA patients treated with an NSAID for 20 months.

Details

Lead sponsor	Sucampo Pharma Americas, LLC
Phase	Phase 2
Status	COMPLETED
Enrolment	121
Start date	2007-08
Completion	2009-05

Conditions

• NSAID-induced Gastroduodenal Injury
• Ulcers
• Rheumatoid Arthritis
• Osteoarthritis

Interventions

• Cobiprostone
• Placebo
• Non-steroidal anti-inflammatory drug

Primary outcomes

• Number of Participants With Gastric Ulcers — at 20 months

Countries

United States