Conditions: NSAID-induced Gastroduodenal Injury Ulcers Rheumatoid Arthritis Osteoarthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 121
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Participants receive matching placebo capsules for 20 months arm 2: Participants receive 18 mcg cobiprostone once daily (QD) for 20 months arm 3: Participants receive 18 mcg cobiprostone twice daily (BID) for 20 months arm 4: Participants receive 18 mcg cobiprostone three times daily (TID) for 20 months

Interventions: intervention 1: Cobiprostone intervention 2: Placebo intervention 3: Non-steroidal anti-inflammatory drug
Intervention descriptions: intervention 1: 18 mcg cobiprostone capsules for oral administration intervention 2: Matching placebo capsules for oral administration intervention 3: Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care.

Protocol document: