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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
121
18 mcg cobiprostone capsules for oral administration
Matching placebo capsules for oral administration
Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care.
Carl T Hayden VA Medical Center
Phoenix, Arizona, United States
Number of Participants With Gastric Ulcers
Time frame: at 20 months
Number of Participants With Duodenal and Gastroduodenal Ulcers
Time frame: at 20 months
Number of Participants With Gastric, Duodenal, and Gastroduodenal Ulcers
Time frame: at Week 4
Size of Ulcers/Erosions
Time frame: at 20 Months
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Gregory J. Wiener, MD PC
Chula Vista, California, United States
Loma Linda University Physicians Medical Group
Loma Linda, California, United States
Facey Medical Foundation
Mission Hills, California, United States
Desert Oasis Healthcare
Palm Springs, California, United States
Sepulveda Ambulatory Care Center
Sepulveda, California, United States
University Clinical Research, Inc.
Pembroke Pines, Florida, United States
University of Illinois Medical Center
Chicago, Illinois, United States
Gulf Coast Research, LLC
Baton Rouge, Louisiana, United States
Boston Medical Center
Boston, Massachusetts, United States
...and 9 more locations