Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury
NCT ID: NCT00597818
Last Updated: 2019-12-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
121 participants
INTERVENTIONAL
2007-08-31
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants receive matching placebo capsules for 20 months
Placebo
Matching placebo capsules for oral administration
Non-steroidal anti-inflammatory drug
Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care.
Cobiprostone QD
Participants receive 18 mcg cobiprostone once daily (QD) for 20 months
Cobiprostone
18 mcg cobiprostone capsules for oral administration
Non-steroidal anti-inflammatory drug
Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care.
Cobiprostone BID
Participants receive 18 mcg cobiprostone twice daily (BID) for 20 months
Cobiprostone
18 mcg cobiprostone capsules for oral administration
Non-steroidal anti-inflammatory drug
Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care.
Cobiprostone TID
Participants receive 18 mcg cobiprostone three times daily (TID) for 20 months
Cobiprostone
18 mcg cobiprostone capsules for oral administration
Non-steroidal anti-inflammatory drug
Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care.
Interventions
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Cobiprostone
18 mcg cobiprostone capsules for oral administration
Placebo
Matching placebo capsules for oral administration
Non-steroidal anti-inflammatory drug
Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient has confirmed osteoarthritis (OA) and/or rheumatoid arthritis (RA) and could benefit from NSAID therapy.
* No current gastrointestinal H. pylori infection.
Exclusion Criteria
* Patient has undergone a gastrointestinal or abdominal surgical procedure within 90 days prior to the Screening Visit, or has had a bowel resection at any time.
* Medical history includes prior or active GI complications and/or disorders, including but not limited to Barrett's esophagus, erosive esophagitis, esophageal stricture or ring, gastric obstruction, irritable bowel syndrome (IBS), or inflammatory bowel disease (IBD).
* Active symptomatic peptic ulcer disease or GI bleeding.
* Patient has received cobiprostone (SPI-8811; RU-8811) or AMITIZA (other names: lubiprostone, SPI-0211, or RU-0211) at any time prior to participation in this study.
40 Years
70 Years
ALL
No
Sponsors
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Sucampo Pharma Americas, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Mallinckrodt
Locations
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Carl T Hayden VA Medical Center
Phoenix, Arizona, United States
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
Long Island Gastrointestinal Research Group
Great Neck, New York, United States
Research Associates of New York
New York, New York, United States
University of North Carolina Gastroenterology
Chapel Hill, North Carolina, United States
Oklahoma Founddation for Digestive Research
Oklahoma City, Oklahoma, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Gastroenterology Section at Temple University Hospital
Philadelphia, Pennsylvania, United States
Dallas VA Research Corporation, Inc.
Dallas, Texas, United States
Houston Institute for Clinical Research
Houston, Texas, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
Countries
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Other Identifiers
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SU0621
Identifier Type: -
Identifier Source: org_study_id