Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury
This study has been completed.
Sponsor:
Sucampo Pharmaceuticals, Inc.
Information provided by:
Sucampo Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00597818
First received: January 10, 2008
Last updated: June 2, 2010
Last verified: June 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
NSAID-induced Gastroduodenal Injury Ulcers Rheumatoid Arthritis Osteoarthritis |
Drug: Cobiprostone Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Sucampo Pharmaceuticals, Inc.:
Primary Outcome Measures:
- Incidence of gastric ulcers [ Time Frame: Overall ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of patients developing duodenal and gastroduodenal ulcers [ Time Frame: Overall ] [ Designated as safety issue: No ]
- Proportion of patients developing gastric, duodenal, and gastroduodenal ulcers [ Time Frame: Weeks 4, 8, and 12 ] [ Designated as safety issue: No ]
- Change in number of ulcers by patient [ Time Frame: Overall ] [ Designated as safety issue: No ]
- Change in number of erosions by patient [ Time Frame: Overall ] [ Designated as safety issue: No ]
- Size of ulcers/erosions [ Time Frame: Overall ] [ Designated as safety issue: No ]
- Time-to-onset of ulcer/erosion development [ Time Frame: Overall ] [ Designated as safety issue: No ]
- Lanza assessment of gastroduodenal injury [ Time Frame: Weeks 4, 8, 12, and overall ] [ Designated as safety issue: No ]
- Analysis of dyspepsia/dyspeptic symptoms [ Time Frame: Weekly and overall ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | August 2007 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 1 |
Drug: Placebo
0 mcg capsules
|
|
Experimental: 2
Cobiprostone 18 mcg once daily (QD)
|
Drug: Cobiprostone
6 mcg and 12 mcg capsules
Other Name: SPI-8811
|
|
Experimental: 3
Cobiprostone 18 mcg twice daily (BID)
|
Drug: Cobiprostone
6 mcg and 12 mcg capsules
Other Name: SPI-8811
|
|
Experimental: 4
Cobiprostone 18 mcg three times daily (TID)
|
Drug: Cobiprostone
6 mcg and 12 mcg capsules
Other Name: SPI-8811
|
Eligibility| Ages Eligible for Study: | 40 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient is more than 40 and less than 70 years of age.
- Patient has confirmed osteoarthritis (OA) and/or rheumatoid arthritis (RA) and could benefit from NSAID therapy.
- No current gastrointestinal H. pylori infection.
Exclusion Criteria:
- Known allergy or hypersensitivity to NSAIDs, or has any other contraindicated condition(s) to NSAID therapy.
- 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 (lubiprostone, SPI-0211, or RU-0211) at any time prior to participation in this study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00597818
Locations
| United States, Arizona | |
| Carl T Hayden VA Medical Center | |
| Phoenix, Arizona, United States, 85012 | |
| United States, California | |
| Gregory J. Wiener, MD PC | |
| Chula Vista, California, United States, 91910 | |
| Loma Linda University Physicians Medical Group | |
| Loma Linda, California, United States, 92354 | |
| Facey Medical Foundation | |
| Mission Hills, California, United States, 91345 | |
| Desert Oasis Healthcare | |
| Palm Springs, California, United States, 92262 | |
| Sepulveda Ambulatory Care Center | |
| Sepulveda, California, United States, 91343 | |
| United States, Florida | |
| University Clinical Research, Inc. | |
| Pembroke Pines, Florida, United States, 33024 | |
| United States, Illinois | |
| University of Illinois Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Louisiana | |
| Gulf Coast Research, LLC | |
| Baton Rouge, Louisiana, United States, 70808 | |
| United States, Massachusetts | |
| Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| United States, New York | |
| Long Island Gastrointestinal Research Group | |
| Great Neck, New York, United States, 11023 | |
| Research Associates of New York | |
| New York, New York, United States, 10021 | |
| United States, North Carolina | |
| University of North Carolina Gastroenterology | |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, Oklahoma | |
| Oklahoma Founddation for Digestive Research | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Pennsylvania | |
| Altoona Center for Clinical Research | |
| Duncansville, Pennsylvania, United States, 16635 | |
| Gastroenterology Section at Temple University Hospital | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| United States, Texas | |
| Dallas VA Research Corporation, Inc. | |
| Dallas, Texas, United States, 75216 | |
| Houston Institute for Clinical Research | |
| Houston, Texas, United States, 77074 | |
| United States, Virginia | |
| Digestive and Liver Disease Specialists | |
| Norfolk, Virginia, United States, 23502 | |
Sponsors and Collaborators
Sucampo Pharmaceuticals, Inc.
Investigators
| Principal Investigator: | Byron Cryer, MD | Dallas VA Medical Center |
More Information
No publications provided
| Responsible Party: | Clinical Trial Manager, Sucampo Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00597818 History of Changes |
| Other Study ID Numbers: | SU0621 |
| Study First Received: | January 10, 2008 |
| Last Updated: | June 2, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Osteoarthritis Ulcer Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents |
ClinicalTrials.gov processed this record on June 17, 2013