Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00597818
Recruitment Status : Completed
First Posted : January 18, 2008
Last Update Posted : June 3, 2010
Information provided by:
Sucampo Pharma Americas, LLC

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.

Condition or disease Intervention/treatment Phase
NSAID-induced Gastroduodenal Injury Ulcers Rheumatoid Arthritis Osteoarthritis Drug: Cobiprostone Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Incidence of gastric ulcers [ Time Frame: Overall ]

Secondary Outcome Measures :
  1. Proportion of patients developing duodenal and gastroduodenal ulcers [ Time Frame: Overall ]
  2. Proportion of patients developing gastric, duodenal, and gastroduodenal ulcers [ Time Frame: Weeks 4, 8, and 12 ]
  3. Change in number of ulcers by patient [ Time Frame: Overall ]
  4. Change in number of erosions by patient [ Time Frame: Overall ]
  5. Size of ulcers/erosions [ Time Frame: Overall ]
  6. Time-to-onset of ulcer/erosion development [ Time Frame: Overall ]
  7. Lanza assessment of gastroduodenal injury [ Time Frame: Weeks 4, 8, 12, and overall ]
  8. Analysis of dyspepsia/dyspeptic symptoms [ Time Frame: Weekly and overall ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00597818

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.
Principal Investigator: Byron Cryer, MD Dallas VA Medical Center

Responsible Party: Clinical Trial Manager, Sucampo Pharmaceuticals, Inc. Identifier: NCT00597818     History of Changes
Other Study ID Numbers: SU0621
First Posted: January 18, 2008    Key Record Dates
Last Update Posted: June 3, 2010
Last Verified: June 2010

Additional relevant MeSH terms:
Wounds and Injuries
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases