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Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury

This study has been completed.
Sponsor:
Information provided by:
Sucampo Pharma Americas, LLC
ClinicalTrials.gov Identifier:
NCT00597818
First received: January 10, 2008
Last updated: June 2, 2010
Last verified: June 2010
  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 Pharma Americas, LLC:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 24, 2014