Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury
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
1 other identifier
interventional
121
1 country
19
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 for 20 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2007
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 10, 2008
CompletedFirst Posted
Study publicly available on registry
January 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedResults Posted
Study results publicly available
December 26, 2019
CompletedDecember 26, 2019
March 1, 2018
1.7 years
January 10, 2008
March 22, 2018
December 10, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Gastric Ulcers
at 20 months
Secondary Outcomes (3)
Number of Participants With Duodenal and Gastroduodenal Ulcers
at 20 months
Number of Participants With Gastric, Duodenal, and Gastroduodenal Ulcers
at Week 4
Size of Ulcers/Erosions
at 20 Months
Study Arms (4)
Placebo
PLACEBO COMPARATORParticipants receive matching placebo capsules for 20 months
Cobiprostone QD
EXPERIMENTALParticipants receive 18 mcg cobiprostone once daily (QD) for 20 months
Cobiprostone BID
EXPERIMENTALParticipants receive 18 mcg cobiprostone twice daily (BID) for 20 months
Cobiprostone TID
EXPERIMENTALParticipants receive 18 mcg cobiprostone three times daily (TID) for 20 months
Interventions
18 mcg cobiprostone capsules for oral administration
Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 (other names: lubiprostone, SPI-0211, or RU-0211) at any time prior to participation in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Carl T Hayden VA Medical Center
Phoenix, Arizona, 85012, United States
Gregory J. Wiener, MD PC
Chula Vista, California, 91910, United States
Loma Linda University Physicians Medical Group
Loma Linda, California, 92354, United States
Facey Medical Foundation
Mission Hills, California, 91345, United States
Desert Oasis Healthcare
Palm Springs, California, 92262, United States
Sepulveda Ambulatory Care Center
Sepulveda, California, 91343, United States
University Clinical Research, Inc.
Pembroke Pines, Florida, 33024, United States
University of Illinois Medical Center
Chicago, Illinois, 60612, United States
Gulf Coast Research, LLC
Baton Rouge, Louisiana, 70808, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Long Island Gastrointestinal Research Group
Great Neck, New York, 11023, United States
Research Associates of New York
New York, New York, 10021, United States
University of North Carolina Gastroenterology
Chapel Hill, North Carolina, 27599, United States
Oklahoma Founddation for Digestive Research
Oklahoma City, Oklahoma, 73104, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Gastroenterology Section at Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Dallas VA Research Corporation, Inc.
Dallas, Texas, 75216, United States
Houston Institute for Clinical Research
Houston, Texas, 77074, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Information Call Center
- Organization
- Mallinckrodt Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Global Clinical Leader
Mallinckrodt
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2008
First Posted
January 18, 2008
Study Start
August 1, 2007
Primary Completion
April 1, 2009
Study Completion
May 1, 2009
Last Updated
December 26, 2019
Results First Posted
December 26, 2019
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share