Clinical trial NCT00597818: Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: NSAID-induced Gastroduodenal Injury
Ulcers
Rheumatoid Arthritis
Osteoarthritis
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2008-01-18
Enrollment: 121
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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 (other names: lubiprostone, SPI-0211, or RU-0211) at any time prior to participation in this study.

Primary outcomes:
measure: Number of Participants With Gastric Ulcers
timeFrame: at 20 months
Secondary outcomes:
measure: Number of Participants With Duodenal and Gastroduodenal Ulcers
timeFrame: at 20 months
measure: Number of Participants With Gastric, Duodenal, and Gastroduodenal Ulcers
timeFrame: at Week 4
measure: Size of Ulcers/Erosions
timeFrame: at 20 Months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Carl T Hayden VA Medical Center
state: Arizona
city: Chula Vista
country: United States
facility: Gregory J. Wiener, MD PC
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Physicians Medical Group
state: California
city: Mission Hills
country: United States
facility: Facey Medical Foundation
state: California
city: Palm Springs
country: United States
facility: Desert Oasis Healthcare
state: California
city: Sepulveda
country: United States
facility: Sepulveda Ambulatory Care Center
state: California
city: Pembroke Pines
country: United States
facility: University Clinical Research, Inc.
state: Florida
city: Chicago
country: United States
facility: University of Illinois Medical Center
state: Illinois
city: Baton Rouge
country: United States
facility: Gulf Coast Research, LLC
state: Louisiana
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Great Neck
country: United States
facility: Long Island Gastrointestinal Research Group
state: New York
city: New York
country: United States
facility: Research Associates of New York
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Gastroenterology
state: North Carolina
city: Oklahoma City
country: United States
facility: Oklahoma Founddation for Digestive Research
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Gastroenterology Section at Temple University Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: Dallas VA Research Corporation, Inc.
state: Texas
city: Houston
country: United States
facility: Houston Institute for Clinical Research
state: Texas
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
Study officials:
affiliation: Mallinckrodt
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: