Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00597818
• Other study ID #: SU0621
• Status: Completed
• Phase: Phase 2
• Start date: August 2007
• Est. completion date: May 2009

Study information

• Verified date: March 2018
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: May 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• NSAID-induced Gastroduodenal Injury
• Osteoarthritis
• Rheumatoid Arthritis
• Ulcers
• Wounds and Injuries

Intervention

Drug:
• Cobiprostone
18 mcg cobiprostone capsules for oral administration
• Placebo
Matching placebo capsules for oral administration
• Non-steroidal anti-inflammatory drug
Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care.

Locations

Country	Name	City	State
United States	Gulf Coast Research, LLC	Baton Rouge	Louisiana
United States	Boston Medical Center	Boston	Massachusetts
United States	University of North Carolina Gastroenterology	Chapel Hill	North Carolina
United States	University of Illinois Medical Center	Chicago	Illinois
United States	Gregory J. Wiener, MD PC	Chula Vista	California
United States	Dallas VA Research Corporation, Inc.	Dallas	Texas
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Long Island Gastrointestinal Research Group	Great Neck	New York
United States	Houston Institute for Clinical Research	Houston	Texas
United States	Loma Linda University Physicians Medical Group	Loma Linda	California
United States	Facey Medical Foundation	Mission Hills	California
United States	Research Associates of New York	New York	New York
United States	Digestive and Liver Disease Specialists	Norfolk	Virginia
United States	Oklahoma Founddation for Digestive Research	Oklahoma City	Oklahoma
United States	Desert Oasis Healthcare	Palm Springs	California
United States	University Clinical Research, Inc.	Pembroke Pines	Florida
United States	Gastroenterology Section at Temple University Hospital	Philadelphia	Pennsylvania
United States	Carl T Hayden VA Medical Center	Phoenix	Arizona
United States	Sepulveda Ambulatory Care Center	Sepulveda	California

Sponsors (1)

Lead Sponsor	Collaborator
Sucampo Pharma Americas, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Gastric Ulcers		at 20 months
Secondary	Number of Participants With Duodenal and Gastroduodenal Ulcers		at 20 months
Secondary	Number of Participants With Gastric, Duodenal, and Gastroduodenal Ulcers		at Week 4
Secondary	Size of Ulcers/Erosions		at 20 Months