Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00597818
Other study ID # SU0621
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date August 2007
Est. completion date May 2009

Study information

Verified date March 2018
Source Mallinckrodt
Contact n/a
Is FDA regulated No
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04226131 - MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics N/A
Completed NCT04171414 - A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis Phase 3
Completed NCT02833350 - Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA) Phase 2
Completed NCT04255134 - Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN) Phase 4
Recruiting NCT05615246 - Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
Completed NCT03248518 - Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases N/A
Completed NCT03514355 - MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms N/A
Recruiting NCT06005220 - SBD121, a Synbiotic Medical Food for RA Management N/A
Recruiting NCT05451615 - Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis Phase 3
Completed NCT05054920 - Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis N/A
Completed NCT02037737 - Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting N/A
Recruiting NCT04079374 - Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel Phase 3
Completed NCT02504268 - Effects of Abatacept in Patients With Early Rheumatoid Arthritis Phase 3
Recruiting NCT05496855 - Remote Care in People With Rheumatoid Arthritis N/A
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Recruiting NCT06103773 - A Study of Single and Multiple Oral Doses of TollB-001 Phase 1
Recruiting NCT06031415 - Study of GS-0272 in Participants With Rheumatoid Arthritis Phase 1
Completed NCT05999266 - The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
Recruiting NCT05302934 - Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
Recruiting NCT04169100 - Novel Form of Acquired Long QT Syndrome Phase 4