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Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT00597818•Sucampo Pharma Americas, LLC

View on ClinicalTrials.gov

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

Age

40 - 70 years

Sex

ALL

Healthy Volunteers

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.

Locations (19)

Carl T Hayden VA Medical Center

Phoenix, Arizona, United States

Gregory J. Wiener, MD PC

Chula Vista, California, United States

Loma Linda University Physicians Medical Group

Loma Linda, California, United States

Facey Medical Foundation

Mission Hills, California, United States

Desert Oasis Healthcare

Palm Springs, California, United States

Sepulveda Ambulatory Care Center

Sepulveda, California, United States

University Clinical Research, Inc.

Pembroke Pines, Florida, United States

University of Illinois Medical Center

Chicago, Illinois, United States

Gulf Coast Research, LLC

Baton Rouge, Louisiana, United States

Boston Medical Center

Boston, Massachusetts, United States

Key Dates

Start Date

August 1, 2007

Primary Completion Date

April 1, 2009

Completion Date

May 1, 2009

Last Updated

December 26, 2019

Enrollment

121

ACTUAL participants

Conditions

NSAID-induced Gastroduodenal InjuryUlcersRheumatoid ArthritisOsteoarthritis

Interventions

Cobiprostone

DRUG

Placebo

DRUG

Non-steroidal anti-inflammatory drug

DRUG

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

NCT07484243

Rheumatoid Arthritis (RA)Rheumatoid Arthritis-Associated Interstitial Lung Disease+1 more

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RECRUITINGPHASE1

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

NCT06647069

Systemic Lupus Erythematosus (SLE)Rheumatoid Arthritis (RA)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 26, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury

Inclusion Criteria

Exclusion Criteria

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

Targeted Remotely-delivered Anti-inflammatory Interventions With Exercise for Rheumatoid Arthritis

Plant-Based Diet for Patients With Rheumatoid Arthritis

An Ascending Dose Study of PIT565 in Participants With Rheumatoid Arthritis

A Phase II Trial of SHR-3045 Injection in Patients With Rheumatoid Arthritis