Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury

Phase 2

Completed

• Conditions: Ulcers; Osteoarthritis; NSAID-induced Gastroduodenal Injury; Rheumatoid Arthritis
• Interventions: Drug: Placebo; Drug: Cobiprostone; Drug: Non-steroidal anti-inflammatory drug

• Registration Number: NCT00597818
• Lead Sponsor: Sucampo Pharma Americas, LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2008-01-10
• Study First Submitted QC: 2008-01-17
• Study First Posted: 2008-01-18
• Primary Completion: 2009-04
• Study Completion: 2009-05
• Status Verified: 2018-03
• Results First Submitted: 2018-03-22
• Results First Submitted QC: 2019-12-10
• Last Update Submitted: 2019-12-10
• Results First Posted: 2019-12-26
• Last Update Posted: 2019-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants receive matching placebo capsules for 20 months
Placebo	Non-steroidal anti-inflammatory drug	Participants receive matching placebo capsules for 20 months
Cobiprostone QD	Non-steroidal anti-inflammatory drug	Participants receive 18 mcg cobiprostone once daily (QD) for 20 months
Cobiprostone BID	Non-steroidal anti-inflammatory drug	Participants receive 18 mcg cobiprostone twice daily (BID) for 20 months
Cobiprostone TID	Non-steroidal anti-inflammatory drug	Participants receive 18 mcg cobiprostone three times daily (TID) for 20 months
Cobiprostone QD	Cobiprostone	Participants receive 18 mcg cobiprostone once daily (QD) for 20 months
Cobiprostone TID	Cobiprostone	Participants receive 18 mcg cobiprostone three times daily (TID) for 20 months
Cobiprostone BID	Cobiprostone	Participants receive 18 mcg cobiprostone twice daily (BID) for 20 months

Primary Outcome Measures

Name	Time	Method
Number of Participants With Gastric Ulcers	at 20 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (19)

Gastroenterology Section at Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Dallas VA Research Corporation, Inc.; 🇺🇸 Dallas, Texas, United States

Gulf Coast Research, LLC; 🇺🇸 Baton Rouge, Louisiana, United States

University of Illinois Medical Center; 🇺🇸 Chicago, Illinois, United States

Facey Medical Foundation; 🇺🇸 Mission Hills, California, United States

Loma Linda University Physicians Medical Group; 🇺🇸 Loma Linda, California, United States

Gregory J. Wiener, MD PC; 🇺🇸 Chula Vista, California, United States

Sepulveda Ambulatory Care Center; 🇺🇸 Sepulveda, California, United States

Carl T Hayden VA Medical Center; 🇺🇸 Phoenix, Arizona, United States

Desert Oasis Healthcare; 🇺🇸 Palm Springs, California, United States

University Clinical Research, Inc.; 🇺🇸 Pembroke Pines, Florida, United States

Long Island Gastrointestinal Research Group; 🇺🇸 Great Neck, New York, United States

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

Oklahoma Founddation for Digestive Research; 🇺🇸 Oklahoma City, Oklahoma, United States

Research Associates of New York; 🇺🇸 New York, New York, United States

University of North Carolina Gastroenterology; 🇺🇸 Chapel Hill, North Carolina, United States

Altoona Center for Clinical Research; 🇺🇸 Duncansville, Pennsylvania, United States

Houston Institute for Clinical Research; 🇺🇸 Houston, Texas, United States

Digestive and Liver Disease Specialists; 🇺🇸 Norfolk, Virginia, United States