Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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NSAID-induced Gastroduodenal Injury, Ulcers, Rheumatoid Arthritis, Osteoarthritis

Intervention / Treatment
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* Drug: Cobiprostone
* Drug: Placebo
* Drug: Non-steroidal anti-inflammatory drug


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Participants receive matching placebo capsules for 20 months | Drug: Placebo<br>* Matching placebo capsules for oral administration<br>* Other names: Matching Placebo;Drug: Non-steroidal anti-inflammatory drug<br>* Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care.<br>* Other names: Standard Care;|
| Experimental: Cobiprostone QD<br>Participants receive 18 mcg cobiprostone once daily (QD) for 20 months | Drug: Cobiprostone<br>* 18 mcg cobiprostone capsules for oral administration<br>* Other names: RU-8811;Drug: Non-steroidal anti-inflammatory drug<br>* Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care.<br>* Other names: Standard Care;|
| Experimental: Cobiprostone BID<br>Participants receive 18 mcg cobiprostone twice daily (BID) for 20 months | Drug: Cobiprostone<br>* 18 mcg cobiprostone capsules for oral administration<br>* Other names: RU-8811;Drug: Non-steroidal anti-inflammatory drug<br>* Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care.<br>* Other names: Standard Care;|
| Experimental: Cobiprostone TID<br>Participants receive 18 mcg cobiprostone three times daily (TID) for 20 months | Drug: Cobiprostone<br>* 18 mcg cobiprostone capsules for oral administration<br>* Other names: RU-8811;Drug: Non-steroidal anti-inflammatory drug<br>* Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care.<br>* Other names: Standard Care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Gastric Ulcers |  | at 20 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |