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
Overview
- Phase
- Phase 2
- Intervention
- Cobiprostone
- Conditions
- NSAID-induced Gastroduodenal Injury
- Sponsor
- Sucampo Pharma Americas, LLC
- Enrollment
- 121
- Locations
- 19
- Primary Endpoint
- Number of Participants With Gastric Ulcers
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Cobiprostone QD
Participants receive 18 mcg cobiprostone once daily (QD) for 20 months
Intervention: Cobiprostone
Cobiprostone TID
Participants receive 18 mcg cobiprostone three times daily (TID) for 20 months
Intervention: Non-steroidal anti-inflammatory drug
Placebo
Participants receive matching placebo capsules for 20 months
Intervention: Placebo
Placebo
Participants receive matching placebo capsules for 20 months
Intervention: Non-steroidal anti-inflammatory drug
Cobiprostone QD
Participants receive 18 mcg cobiprostone once daily (QD) for 20 months
Intervention: Non-steroidal anti-inflammatory drug
Cobiprostone BID
Participants receive 18 mcg cobiprostone twice daily (BID) for 20 months
Intervention: Cobiprostone
Cobiprostone BID
Participants receive 18 mcg cobiprostone twice daily (BID) for 20 months
Intervention: Non-steroidal anti-inflammatory drug
Cobiprostone TID
Participants receive 18 mcg cobiprostone three times daily (TID) for 20 months
Intervention: Cobiprostone
Outcomes
Primary Outcomes
Number of Participants With Gastric Ulcers
Time Frame: at 20 months
Secondary Outcomes
- 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)