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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Sucampo Pharma Americas, LLC
- Enrollment
- 121
- Locations
- 19
- Primary Endpoint
- Number of Participants With Gastric Ulcers
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 (Drug)
Cobiprostone TID
Participants receive 18 mcg cobiprostone three times daily (TID) for 20 months
Intervention: Non-steroidal anti-inflammatory drug (Drug)
Placebo
Participants receive matching placebo capsules for 20 months
Intervention: Placebo (Drug)
Placebo
Participants receive matching placebo capsules for 20 months
Intervention: Non-steroidal anti-inflammatory drug (Drug)
Cobiprostone QD
Participants receive 18 mcg cobiprostone once daily (QD) for 20 months
Intervention: Non-steroidal anti-inflammatory drug (Drug)
Cobiprostone BID
Participants receive 18 mcg cobiprostone twice daily (BID) for 20 months
Intervention: Cobiprostone (Drug)
Cobiprostone BID
Participants receive 18 mcg cobiprostone twice daily (BID) for 20 months
Intervention: Non-steroidal anti-inflammatory drug (Drug)
Cobiprostone TID
Participants receive 18 mcg cobiprostone three times daily (TID) for 20 months
Intervention: Cobiprostone (Drug)
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)