Phase 2
N=121
Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury
NSAID-induced Gastroduodenal Injury · Ulcers · Rheumatoid Arthritis · Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT00597818 ↗Enrolled (actual)
121
Serious AEs
79.3%
Results posted
Dec 2019
Primary outcome: Primary: Number of Participants With Gastric Ulcers — 7; 5; 7; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cobiprostone (Drug); Placebo (Drug); Non-steroidal anti-inflammatory drug (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Sucampo Pharma Americas, LLC
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Gastric Ulcers |
7; 5; 7; 4 | — |
| SECONDARY Number of Participants With Duodenal and Gastroduodenal Ulcers |
1; 4; 1; 2 | — |
| SECONDARY Number of Participants With Gastric, Duodenal, and Gastroduodenal Ulcers |
7; 8; 8; 6 | — |
| SECONDARY Size of Ulcers/Erosions |
8.5; 4.7; 3.5; 2.6 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT00597818). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.