At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 121 enrolled
Drug / intervention
Cobiprostone +2 moredrug
Likely dose
Cobiprostone 18 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Cobiprostone, Placebo, and 1 other intervention for NSAID-induced Gastroduodenal Injury and 3 related conditions. Completed, enrolled 121 participants across 19 sites.
Detailed 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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2007
First PostedJan 2008
Primary CompletionApr 2009
Study CompletionMay 2009
TodayJul 2026
First PostedJan 18, 2008
Enrollment StartAug 1, 2007
Primary CompletionApr 1, 2009
Study CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 18.5 years ago
Interventions
Cobiprostonedrug
18 mcg cobiprostone capsules for oral administration
Placebodrug
Matching placebo capsules for oral administration
Non-steroidal anti-inflammatory drugdrug
Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care.