NCT00597818

Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Sucampo Pharma Americas, LLC · Industry
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NSAID-induced Gastroduodenal Injury
• Ulcers
• Rheumatoid Arthritis
• Osteoarthritis

Interventions

Type	Name	Description
DRUG	Cobiprostone	18 mcg cobiprostone capsules for oral administration
DRUG	Placebo	Matching placebo capsules for oral administration
DRUG	Non-steroidal anti-inflammatory drug	Any marketed non-steroidal anti-inflammatory drug used by the participants as standard care.

Timeline

• Start date: 2007-08-01
• Primary completion: 2009-04-01
• Completion: 2009-05-01
• First posted: 2008-01-18
• Last updated: 2019-12-26
• Results posted: 2019-12-26

Locations

19 sites across 1 country: United States