Clinical Trial: Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension
Brief Summary: The primary purpose of this study is to determine the efficacy and safety of cobiprostone (at two dose levels) as compared to placebo for lowering portal hypertension.
Detailed Summary:
Sponsor: Sucampo Pharmaceuticals, Inc.
Current Primary Outcome: Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) After Four (4) Weeks of Treatment [ Time Frame: 4 weeks ]
Original Primary Outcome: Change from baseline in hepatic venous pressure gradient (HVPG) [ Time Frame: 4 weeks ]
Current Secondary Outcome:
Original Secondary Outcome:
- Acute changes from baseline in HVPG following administration of a single oral dose of cobiprostone [ Time Frame: 30 and 60 minutes post dose ]
- Change from baseline in total bilirubin [ Time Frame: 4 weeks ]
- Change from baseline in ascites grade [ Time Frame: 4 weeks ]
- Change from baseline in Child-Pugh score [ Time Frame: 4 weeks ]
- Proportion of treatment responders [ Time Frame: 4 weeks ]
- Change from baseline in quality of life [ Time Frame: 4 weeks ]
Information By: Sucampo Pharma Americas, LLC
Dates:
Date Received: August 15, 2008
Date Started: July 2008
Date Completion:
Last Updated: February 16, 2016
Last Verified: February 2016