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 ]

Study terminated early, data was not analyzed.


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