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Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension
This study is currently recruiting participants.
Verified by Sucampo Pharmaceuticals, Inc., August 2008
Sponsored by: Sucampo Pharmaceuticals, Inc.
Information provided by: Sucampo Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00737594
  Purpose

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.


Condition Intervention Phase
Portal Hypertension
Drug: Placebo
Drug: Cobiprostone
Phase II

MedlinePlus related topics: High Blood Pressure
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Placebo-Controlled, Double-Blinded Study of the Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension

Further study details as provided by Sucampo Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Change from baseline in hepatic venous pressure gradient (HVPG) [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acute changes from baseline in HVPG following administration of a single oral dose of cobiprostone [ Time Frame: 30 and 60 minutes post dose ] [ Designated as safety issue: No ]
  • Change from baseline in total bilirubin [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in ascites grade [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Child-Pugh score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Proportion of treatment responders [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in quality of life [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 33
Study Start Date: July 2008
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Placebo Comparator Drug: Placebo
0 mcg capsules three times daily (TID)
2: Experimental
Cobiprostone 36 mcg
Drug: Cobiprostone
12 mcg cobiprostone (capsules) three times daily (TID)
3: Experimental
Cobiprostone 54 mcg
Drug: Cobiprostone
18 mcg cobiprostone (capsules) three times daily (TID)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is >= 18 years of age.
  • Patient has clinical and/or pathological diagnosis of intra-hepatic portal hypertension.
  • Patient has clinical diagnosis of cirrhosis.
  • Patient has undergone variceal banding.

Exclusion Criteria:

  • Patient has a Child-Pugh score >12.
  • Patient has portal hypertension resulting from hepatic vein obstruction, portal vein occlusion, schistosomiasis, portal vein thrombosis, splenic vein thrombosis, or Budd-Chiari syndrome.
  • Variceal banding procedure was performed within 1 month of the screening visit.
  • Patient has active or recurrent variceal bleeding, or has had variceal bleeding within the 12 weeks prior to screening.
  • Patient is unwilling to discontinue use of vasoactive drugs from the screening visit through the end of the study.
  • Patient has hepatocellular carcinoma that is being medically treated or is advanced.
  • Patient has impaired renal function (i.e., serum creatinine concentration >1.8 mg/dl)
  • Patient has a history of liver transplant, or is expected to receive a liver transplant during the study period.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00737594

Contacts
Contact: Portal Hypertension Study PHstudy@sucampo.com

Locations
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Portal Hypertension Study         PHstudy@sucampo.com    
Sponsors and Collaborators
Sucampo Pharmaceuticals, Inc.
Investigators
Principal Investigator: Don Rockey, MD University of Texas Southwestern Medical Center
  More Information

Responsible Party: Sucampo Pharmaceuticals, Inc. ( Clinical Trial Manager )
Study ID Numbers: SPH0721
Study First Received: August 15, 2008
Last Updated: August 15, 2008
ClinicalTrials.gov Identifier: NCT00737594  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Liver Diseases
Digestive System Diseases
Vascular Diseases
Hypertension, Portal
Portal hypertension
Hypertension

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009