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Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension

This study has been completed.
Sponsor:
Information provided by:
Sucampo Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00737594
First received: August 15, 2008
Last updated: July 10, 2009
Last verified: July 2009
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 9
Study Start Date: July 2008
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo
0 mcg capsules three times daily (TID)
Experimental: 2
Cobiprostone 36 mcg
 Drug: Cobiprostone
12 mcg cobiprostone (capsules) three times daily (TID)
Experimental: 3
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

Locations
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Sucampo Pharmaceuticals, Inc.
Investigators
Principal Investigator: Don Rockey, MD University of Texas Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Clinical Trial Manager, Sucampo Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00737594     History of Changes
Other Study ID Numbers: SPH0721
Study First Received: August 15, 2008
Last Updated: July 10, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Hypertension, Portal
Vascular Diseases
 Cardiovascular Diseases
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 21, 2013