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Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension

This study has been terminated.
(Failure to enroll a suitable number of qualified subjects.)
Information provided by (Responsible Party):
Sucampo Pharma Americas, LLC ( Sucampo Pharmaceuticals, Inc. ) Identifier:
First received: August 15, 2008
Last updated: February 16, 2016
Last verified: February 2016
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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

Further study details as provided by Sucampo Pharma Americas, LLC:

Primary Outcome Measures:
  • 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.

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: Placebo
Drug: Placebo
0 mcg capsules three times daily (TID)
Other Name: No other names
Experimental: 12 mcg TID
Cobiprostone 36 mcg
Drug: Cobiprostone
12 mcg cobiprostone (capsules) three times daily (TID)
Other Name: No other names
Experimental: 18 mcg TID
Cobiprostone 54 mcg
Drug: Cobiprostone
18 mcg cobiprostone (capsules) three times daily (TID)
Other Name: No other names


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00737594

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

Responsible Party: Sucampo Pharmaceuticals, Inc. Identifier: NCT00737594     History of Changes
Other Study ID Numbers: SPH0721
Study First Received: August 15, 2008
Results First Received: February 16, 2016
Last Updated: February 16, 2016

Additional relevant MeSH terms:
Hypertension, Portal
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases processed this record on April 28, 2017