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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.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00737594
First Posted: August 19, 2008
Last Update Posted: March 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sucampo Pharma Americas, LLC ( Sucampo Pharmaceuticals, Inc. )
  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
Intervention Model: Parallel Assignment
Masking: Double (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 ( Sucampo Pharmaceuticals, Inc. ):

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
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sucampo Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00737594     History of Changes
Other Study ID Numbers: SPH0721
First Submitted: August 15, 2008
First Posted: August 19, 2008
Results First Submitted: February 16, 2016
Results First Posted: March 16, 2016
Last Update Posted: March 16, 2016
Last Verified: February 2016

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