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Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension

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.
 
ClinicalTrials.gov Identifier: NCT00737594
Recruitment Status : Terminated (Failure to enroll a suitable number of qualified subjects.)
First Posted : August 19, 2008
Results First Posted : March 16, 2016
Last Update Posted : November 18, 2019
Sponsor:
Collaborator:
Sucampo Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Mallinckrodt ( Sucampo Pharma Americas, LLC )

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.

Condition or disease Intervention/treatment Phase
Portal Hypertension Drug: Placebo Drug: Cobiprostone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
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
Study Start Date : July 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo TID
Participants receive matching placebo capsules three times daily (TID)
Drug: Placebo
Matching placebo capsules for oral administration
Other Name: Matching placebo

Experimental: 12 mcg TID
Participants receive 12 mcg Cobiprostone TID
Drug: Cobiprostone
Cobiprostone capsules for oral administration
Other Name: Experimental product

Experimental: 18 mcg TID
Participants receive 18 mcg Cobiprostone TID
Drug: Cobiprostone
Cobiprostone capsules for oral administration
Other Name: Experimental product




Primary Outcome Measures :
  1. Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) After Four (4) Weeks of Treatment [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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
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United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Sucampo Pharma Americas, LLC
Sucampo Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Investigator University of Texas Southwestern Medical Center

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Responsible Party: Sucampo Pharma Americas, LLC
ClinicalTrials.gov Identifier: NCT00737594    
Other Study ID Numbers: SPH0721
First Posted: August 19, 2008    Key Record Dates
Results First Posted: March 16, 2016
Last Update Posted: November 18, 2019
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hypertension, Portal
Hypertension
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases