Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension

October 31, 2019 updated by: Sucampo Pharma Americas, LLC

A Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • Matching placebo
Experimental: 12 mcg TID
Participants receive 12 mcg Cobiprostone TID
Drug: Cobiprostone
Cobiprostone capsules for oral administration
Other Names:
  • Experimental product
Experimental: 18 mcg TID
Participants receive 18 mcg Cobiprostone TID
Drug: Cobiprostone
Cobiprostone capsules for oral administration
Other Names:
  • Experimental product

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) After Four (4) Weeks of Treatment
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sucampo Pharma Americas, LLC

Collaborators

Sucampo Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Investigator, University of Texas Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

August 15, 2008

First Submitted That Met QC Criteria

August 15, 2008

First Posted (Estimate)

August 19, 2008

Study Record Updates

Last Update Posted (Actual)

November 18, 2019

Last Update Submitted That Met QC Criteria

October 31, 2019

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPH0721

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe