Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension

Portal Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00737594
• Other study ID #: SPH0721
• Status: Terminated
• Phase: Phase 2
• Start date: July 2008
• Est. completion date: March 2009

Study information

• Verified date: February 2016
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: March 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Portal
• Portal Hypertension

Intervention

Drug:
• Placebo
Matching placebo capsules for oral administration
• Cobiprostone
Cobiprostone capsules for oral administration

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Sucampo Pharma Americas, LLC	Sucampo Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) After Four (4) Weeks of Treatment		4 weeks