Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension

NCT00737594 | Terminated Phase 2 Results DMC

• 1 other identifier: SPH0721
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Portal Hypertension

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) After Four (4) Weeks of Treatment

  4 weeks

Study Arms (3)

Placebo TID

PLACEBO COMPARATOR

Participants receive matching placebo capsules three times daily (TID)

Drug: Placebo

12 mcg TID

EXPERIMENTAL

Participants receive 12 mcg Cobiprostone TID

Drug: Cobiprostone

18 mcg TID

EXPERIMENTAL

Participants receive 18 mcg Cobiprostone TID

Drug: Cobiprostone

Interventions

Placebo DRUG

Matching placebo capsules for oral administration

Also known as: Matching placebo

Placebo TID

Cobiprostone DRUG

Cobiprostone capsules for oral administration

Also known as: Experimental product

12 mcg TID; 18 mcg TID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sucampo Pharma Americas, LLC: lead
• Sucampo Pharmaceuticals, Inc.: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Hypertension, Portal

Interventions

cobiprostone

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Limitations and Caveats

The trial terminated before data were collected.

Results Point of Contact

• Title: Medical Information Call Center
• Organization: Mallinckrodt Pharmaceuticals

clinicaltrials@mnk.com

800-556-3314

Study Officials

• Investigator

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2008
• First Posted: August 19, 2008
• Study Start: July 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: March 1, 2009
• Last Updated: November 18, 2019
• Results First Posted: March 16, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)