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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 )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Portal Hypertension
Interventions Drug: Placebo
Drug: Cobiprostone
Enrollment 9
Recruitment Details  
Pre-assignment Details 9 participants were recruited, but the study terminated before data were collected
Arm/Group Title Placebo 12 mcg TID 18 mcg TID
Hide Arm/Group Description Placebo: 0 mcg capsules three times daily (TID)

Cobiprostone 36 mcg

Cobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID)

Cobiprostone 54 mcg

Cobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID)

Period Title: Overall Study
Started 0 0 0
Completed 0 0 0
Not Completed 0 0 0
Arm/Group Title Placebo 12 mcg TID 18 mcg TID Total
Hide Arm/Group Description Placebo: 0 mcg capsules three times daily (TID)

Cobiprostone 36 mcg

Cobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID)

Cobiprostone 54 mcg

Cobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID)

Total of all reporting groups
Overall Number of Baseline Participants 0 0 0 0
Hide Baseline Analysis Population Description
The study terminated before data were collected
Age, Categorical  
Number Analyzed 0 participants 0 participants 0 participants 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male  
Number Analyzed 0 participants 0 participants 0 participants 0 participants
Female
Male
Region of Enrollment  
Unit of measure:  Participants
United States Number Analyzed 0 participants 0 participants 0 participants 0 participants
1.Primary Outcome
Title Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) After Four (4) Weeks of Treatment
Hide Description [Not Specified]
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early, data were not collected.
Arm/Group Title Placebo 12 mcg TID 18 mcg TID
Hide Arm/Group Description:
Placebo: 0 mcg capsules three times daily (TID)

Cobiprostone 36 mcg

Cobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID)

Cobiprostone 54 mcg

Cobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID)

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame The trial terminated before data were collected
Adverse Event Reporting Description The trial terminated before data were collected
 
Arm/Group Title Placebo 12 mcg TID 18 mcg TID
Hide Arm/Group Description Placebo: 0 mcg capsules three times daily (TID)

Cobiprostone 36 mcg

Cobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID)

Cobiprostone 54 mcg

Cobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID)

All-Cause Mortality
Placebo 12 mcg TID 18 mcg TID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo 12 mcg TID 18 mcg TID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo 12 mcg TID 18 mcg TID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
The trial terminated before data were collected.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Information Call Center
Organization: Mallinckrodt Pharmaceuticals
Phone: 800-556-3314 ext 5
EMail: clinicaltrials@mnk.com
Layout table for additonal information
Responsible Party: Mallinckrodt ( Sucampo Pharma Americas, LLC )
ClinicalTrials.gov Identifier: NCT00737594    
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: November 18, 2019