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Sponsored by: |
Sucampo Pharmaceuticals, Inc. |
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Information provided by: | Sucampo Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00737594 |
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 | Intervention | Phase |
---|---|---|
Portal Hypertension |
Drug: Placebo Drug: Cobiprostone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Placebo-Controlled, Double-Blinded Study of the Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension |
Estimated Enrollment: | 33 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator |
Drug: Placebo
0 mcg capsules three times daily (TID)
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2: Experimental
Cobiprostone 36 mcg
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Drug: Cobiprostone
12 mcg cobiprostone (capsules) three times daily (TID)
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3: Experimental
Cobiprostone 54 mcg
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Drug: Cobiprostone
18 mcg cobiprostone (capsules) three times daily (TID)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Portal Hypertension Study | PHstudy@sucampo.com |
United States, Texas | |
University of Texas Southwestern Medical Center | Recruiting |
Dallas, Texas, United States, 75390 | |
Contact: Portal Hypertension Study PHstudy@sucampo.com |
Principal Investigator: | Don Rockey, MD | University of Texas Southwestern Medical Center |
Responsible Party: | Sucampo Pharmaceuticals, Inc. ( Clinical Trial Manager ) |
Study ID Numbers: | SPH0721 |
Study First Received: | August 15, 2008 |
Last Updated: | August 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00737594 |
Health Authority: | United States: Food and Drug Administration |
Liver Diseases Digestive System Diseases Vascular Diseases |
Hypertension, Portal Portal hypertension Hypertension |
Cardiovascular Diseases |