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Failure to enroll a suitable number of qualified subjects.
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| Name | Class |
|---|---|
| Sucampo Pharmaceuticals, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo TID | Placebo Comparator | Participants receive matching placebo capsules three times daily (TID) |
|
| 12 mcg TID | Experimental | Participants receive 12 mcg Cobiprostone TID |
|
| 18 mcg TID | Experimental | Participants receive 18 mcg Cobiprostone TID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Matching placebo capsules for oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) After Four (4) Weeks of Treatment | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Investigator | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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9 participants were recruited, but the study terminated before data were collected
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo: 0 mcg capsules three times daily (TID) |
| FG001 | 12 mcg TID | Cobiprostone 36 mcg Cobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID) |
| FG002 | 18 mcg TID | Cobiprostone 54 mcg Cobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The study terminated before data were collected
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo: 0 mcg capsules three times daily (TID) |
| BG001 | 12 mcg TID | Cobiprostone 36 mcg Cobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) After Four (4) Weeks of Treatment | Study terminated early, data were not collected. | Posted | 4 weeks |
|
The trial terminated before data were collected
The trial terminated before data were collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo: 0 mcg capsules three times daily (TID) |
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The trial terminated before data were collected.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Call Center | Mallinckrodt Pharmaceuticals | 800-556-3314 | 5 | clinicaltrials@mnk.com |
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| ID | Term |
|---|---|
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C581134 | cobiprostone |
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| Cobiprostone | Drug | Cobiprostone capsules for oral administration |
|
|
| BG002 | 18 mcg TID | Cobiprostone 54 mcg Cobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID) |
| BG003 | Total | Total of all reporting groups |
|
| Sex: Female, Male |
|
| Region of Enrollment | participants |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 12 mcg TID | Cobiprostone 36 mcg Cobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID) | 0 | 0 | 0 | 0 |
| EG002 | 18 mcg TID | Cobiprostone 54 mcg Cobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID) | 0 | 0 | 0 | 0 |
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