Trial Outcomes & Findings for Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension (NCT NCT00737594)
NCT ID: NCT00737594
Last Updated: 2019-11-18
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
4 weeks
Results posted on
2019-11-18
Participant Flow
9 participants were recruited, but the study terminated before data were collected
Participant milestones
| Measure |
Placebo
Placebo: 0 mcg capsules three times daily (TID)
|
12 mcg TID
Cobiprostone 36 mcg
Cobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID)
|
18 mcg TID
Cobiprostone 54 mcg
Cobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID)
|
|---|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 4 weeksPopulation: Study terminated early, data were not collected.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
12 mcg TID
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
18 mcg TID
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Medical Information Call Center
Mallinckrodt Pharmaceuticals
Phone: 800-556-3314
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place