Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01915901 | PeptoBismol® Use to Reduce Gastrointestinal Events in Healthy Volunteers Receiving DMF [Tecfidera®] Twice Daily | PHASE1 | COMPLETED | 175 | — | — | Aug 1, 2013 | Dec 1, 2013 | Mar 3, 2014 | 3 | United States |
| Arm | Type | Description |
|---|---|---|
| bismuth subsalicylate (Pepto-Bismol®) + DMF | EXPERIMENTAL | Subjects will receive dimethyl fumarate (DMF) and bismuth subsalicylate (Pepto-Bismol®). |
| Placebo + DMF | EXPERIMENTAL | Subjects will receive dimethyl fumarate (DMF) and placebo. |
| Name | Type | Description |
|---|---|---|
| bismuth subsalicylate (Pepto-Bismol®) | DRUG | 524 mg bismuth subsalicylate twice a day (BID) |
| matching placebo (bismuth subsalicylate) | DRUG | placebo twice a day (BID) |
| dimethyl fumarate (DMF) | DRUG | dimethyl fumarate (DMF) twice a day (BID) |
Key Inclusion Criteria: * Must be in good health as determined by the Principal Investigator (PI) based on medical history and Screening evaluations (clinical laboratory evaluations, 12-lead electrocardiogram (ECG), and vital signs; see below for specific exclusion criteria). * Must have a body mas...