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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02493036 | A Single-Dose, Open-Label, Study to Evaluate the Sustainability of the Effects of SYN-010 in Patients With IBS-C | PHASE2 | COMPLETED | 54 | — | — | Oct 1, 2015 | Dec 1, 2015 | Nov 27, 2018 | 11 | United States |
| NCT02495623 | A Study of the Effect of SYN-010 on Subjects With IBS-C | PHASE2 | COMPLETED | 63 | — | — | Jun 1, 2015 | Nov 1, 2015 | Nov 27, 2018 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| High Dose SYN-010 | EXPERIMENTAL | 42-mg SYN-010 |
| Low Dose | ACTIVE_COMPARATOR | 21 mg SYN-010 |
| High Dose | ACTIVE_COMPARATOR | 42 mg SYN-010 |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| SYN-010 | DRUG | - |
| SYN-010 21 mg | DRUG | - |
| SYN-010 42 mg | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Subject has completed Study SB-2-010-001. * Subject must be willing to abstain from or discontinue the use of any laxatives and any prescription and over-the-counter medications or supplements intended to treat constipation from the time of Screening to the end of the study, e...