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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01333540 | A Study to Assess the Safety, Tolerability and Clinical Activity of TD-1211 in Patients With Opioid-Induced Constipation | PHASE2 | COMPLETED | 69 | — | — | May 1, 2011 | Jun 1, 2012 | Jan 25, 2021 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Active | EXPERIMENTAL | Escalating Doses of TD-1211 |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| TD-1211 | DRUG | Escalating doses |
| Placebo | DRUG | Placebo once daily |
Inclusion Criteria: * Males and females between 18 and 65 years of age, inclusive * Subjects with documented OIC on stable opioid regimen * Willingness to stop all laxatives throughout run-in and treatment period Exclusion Criteria: * Any clinically significant findings in subjects with OIC * Hav...