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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01953081 | A Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of a Single Dose of Intravenous TD-8954 Compared With Metoclopramide in Critically Ill Patients With Enteral Feeding Intolerance | PHASE1 | COMPLETED | 13 | — | — | Jan 1, 2014 | Oct 1, 2014 | Feb 18, 2020 | 1 | Australia |
the number of subjects reporting adverse events by treatment group
Number of subjects with retention less than 13% at 180 minutes after dosing.
| Arm | Type | Description |
|---|---|---|
| TD-8954 | EXPERIMENTAL | TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours |
| Metoclopramide | ACTIVE_COMPARATOR | Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline |
| Name | Type | Description |
|---|---|---|
| TD-8954 | DRUG | - |
| Metoclopramide | DRUG | - |
Inclusion Criteria: * Intubated, on mechanical ventilation, and anticipated to remain on mechanical ventilation for 2 days after enrollment into the study * Receiving enteral feeding and assessed to have developed EFI, as defined by a GRV measurement ≥250 mL within the 24 hours before randomization...