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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02656875 | A Open-label Study to Evaluate the Safety of TRV130 in Patients With Acute Pain | PHASE3 | COMPLETED | 768 | — | — | Dec 1, 2015 | Aug 1, 2017 | Sep 24, 2020 | 10 | United States |
| NCT02100748 | A Study of TRV130 for the Treatment of Pain After Bunionectomy | PHASE2 | COMPLETED | 333 | — | — | Apr 1, 2014 | Oct 1, 2014 | Sep 16, 2020 | 4 | United States |
Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 48 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (48 hours) to yield values on the 0-10 NPRS.
| Arm | Type | Description |
|---|---|---|
| TRV130 | EXPERIMENTAL | For clinician-administered bolus dosing, TRV130 initial dose is administered and supplemental dosing is available, if clinically indicated. Subsequent doses may be administered every 1 to 3 hours as needed. For PCA dosing, the TRV130 regimen consists of a loading dose, a demand dose, and a lockout interval. |
| TRV130 1 mg | EXPERIMENTAL | TRV130 1 mg IV Q4H x 48 h |
| TRV130 2 mg | EXPERIMENTAL | TRV130 2 mg IV Q4H x 48 h |
| TRV130 3 mg | EXPERIMENTAL | TRV130 3 mg IV Q4H x 48 h |
| TRV130 4 mg | EXPERIMENTAL | TRV130 4 mg IV Q4H x 48 h |
| Morphine | ACTIVE_COMPARATOR | Morphine 4 mg IV Q4H x 48 h |
| Placebo | PLACEBO_COMPARATOR | Placebo (D5W) IV Q4H x 48 h |
| Name | Type | Description |
|---|---|---|
| TRV130 | DRUG | - |
| Morphine | DRUG | Morphine 4 mg will be administered every 4 hours |
| Placebo | DRUG | Placebo will be administered every 4 hours |
Inclusion Criteria include: * Moderate to severe acute pain for which parenteral opioid therapy is warranted * Able to understand and comply with the procedures and study requirements, and to provide written informed consent before any study procedure. Exclusion Criteria include: * Clinically sig...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Fresenius Medical Care AG Sponsored ADR | FMS | 2 | PHASE3 | Dialysis |
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| CalciMedica, Inc. | CALC | 1 | PHASE2 | Auxora |
| Talphera, Inc. | TLPH | 1 | NA | Undisclosed |
| SeaStar Medical Holding Corporation | ICU | 2 | — | Undisclosed |
| Collegium Pharmaceutical, Inc. | COLL | 1 | — | Flozin |