drugset / Trial / NCT02815709

Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy

NCT02815709 ↗

Phase 3 Completed 418 enrolled Trevena Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine administered as needed (PRN) compared with placebo in patients with moderate to severe acute postoperative pain after bunionectomy.

Timeline

Start
2016-05
Primary completion
2016-12
Completion
2017-01

Outcome

Met primary endpoint

release “Results of APOLLO-1 (bunionectomy) All three oliceridine regimens (0.1 mg, 0.35 mg, and 0.5 mg on-demand doses) achieved the primary endpoint” trevena.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Morphine Other / unclassified — —
Subject Oliceridine Other / unclassified — Intravenous

Indications

No indication recorded.