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

NCT02820324 ↗

Phase 3 Completed 407 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 pain after abdominoplasty.

Timeline

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

Publications

Singla NK, Skobieranda F, Soergel DG, Salamea M, Burt DA, Demitrack MA, Viscusi ER. APOLLO-2: A Randomized, Placebo and Active-Controlled Phase III Study Investigating Oliceridine (TRV130), a G Protein-Biased Ligand at the mu-Opioid Receptor, for Management of Moderate to Severe Acute Pain Following Abdominoplasty. Pain Pract. 2019 Sep;19(7):715-731. doi: 10.1111/papr.12801. Epub 2019 Jun 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Morphine	Other / unclassified	1 mg	—
Subject	Oliceridine	Other / unclassified	0.1 mg	Intravenous
Subject	Oliceridine	Other / unclassified	0.35 mg	Intravenous
Subject	Oliceridine	Other / unclassified	0.5 mg	Intravenous

Indications

No indication recorded.