NCT02335294

A Study of TRV130 for the Treatment of Pain After Abdominoplasty

A Phase 2, Randomized, Double-Blind, Placebo- and Active-controlled Study of TRV130 for the Treatment of Acute Postoperative Pain Following Abdominoplasty

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Trevena Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain following abdominoplasty.

Detailed description

The primary objective is to evaluate the analgesic efficacy of intravenous (IV) TRV130 administered via patient controlled analgesia device (PCA) compared with placebo administered via PCA in patients with moderate to severe, acute postoperative pain following abdominoplasty.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	TRV130	Rescue: Ibuprofen, oxycodone
DRUG	Morphine	Rescue: Ibuprofen, oxycodone
DRUG	Placebo	Rescue: Ibuprofen, oxycodone

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-07-01
• Completion: 2015-08-01
• First posted: 2015-01-09
• Last updated: 2020-09-16
• Results posted: 2020-09-16

Locations

2 sites across 1 country: United States