NCT02100748

A Study of TRV130 for the Treatment of Pain After Bunionectomy

A Phase 2, Multicenter, Randomized, Double-blind, Multiple-dose, Adaptive, Placebo- and Active-controlled Study of TRV130 for the Treatment of Acute Postoperative Pain After Bunionectomy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 333 (actual)
• Sponsor: Trevena Inc. · Industry
• Sex: All
• Age: 18 Years – 75 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 after bunionectomy.

Detailed description

The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain after bunionectomy. The results section also includes data from the morphine arms.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	TRV130	TRV130 1 - 4 mg will be administered every 4 hours
DRUG	Morphine	Morphine 4 mg will be administered every 4 hours
DRUG	Placebo	Placebo will be administered every 4 hours

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-04-01
• Last updated: 2020-09-16
• Results posted: 2020-09-16

Locations

4 sites across 1 country: United States