A Study of TRV130 for the Treatment of Pain After Bunionectomy

Acute Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02100748
• Other study ID #: CP130-2001
• Status: Completed
• Phase: Phase 2
• Start date: April 2014
• Est. completion date: October 2014

Study information

• Verified date: September 2020
• Source: Trevena Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 333
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Has undergone primary, unilateral, first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures.

• Experiences a pain intensity rating of = 4 on an 11 point NRS

• Able to provide written informed consent before any study procedure.

Exclusion Criteria:

• ASA Physical Status Classification System classification of P3 or worse

• Has surgical or post-surgical complications.

• Has clinically significant medical conditions or history of such conditions that may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs.

• Has previously participated in another TRV130 clinical study.

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• TRV130
TRV130 1 - 4 mg will be administered every 4 hours
• Morphine
Morphine 4 mg will be administered every 4 hours
• Placebo
Placebo will be administered every 4 hours

Locations

Country	Name	City	State
United States	Premier Research	Austin	Texas
United States	Chesapeake Research Group	Pasadena	Maryland
United States	Premier Research	Phoenix	Arizona
United States	Jean Brown Research	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Trevena Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time Weighted Average (TWA) Change From Baseline in Pain Score Over 48 Hours Between TRV130 and Placebo	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.	48 hours