A Study of TRV130 for the Treatment of Pain After Bunionectomy

Phase 2

Completed

• Conditions: Acute Pain
• Interventions: Drug: TRV130; Drug: Placebo; Drug: Morphine

• Registration Number: NCT02100748
• Lead Sponsor: Trevena Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2014-03-23
• Study First Submitted QC: 2014-03-27
• Study Start: 2014-04
• Study First Posted: 2014-04-01
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Disposition First Submitted: 2017-07-07
• Disposition First Submitted QC: 2017-07-07
• Disposition First Posted: 2017-07-11
• Results First Submitted: 2020-08-20
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-11
• Last Update Submitted: 2020-09-11
• Results First Posted: 2020-09-16
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 333

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TRV130 1 mg	TRV130	TRV130 1 mg IV Q4H x 48 h
TRV130 2 mg	TRV130	TRV130 2 mg IV Q4H x 48 h
TRV130 3 mg	TRV130	TRV130 3 mg IV Q4H x 48 h
TRV130 4 mg	TRV130	TRV130 4 mg IV Q4H x 48 h
Placebo	Placebo	Placebo (D5W) IV Q4H x 48 h
Morphine	Morphine	Morphine 4 mg IV Q4H x 48 h

Primary Outcome Measures

Name	Time	Method
Time Weighted Average (TWA) Change From Baseline in Pain Score Over 48 Hours Between TRV130 and Placebo	48 hours	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.

Trial Locations

Locations (3)

Premier Research; 🇺🇸 Austin, Texas, United States

Chesapeake Research Group; 🇺🇸 Pasadena, Maryland, United States

Jean Brown Research; 🇺🇸 Salt Lake City, Utah, United States