A Study of TRV130 for the Treatment of Pain After Bunionectomy

Trevena Inc.333 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

333

Conditions

Acute Pain

Interventions

TRV130DRUG

TRV130 1 - 4 mg will be administered every 4 hours

MorphineDRUG

Morphine 4 mg will be administered every 4 hours

PlaceboDRUG

Placebo will be administered every 4 hours

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (4)

Premier Research

Phoenix, Arizona, United States

Chesapeake Research Group

Pasadena, Maryland, United States

Premier Research

Austin, Texas, United States

Jean Brown Research

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

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.

Time frame: 48 hours

Data from ClinicalTrials.gov

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