A Study of TRV130 for the Treatment of Pain After Bunionectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Acute Pain

Intervention / Treatment
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* Drug: TRV130
* Drug: Morphine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRV130 1 mg<br>TRV130 1 mg IV Q4H x 48 h | Drug: TRV130<br>* TRV130 1 - 4 mg will be administered every 4 hours<br>|
| Experimental: TRV130 2 mg<br>TRV130 2 mg IV Q4H x 48 h | Drug: TRV130<br>* TRV130 1 - 4 mg will be administered every 4 hours<br>|
| Experimental: TRV130 3 mg<br>TRV130 3 mg IV Q4H x 48 h | Drug: TRV130<br>* TRV130 1 - 4 mg will be administered every 4 hours<br>|
| Experimental: TRV130 4 mg<br>TRV130 4 mg IV Q4H x 48 h | Drug: TRV130<br>* TRV130 1 - 4 mg will be administered every 4 hours<br>|
| Active Comparator: Morphine<br>Morphine 4 mg IV Q4H x 48 h | Drug: Morphine<br>* Morphine 4 mg will be administered every 4 hours<br>* Other names: Morphine sulphate;|
| Placebo Comparator: Placebo<br>Placebo (D5W) IV Q4H x 48 h | Drug: Placebo<br>* Placebo will be administered every 4 hours<br>* Other names: D5W;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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moderate to severe acute pain, bunionectomy