Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute 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 intravenous (IV) oliceridine administered as needed (PRN) compared with placebo in patients with moderate to severe acute postoperative pain after bunionectomy.

Official Title
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A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active-controlled Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy

Conditions
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Acute Pain

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


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 moderate to severe acute pain. 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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Accepts Healthy Volunteers

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment 1 Oliceridine<br> | Drug: Oliceridine<br> <br> |
| Experimental: Treatment 2 Oliceridine<br> | Drug: Oliceridine<br> <br> |
| Experimental: Treatment 3 Oliceridine<br> | Drug: Oliceridine<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |
| Active Comparator: Morphine<br> | Drug: Morphine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Who Respond to Study Medication at the 48-hr Numeric Pain Rating Scale (NRS) Assessment Compared to Placebo. |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Respiratory Safety Events Compared to Morphine. |  | 48 hours | 
| Duration of Respiratory Safety Events Compared to Morphine. |  | 48 hours | 
| Odds Ratio of Patients Who Respond to Study Medication at the 48-hr NRS Assessment Compared to Morphine. | Odds ratio of 48-hour responder analysis versus morphine. Number of patients who responded to study medication at the 48-hr NRS assessment is captured in the primary outcome measure. | 48 hours | 
| Number of Patients With Treatment-related Adverse Events. |  | 48 hours |