Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Abdominoplasty

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 pain after abdominoplasty.

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 Abdominoplasty

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 abdominoplasty 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: Treatment 4 Placebo<br> | Drug: Placebo<br> <br> |
| Active Comparator: Treatment 5 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 24-hr Numeric Pain Rating Scale (NPRS) Assessment Compared to Placebo. | The NPRS is an 11-point scale from 0-10 where 0 = no pain and 10 = the most intense pain imaginable. A patient was a responder if: their final time-weighted Sum of Pain Intensity Difference (SPID)-24 corresponded to a ≥30% improvement without rescue pain medication during the Randomized Treatment Period, without early discontinuation of study medication for any reason, and without reaching the study medication dosing limit. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Respiratory Safety Events Compared to Morphine. | Respiratory Safety Events were defined as a clinically relevant worsening of respiratory status. | 24 hours | 
| Duration of Respiratory Events Compared to Morphine. | Respiratory Safety Events were defined as a clinically relevant worsening of respiratory status. | 24 hours | 
| Odds Ratio of Patients Who Respond to Study Medication at the 24-hr NPRS Assessment Compared to Morphine. | Odds ratio of 24-hour responder analysis versus morphine. Number of patients who responded to study medication at the 24-hr NPRS assessment is captured in the primary outcome measure. | 24 hours | 
| Number of Patients With Treatment-related Adverse Events Compared to Placebo and Compared to Morphine. |  | 24 hours |