A Study of TRV130 for the Treatment of Pain After Abdominoplasty

Phase 2

Completed

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

• Registration Number: NCT02335294
• 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 following abdominoplasty.

Detailed Description

The primary objective is to evaluate the analgesic efficacy of intravenous (IV) TRV130 administered via patient controlled analgesia device (PCA) compared with placebo administered via PCA in patients with moderate to severe, acute postoperative pain following abdominoplasty.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-01-07
• Study First Submitted QC: 2015-01-08
• Study First Posted: 2015-01-09
• Primary Completion: 2015-07
• Study Completion: 2015-08
• Disposition First Submitted: 2017-09-15
• Disposition First Submitted QC: 2018-07-23
• Disposition First Posted: 2018-07-26
• Results First Submitted: 2020-08-21
• 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: 200

Inclusion Criteria

• >=18 and <=65 years of age.
• Plans to undergo an abdominoplasty procedure with no additional collateral procedures.
• Is able to understand and comply with the procedures and study requirements, and 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Morphine	Morphine	-
TRV130	TRV130	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Placebo	24-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 24 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (24 hours) to yield values on the 0-10 NPRS.

Secondary Outcome Measures

Name	Time	Method
Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Morphine	24-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 24 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (24 hours) to yield values on the 0-10 NPRS.