A Study of TRV130 for the Treatment of Pain After Abdominoplasty

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-08-31

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 following abdominoplasty.

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Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TRV130

Group Type EXPERIMENTAL

TRV130

Intervention Type DRUG

Rescue: Ibuprofen, oxycodone

Morphine

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

Rescue: Ibuprofen, oxycodone

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Rescue: Ibuprofen, oxycodone

Interventions

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TRV130

Rescue: Ibuprofen, oxycodone

Intervention Type DRUG

Morphine

Rescue: Ibuprofen, oxycodone

Intervention Type DRUG

Placebo

Rescue: Ibuprofen, oxycodone

Intervention Type DRUG

Other Intervention Names

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Morphine sulphate Dextrose 5% in water, D5W

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No