A Study of TRV130 for the Treatment of Pain After Abdominoplasty

Trevena

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Drug: Placebo; Drug: Morphine; Drug: TRV130

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02335294

CP130-2002

Details and patient eligibility

About

The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain following abdominoplasty.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 3 patient groups, including a placebo group

TRV130

Experimental group

Treatment:

Drug: TRV130

Morphine

Active Comparator group

Treatment:

Drug: Morphine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo