A Study of TRV130 for the Treatment of Pain After Abdominoplasty
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 7/27/2018 |
| Start Date: | December 2014 |
| End Date: | August 2015 |
A Phase 2, Randomized, Double-Blind, Placebo- and Active-controlled Study of TRV130 for the Treatment of Acute Postoperative Pain Following Abdominoplasty
The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with
placebo in patients with acute postoperative pain following abdominoplasty.
placebo in patients with acute postoperative pain following abdominoplasty.
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.
administered via patient controlled analgesia device (PCA) compared with placebo administered
via PCA in patients with moderate to severe, acute postoperative pain following
abdominoplasty.
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.
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