Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Abdominoplasty
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 5/10/2017 |
| Start Date: | May 2016 |
| End Date: | January 2017 |
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
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.
administered as needed (PRN) compared with placebo in patients with moderate to severe acute
pain after abdominoplasty.
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.
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