Phase 2
Completed N=333
A Study of TRV130 for the Treatment of Pain After Bunionectomy
Source: ClinicalTrials.gov NCT02100748 ↗Enrolled (actual)
333
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Time Weighted Average (TWA) Change From Baseline in Pain Score Over 48 Hours Between TRV130 and Placebo — -3.1; -3.1; -2.6; -3.3 score on a scale
Summary
The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain after bunionectomy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Weighted Average (TWA) Change From Baseline in Pain Score Over 48 Hours Between TRV130 and Placebo |
-3.1; -3.1; -2.6; -3.3; -4.1; -3.2 | — |
Eligibility Criteria
Inclusion Criteria
- Has undergone primary, unilateral, first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures.
- Experiences a pain intensity rating of ≥ 4 on an 11 point NRS
- 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.
Data sourced from ClinicalTrials.gov (NCT02100748). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.