A Study of TRV130 for the Treatment of Pain After Bunionectomy (NCT02100748) | Clinical Trial Compass
CompletedPhase 2
A Study of TRV130 for the Treatment of Pain After Bunionectomy
United States333 participantsStarted 2014-04
Plain-language summary
The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain after bunionectomy.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Time Weighted Average (TWA) Change From Baseline in Pain Score Over 48 Hours Between TRV130 and Placebo