A Study of TRV130 for the Treatment of Pain After Bunionectomy

The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain after bunionectomy. The results section also includes data from the morphine arms.

• TRV130 (Drug): TRV130 1 - 4 mg will be administered every 4 hours
• Morphine (Drug), also known as Morphine sulphate: Morphine 4 mg will be administered every 4 hours
• Placebo (Drug), also known as Dextrose 5% in water, D5W: Placebo will be administered every 4 hours

Primary outcomes

• Time Weighted Average (TWA) Change From Baseline in Pain Score Over 48 Hours Between TRV130 and Placebo [48 hours]: Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 48 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (48 hours) to yield values on the 0-10 NPRS.

Sex: All, ages: 18 Years to 75 Years

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.

Participant flow

Outcome results

• Time Weighted Average (TWA) Change From Baseline in Pain Score Over 48 Hours Between TRV130 and Placebo (Primary), Mean, score on a scale: Part A - TRV130 1 mg -3.1 +/- 2.11; Part A - TRV130 2 mg -3.1 +/- 2.25; Part A - TRV130 3 mg -2.6 +/- 1.82; Part A - TRV130 4 mg -3.3 +/- 1.51; Part A - Morphine -4.1 +/- 2.02; Part A - Placebo -3.2 +/- 1.79; Part B - TRV130 0.5 mg -3.0 +/- 2.36; Part B - TRV130 1 mg -2.9 +/- 2.64; Part B - TRV130 2 mg -3.7 +/- 2.10; Part B - TRV130 3 mg -5.0 +/- 2.14; Part B - Placebo -2.8 +/- 2.12; Part B - Morphine -4.0 +/- 1.89

Adverse events

Other adverse events by term

• Franck Skobieranda, MD, Study director, Trevena Inc.