A Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy

Summary

This is a Phase 2 randomized, double-blind, placebo-controlled, 3-arm, parallel design study to evaluate the efficacy and safety of VX-150 in treating acute pain following bunionectomy.

Timeline

Start

2017-06-29

Primary completion

2017-12-01

Completion

2017-12-08

Outcome

Met primary endpoint

registry LEAST_SQUARES_MEAN VX-150: 36.14 (Standard Error 5.15) units on a scale NCT03206749 ↗

registry analysis (superiority test); VX-150 vs Placebo; p <0.0001; Least Squares (LS) Mean Difference 29.50 (95% CI 16.61 to 42.40); ANCOVA NCT03206749 ↗

release “The study met its primary endpoint, showing a statistically significant improvement in SPID24 for those treated with VX-150 compared to placebo.” vrtx.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Acetaminophen	Small molecule	325 mg	—
Comparator	Hydrocodone bitartrate	Unknown	5 mg	—
Subject	VX-150	Unknown	750 mg	—

Indications

No indication recorded.