NCT03206749

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

A Phase 2 Randomized, Double-blind, Placebo-controlled, 3-arm, Parallel-design Study of the Efficacy and Safety of VX-150 for Acute Pain Following Bunionectomy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 243 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	VX-150	Participants received VX-150 1500 milligram (mg) as first dose, followed by VX-150 750 mg dose every 12 hours (q12h) for 2 days.
DRUG	HB/APAP	Participants received HB 5 mg/APAP 325 mg every 6 hours (q6h) for 2 days.
DRUG	Placebo	Participants received placebo matched to VX-150 and HB/APAP for 2 days.

Timeline

• Start date: 2017-06-29
• Primary completion: 2017-12-01
• Completion: 2017-12-08
• First posted: 2017-07-02
• Last updated: 2021-02-03
• Results posted: 2021-02-03

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study