Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy

Acute Pain Clinical Trial

Official title:

A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05553366
• Other study ID #: VX22-548-104
• Status: Completed
• Phase: Phase 3
• Start date: October 3, 2022
• Est. completion date: December 15, 2023

Study information

• Verified date: March 2024
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of VX-548 for acute pain after a bunionectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1075
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Key Inclusion Criteria:

• Before Surgery

• Participants scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., Austin procedure) and internal fixation under regional anesthesia (Mayo and popliteal sciatic block)

• After Surgery

• Participant is lucid and able to follow commands

• All analgesic guidelines were followed during and after the bunionectomy

Key Exclusion Criteria:

• Before Surgery

• Prior history of bunionectomy or or other foot surgery on the index foot; or bunionectomy on the opposite foot

• History of cardiac dysrhythmias within the last 2 years requiring anti-arrhythmia treatment(s)

• Any prior surgery within 1 month before the first study drug dose

• After Surgery

• Participant had a type 3 deformity requiring a base wedge osteotomy, concomitant surgery such as hammertoe repair; or experienced medical complications during the bunionectomy

• Participant had a medical complication during the bunionectomy that, in the opinion of the investigator, should preclude randomization

Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• VX-548
Tablets for oral administration.
• HB/APAP
Capsules for oral administration.
• Placebo (matched to VX-548)
Placebo matched to VX-548 for oral administration.
• Placebo (matched to HB/APAP)
Placebo matched to HB/APAP for oral administration.

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials	Anaheim	California
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Trovare Clinical Research	Bakersfield	California
United States	HD Research LLC | First Surgical Hospital	Bellaire	Texas
United States	HD Research LLC | Legent Orthopedic Hospital	Carrollton	Texas
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Clinical Pharmacology of Miami	Hialeah	Florida
United States	HD Research LLC | Houston Heights Hospital	Houston	Texas
United States	Center for Orthopaedic Reconstruction and Excellence	Jenks	Oklahoma
United States	Woodland International Research Group	Little Rock	Arkansas
United States	Futuro Clinical Trials	McAllen	Texas
United States	Arizona Research Center	Phoenix	Arizona
United States	JBR Clinical Research	Salt Lake City	Utah
United States	Endeavor Clinical Trials	San Antonio	Texas
United States	Pacific Research Network Inc	San Diego	California
United States	Shoals Medical Trials Inc.	Sheffield	Alabama
United States	ForCare Clinical Research	Tampa	Florida
United States	New Hope Research Development	Tarzana	California
United States	Houston Physicians Hospital	Webster	Texas
United States	New Hope Research Development	West Covina	California
United States	Kansas Spine and Specialty Hospital	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-weighted Sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48) Compared to Placebo		Baseline to 48 Hours
Secondary	SPID48 Compared to HB/APAP		Baseline to 48 Hours
Secondary	Time to Greater than or Equal to (=)2-Point Reduction in NPRS from Baseline Compared to Placebo		Baseline to 48 Hours
Secondary	Time to =1-Point Reduction in NPRS from Baseline Compared to Placebo		Baseline to 48 Hours
Secondary	Proportion of Participants Reporting Good or Excellent on the Patient Global Assessment (PGA) Compared to Placebo		At 48 Hours
Secondary	Incidence of Vomiting or Nausea Compared to HB/APAP		Baseline to Day 17
Secondary	Time-weighted SPID as Recorded on the NPRS from 0 to 24 hours (SPID24) Compared to Placebo		Baseline to 24 hours
Secondary	Time to First Use of Rescue Medication Compared to Placebo		Baseline to 48 hours
Secondary	Proportion of Participants using Rescue Medication Compared to Placebo		Baseline to 48 hours
Secondary	Total Rescue Medication Usage Compared to Placebo		Baseline to 48 hours
Secondary	Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)		Baseline to Day 17