A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy

Acute Pain Clinical Trial

Official title:

A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04977336
• Other study ID #: VX21-548-101
• Status: Completed
• Phase: Phase 2
• Start date: July 19, 2021
• Est. completion date: March 4, 2022

Study information

• Verified date: February 2023
• 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 doses in treating acute pain after a bunionectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: March 4, 2022
• Est. primary completion date: February 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Key Inclusion Criteria:

• Before Surgery:

• Participant 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 other foot surgery on the index foot

• History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)

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

• After Surgery:

• Participant had a Type 3 deformity requiring a base wedge osteotomy or concomitant surgery such as hammertoe repair, or had medical complications 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	First Surgical Hospital	Bellaire	Texas
United States	Legent Orthopedic Hospital	Carrollton	Texas
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Chesapeake Research Group	Pasadena	Maryland
United States	Lotus Clinical Research	Pasadena	California
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	Shoals Medical Trials Inc.	Sheffield	Alabama
United States	New Hope Research Development	Tarzana	California

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 Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 48 Hours (SPID48) After the First Dose of Study Drug		0 to 48 Hours After the First Dose of Study Drug
Secondary	Time-weighted SPID as Recorded on a NPRS 0 to 24 Hours (SPID24) After the First Dose of Study Drug		0 to 24 Hours After the First Dose of Study Drug
Secondary	Proportions of Participants With >=30 Percent (%), >=50%, and >=70% Reduction in NPRS at 48 Hours After the First Dose of Study Drug		At 48 Hours After the First Dose of Study Drug
Secondary	Maximum Observed Plasma Concentration (Cmax) of VX-548		Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) of VX-548		Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug
Secondary	Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-548		Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug
Secondary	Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		Day 1 up to Day 18