A Study Evaluating Efficacy and Safety of VX-993 for Acute Pain After a Bunionectomy

Phase 2CompletedNCT06619847

Vertex Pharmaceuticals Incorporated367 enrolled

Overview

The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of VX-993 in treating acute pain after a bunionectomy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

367

Conditions

Acute Pain

Interventions

VX-993DRUG

Tablets for oral administration.

HB/APAPDRUG

Capsules for oral administration.

Placebo (matched to VX-993)DRUG

Placebo matched to VX-993 for oral administration.

Placebo (matched to HB/APAP)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 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) within the last 2 years * A known or clinically suspected active infection with human immunodeficiency virus or hepatitis B or C viruses 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 Other protocol defined inclusion/exclusion criteria may apply.

Locations (14)

Shoals Medical Trials Inc.

Sheffield, Alabama, United States

Arizona Research Center

Phoenix, Arizona, United States

Woodland International Research Group

Outcomes

Primary Outcomes

Time-weighted Sum of Pain Intensity Difference (SPID) as Recorded on the Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48)

Time frame: From 0 to 48 Hours After the First Dose of Study Drug

Secondary Outcomes

Proportion of Participants With Greater Than or Equal To (>=) 30 Percent (%) Reduction in NPRS at 48 Hours

Time frame: At 48 Hours After the First Dose of Study Drug

Proportion of Participants With >=50% Reduction in NPRS at 48 Hours

Time frame: At 48 Hours After the First Dose of Study Drug

Proportion of Participants With >=70% Reduction in NPRS at 48 Hours

Time frame: At 48 Hours After the First Dose of Study Drug

Maximum Observed Plasma Concentration (Cmax) of VX-993 and its Metabolite

Time frame: Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug

Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-993 and its Metabolite

Time frame: Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug

Time to Reach Maximum Observed Plasma Concentration (Tmax) of VX-993 and its Metabolite

Time frame: Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug

Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: Day 1 up to Day 19

Data from ClinicalTrials.gov

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