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

A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Evaluating the Efficacy and Safety of VX-993 for Acute Pain After a Bunionectomy

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 Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Drug: Placebo (matched to HB/APAP); Drug: HB/APAP; Drug: VX-993; Drug: Placebo (matched to VX-993)

• Study Type: Interventional
• Enrollment (Actual): 367
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Sheffield, Alabama, United States, 35660
      • Shoals Medical Trials Inc.
  • Arizona
    • Phoenix, Arizona, United States, 85053
      • Arizona Research Center
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Woodland International Research Group
  • California
    • Bakersfield, California, United States, 93301
      • Trovare Clinical Research
    • Tarzana, California, United States, 91356
      • New Hope Research Development | Tarzana, CA
  • Florida
    • Miami, Florida, United States, 33172
      • Clinical Pharmacology of Miami
    • Tampa, Florida, United States, 33613
      • Forcare Clinical Research
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research
  • Texas
    • Austin, Texas, United States, 78759
      • BioBehavioral Research of Austin
    • Bellaire, Texas, United States, 77401
      • HD Research LLC | First Surgical Hospital
    • Carrollton, Texas, United States, 75006
      • HD Research LLC | Legent Orthopedic Hospital
    • Houston, Texas, United States, 77043
      • Memorial Hermann Village
    • San Antonio, Texas, United States, 78240
      • Endeavor Clinical Trials
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • JBR Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hydrocodone bitartrate/acetaminophen (HB/APAP); Participants will be randomized to receive HB/APAP.	Drug: HB/APAP; Capsules for oral administration.; Drug: Placebo (matched to VX-993); Placebo matched to VX-993 for oral administration.
Experimental: VX-993; Participants will be randomized to receive different dose levels of VX-993.	Drug: Placebo (matched to HB/APAP); Placebo matched to HB/APAP for oral administration.; Drug: VX-993; Tablets for oral administration.
Placebo Comparator: Placebo; Participants will be randomized to receive placebo matched to VX-993 and HB/APAP	Drug: Placebo (matched to HB/APAP); Placebo matched to HB/APAP for oral administration.; Drug: Placebo (matched to VX-993); Placebo matched to VX-993 for oral administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time-weighted Sum of Pain Intensity Difference (SPID) as Recorded on the Numeric Pain Rating Scale (NPRS) From 0 to 48 Hours (SPID48)	From 0 to 48 Hours After the First Dose of Study Drug

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of Participants With Greater Than or Equal To (>=) 30 Percent (%) Reduction in NPRS at 48 Hours	At 48 Hours After the First Dose of Study Drug
Proportion of Participants With >=50% Reduction in NPRS at 48 Hours	At 48 Hours After the First Dose of Study Drug
Proportion of Participants With >=70% Reduction in NPRS at 48 Hours	At 48 Hours After the First Dose of Study Drug
Maximum Observed Plasma Concentration (Cmax) of VX-993 and its Metabolite	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	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)	Day 1 up to Day 19
Time to Reach Maximum Observed Plasma Concentration (Tmax) of VX-993 and its Metabolite	Pre-dose to 12 Hours and 24 to 36 Hours After the First Dose of Study Drug

Collaborators and Investigators

• Sponsor: Vertex Pharmaceuticals Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2024
• Primary Completion (Actual): May 27, 2025
• Study Completion (Actual): May 27, 2025

Study Registration Dates

• First Submitted: September 27, 2024
• First Submitted That Met QC Criteria: September 27, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Acute Pain; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Acetaminophen
• Other Study ID Numbers: VX24-993-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes