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Completed

NCT Number: NCT06619847

A Study Evaluating 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.

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shoals Medical Trials Inc., Sheffield, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VX-993

Drug

Tablets for oral administration.

HB/APAP

Drug

Capsules for oral administration.

Placebo (matched to VX-993)

Drug

Placebo matched to VX-993 for oral administration.

Placebo (matched to HB/APAP)

Drug

Placebo matched to HB/APAP for oral administration.

Primary outcomes

  1. 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

  1. 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

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

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

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

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

  4. 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

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 1, 2024
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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