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

NCT06619847
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Phase
Phase 2
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Recruitment status
Completed
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Participants
367
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Lead sponsor
Vertex Pharmaceuticals Incorporated
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Start date
2024-10-29
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Number of sites
14
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Summary
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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Short title
A Study Evaluating Efficacy and Safety of VX-993 for Acute Pain After a Bunionectomy
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Official 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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2025-05-27
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First posted
2024-10-01
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Registry last updated
2026-05-28
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Primary completion date
2025-05-27
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Start date
2024-10-29
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Actual participants
367
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Participants
367
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
14
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Registry sponsor category
Industry
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Lead sponsor
Vertex Pharmaceuticals Incorporated
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06619847
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ClinicalTrials.gov ID
NCT06619847
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

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

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

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

    Timeframe: At 48 Hours After the First Dose of Study Drug

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

    Timeframe: At 48 Hours After the First Dose of Study Drug

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

    Timeframe: At 48 Hours After the First Dose of Study Drug

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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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)

    Timeframe: Day 1 up to Day 19

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

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.

Sources for eligibility
clinicaltrials.gov

  • Shoals Medical Trials Inc.Sheffield, United States
  • Arizona Research CenterPhoenix, United States
  • Woodland International Research GroupLittle Rock, United States
  • Trovare Clinical ResearchBakersfield, United States
  • New Hope Research Development | Tarzana, CATarzana, United States
  • Clinical Pharmacology of MiamiMiami, United States
  • ForCare Clinical ResearchTampa, United States
  • Atlanta Center for Medical ResearchAtlanta, United States
  • BioBehavioral Research of AustinAustin, United States
  • HD Research LLC | First Surgical HospitalBellaire, United States
  • HD Research LLC | Legent Orthopedic HospitalCarrollton, United States
  • Memorial Hermann VillageHouston, United States
  • Endeavor Clinical TrialsSan Antonio, United States
  • JBR Clinical ResearchSalt Lake City, United States
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Targets (4)