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

NCT06619847 | Completed Phase 2 FDA Drug

• 1 other identifier: VX24-993-101
• Study Type: interventional
• Target: 367
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Acute Pain

Outcome Measures

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)

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

Secondary Outcomes (7)

• 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

Study Arms (3)

VX-993

EXPERIMENTAL

Participants will be randomized to receive different dose levels of VX-993.

Drug: VX-993; Drug: Placebo (matched to HB/APAP)

Hydrocodone bitartrate/acetaminophen (HB/APAP)

ACTIVE COMPARATOR

Participants will be randomized to receive HB/APAP.

Drug: HB/APAP; Drug: Placebo (matched to VX-993)

Placebo

PLACEBO COMPARATOR

Participants will be randomized to receive placebo matched to VX-993 and HB/APAP.

Drug: Placebo (matched to VX-993); Drug: Placebo (matched to HB/APAP)

Interventions

VX-993 DRUG

Tablets for oral administration.

VX-993

HB/APAP DRUG

Capsules for oral administration.

Hydrocodone bitartrate/acetaminophen (HB/APAP)

Placebo (matched to VX-993) DRUG

Placebo matched to VX-993 for oral administration.

Hydrocodone bitartrate/acetaminophen (HB/APAP); Placebo

Placebo (matched to HB/APAP) DRUG

Placebo matched to HB/APAP for oral administration.

Placebo; VX-993

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (14)

Shoals Medical Trials Inc.

Sheffield, Alabama, 35660, United States

Location

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

Location

Trovare Clinical Research

Bakersfield, California, 93301, United States

Location

New Hope Research Development | Tarzana, CA

Tarzana, California, 91356, United States

Location

Clinical Pharmacology of Miami

Miami, Florida, 33172, United States

Location

ForCare Clinical Research

Tampa, Florida, 33613, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

BioBehavioral Research of Austin

Austin, Texas, 78759, United States

Location

HD Research LLC | First Surgical Hospital

Bellaire, Texas, 77401, United States

Location

HD Research LLC | Legent Orthopedic Hospital

Carrollton, Texas, 75006, United States

Location

Memorial Hermann Village

Houston, Texas, 77043, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78240, United States

Location

JBR Clinical Research

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 1, 2024
• Study Start: October 29, 2024
• Primary Completion: May 27, 2025
• Study Completion: May 27, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)