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

Vertex Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Acute Pain

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06619847

VX24-993-101

Details and patient eligibility

About

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

Enrollment: 355 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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355 participants in 3 patient groups, including a placebo group

VX-993

Experimental group

Description:

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

Treatment:

Drug: Placebo (matched to HB/APAP)

Drug: VX-993

Hydrocodone bitartrate/acetaminophen (HB/APAP)

Active Comparator group

Description:

Participants will be randomized to receive HB/APAP.

Treatment:

Drug: Placebo (matched to VX-993)

Drug: HB/APAP

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo (matched to VX-993)

Drug: Placebo (matched to HB/APAP)