Evaluation of Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy

Vertex Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Acute Pain

Treatments: Drug: Placebo (matched to VX-548); Drug: HB/APAP; Drug: VX-548; Drug: Placebo (matched to HB/APAP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05553366

VX22-548-104

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of VX-548 for acute pain after a bunionectomy.

Enrollment: 1,075 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Before Surgery

  • Participants scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., Austin procedure) and internal fixation under regional anesthesia (Mayo and popliteal sciatic 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 or other foot surgery on the index foot; or bunionectomy on the opposite foot
  • History of cardiac dysrhythmias within the last 2 years requiring anti-arrhythmia treatment(s)
  • Any prior surgery within 1 month before the first study drug dose

• After Surgery

  • Participant had a type 3 deformity requiring a base wedge osteotomy, concomitant surgery such as hammertoe repair; or experienced medical complications during the bunionectomy
  • Participant had a medical complication during the bunionectomy that, in the opinion of the investigator, should preclude randomization

Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,075 participants in 3 patient groups, including a placebo group

VX-548

Experimental group

Description:

Participants will be randomized to receive VX-548.

Treatment:

Drug: Placebo (matched to HB/APAP)

Drug: VX-548

Hydrocodone bitartrate/acetaminophen (HB/APAP)

Active Comparator group

Description:

Participants will be randomized to receive HB/APAP.

Treatment:

Drug: HB/APAP

Drug: Placebo (matched to VX-548)

Placebo

Placebo Comparator group

Description:

Participants will be randomized to receive placebo matched to VX-548 and HB/APAP.

Treatment:

Drug: Placebo (matched to HB/APAP)

Drug: Placebo (matched to VX-548)