A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy

Vertex Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Acute Pain

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04977336

VX21-548-101

Details and patient eligibility

About

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

Enrollment: 274 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 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 other foot surgery on the index foot
  • History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
  • Any prior surgery within 1 month before the first study drug

• 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 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: Quadruple Blind

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274 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received placebo matched to VX-548 and Hydrocodone bitartrate/acetaminophen (HB/APAP) for 2 days.

Treatment:

Drug: Placebo (matched to VX-548)

Drug: Placebo (matched to HB/APAP)

HB/APAP

Active Comparator group

Description:

Participants received HB 5 milligrams (mg)/ APAP 325 mg every 6 hours (q6h) for 2 days.

Treatment:

Drug: HB/APAP

VX-548: Low Dose

Experimental group

Description:

Participants received VX-548 20 mg as first dose, followed by VX-548 10 mg tablet every 12 hours (q12h) for 2 days.

Treatment:

Drug: VX-548

VX-548: Mid Dose

Experimental group

Description:

Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg q12h for 2 days.

Treatment:

Drug: VX-548

VX-548: High Dose

Experimental group

Description:

Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.

Treatment:

Drug: VX-548