A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty

Vertex Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Acute Pain

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05034952

VX21-548-102

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 an abdominoplasty.

Enrollment: 303 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 an abdominoplasty without collateral procedures

• After Surgery:

  • Participant is lucid and able to follow commands
  • All analgesic guidelines were followed during and after the abdominoplasty
  • Abdominoplasty procedure duration <=3 hours without collateral procedures (for example., liposuction)

Key Exclusion Criteria

• Before Surgery:

  • Prior history of abdominoplasty, intra-abdominal and/or pelvic surgery
  • History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
  • Any prior surgery within 1 month before the first study drug

• After Surgery:

  • Participant had medical complications during the abdominoplasty that, in the opinion of the investigator, should preclude randomization
  • Participant had collateral procedures during the abdominoplasty

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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303 participants in 4 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 mg / APAP 325 milligrams (mg) every 6 hours (q6h) for 2 days.

Treatment:

Drug: HB/APAP

VX-548: Low Dose

Experimental group

Description:

Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg every 12 hours (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