Evaluation of Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty

Trial completed

Phase 3

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

ClinicalTrials.gov Identifier

NCT05558410

Eligibility criteria

Sex

Age

18 Years - 80 Years

Phase

Key inclusion criteria

Before Surgery
Participant scheduled to undergo a standard ("full") abdominoplasty procedure
After Surgery
Participant is lucid and able to follow commands and able to swallow oral medications
All analgesic guidelines were followed during and after the abdominoplasty
Abdominoplasty procedure duration less than or equal to (≤3) hours

Key exclusion criteria

Before Surgery
Prior history of abdominoplasty
History of Intra-abdominal and/or pelvic surgery that resulted into complications
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 non standard abdominoplasty, collateral procedures during the abdominoplasty or any surgical complications during the abdominoplasty
Participant had a medical complication during the abdominoplasty that, in the opinion of the investigator, should preclude randomization

Other protocol defined Inclusion/Exclusion criteria may apply.

Trial details

Condition

Acute Pain

Study duration

October 2022 - September 2023

Study type

Interventional

Intervention/Treatment

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

Estimated enrollment

1118

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Recruiting

Shoals Medical Trials Inc.

Sheffield Alabama 35660 United States