Clinical trial

A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-dose Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty

Name

VX21-548-102

Description

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

Trial arms

Trial start

2021-08-30

Estimated PCD

2021-12-05

Trial end

2021-12-21

Status

Completed

Phase

Early phase I

Treatment

VX-548

Tablets for oral administration.

Arms:

VX-548

HB/APAP

Capsules for oral administration.

Arms:

Hydrocodone bitartrate/ acetaminophen (HB/APAP)

Placebo (matched to VX-548)

Placebo matched to VX-548 for oral administration.

Arms:

Hydrocodone bitartrate/ acetaminophen (HB/APAP), Placebo

Placebo (matched to HB/APAP)

Placebo matched to HB/APAP for oral administration.

Arms:

Placebo, VX-548

Size

303

Primary endpoint

Time-weighted sum of the Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) at Rest 0 to 48 Hours (SPIDr0-48) After the First Dose of Study Drug

0 to 48 Hours After the First Dose of Study Drug

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 303, 'type': 'ACTUAL'}}

Updated at

2022-12-07

1 organization

3 products

1 indication

Organization

Vertex Pharmaceuticals

Product

Indication

Product

Product