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

Vertex Pharmaceuticals Incorporated303 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

303

Conditions

Acute Pain

Interventions

VX-548DRUG

Tablets for oral administration.

HB/APAPDRUG

Capsules for oral administration.

Placebo (matched to VX-548)DRUG

Placebo matched to VX-548 for oral administration.

Placebo (matched to HB/APAP)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (7)

Arizona Research Center

Phoenix, Arizona, United States

Lotus Clinical Research

Pasadena, California, United States

Chesapeake Research Group

Pasadena, Maryland, United States

Midwest Clinical Research Center

Dayton, Ohio, United States

Outcomes

Primary Outcomes

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

SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the pain intensity score at given post-dose time points from the baseline pain intensity scores (using pain rating score range: 0= no pain to 10= worst possible pain). SPIDr0-48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).

Time frame: 0 to 48 Hours After First Dose of Study Drug

Secondary Outcomes

Time-weighted SPID as Recorded on an NPRS at Rest 0 to 24 Hours (SPIDr0-24) After the First Dose of Study Drug

SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the pain intensity score at given post-dose time points from the baseline pain intensity scores (using pain rating score range: 0= no pain to 10= worst possible pain). SPIDr0-24 was calculated from 0 to 24 hours and the score range was -240 (worst score) to 240 (best score).

Time frame: 0 to 24 Hours After First Dose of Study Drug

Percentage of Participants With at Least 30 Percent (%),Reduction in NPRS (at Rest) at 48 Hours After the First Dose of Study Drug

Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The percentage of participants with at least 30% reduction from baseline in NPRS at 48 hours after the first dose of VX-548 or placebo were reported.

Time frame: From Baseline At 48 Hours After First Dose of Study Drug

Percentage of Participants With at Least 50% Reduction in NPRS (at Rest) at 48 Hours After the First Dose of Study Drug

Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0=no pain and 10=worst imaginable pain. The percentage of participants with at least 50% reduction from baseline in NPRS at 48 hours after the first dose of VX-548, HB/APAP, or placebo were reported.

Data from ClinicalTrials.gov

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