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

Vertex Pharmaceuticals Incorporated274 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

274

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 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.

Locations (12)

Shoals Medical Trials Inc.

Sheffield, Alabama, United States

Arizona Research Center

Phoenix, Arizona, United States

Anaheim Clinical Trials

Anaheim, California, United States

Outcomes

Primary Outcomes

Time-Weighted Sum of Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 48 Hours (SPID48) 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). SPID48 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 a NPRS 0 to 24 Hours (SPID24) 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). SPID24 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 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, HB/APAP or placebo was 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 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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