VX-993 for Acute Pain After Bunionectomy
VX-993
+ Placebo (matched to HB/APAP)
+ HB/APAP
Neurologic Manifestations+2
+ Pain
+ Signs and Symptoms
Treatment Study
Summary
Study start date: October 29, 2024
Actual date on which the first participant was enrolled.This study is focused on understanding how effective and safe a new medication, VX-993, is in treating acute pain following a bunionectomy, which is a surgical procedure to correct a bunion on the foot. The study targets individuals who have recently undergone this surgery and are experiencing pain. By investigating this new treatment, researchers hope to find a better way to manage post-surgical pain, which can improve recovery experiences and patient comfort. Participants in this study will receive either the VX-993 medication or a placebo, which is an inactive substance, to compare their effects on pain relief. The medication is given in varying doses to determine the most effective and safest amount. Researchers will monitor how well the drug alleviates pain and any side effects that may occur. This approach helps to ensure a comprehensive understanding of the treatment's benefits and potential risks.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.367 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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 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) within the last 2 years * A known or clinically suspected active infection with human immunodeficiency virus or hepatitis B or C viruses 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 Other protocol defined inclusion/exclusion criteria may apply.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorGroup III
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 14 locations
Shoals Medical Trials Inc.
Sheffield, United StatesArizona Research Center
Phoenix, United StatesWoodland International Research Group
Little Rock, United States