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A Study Evaluating Efficacy and Safety of VX-993 for Acute Pain After a Bunionectomy

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Conditions

Acute Pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of VX-993 in treating acute pain after a bunionectomy.

Official Title

A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Evaluating the Efficacy and Safety of VX-993 for Acute Pain After a Bunionectomy

Quick Facts

Study Start:2024-10-29
Study Completion:2025-05-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06619847

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Participant is lucid and able to follow commands
  3. * All analgesic guidelines were followed during and after the bunionectomy
  1. * Prior history of bunionectomy or other foot surgery on the index foot
  2. * History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s) within the last 2 years
  3. * A known or clinically suspected active infection with human immunodeficiency virus or hepatitis B or C viruses
  4. * 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

Contacts and Locations

Study Locations (Sites)

Shoals Medical Trials Inc.
Sheffield, Alabama, 35660
United States
Arizona Research Center
Phoenix, Arizona, 85053
United States
Woodland International Research Group
Little Rock, Arkansas, 72211
United States
Trovare Clinical Research
Bakersfield, California, 93301
United States
New Hope Research Development | Tarzana, CA
Tarzana, California, 91356
United States
Clinical Pharmacology of Miami
Miami, Florida, 33172
United States
ForCare Clinical Research
Tampa, Florida, 33613
United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
United States
BioBehavioral Research of Austin
Austin, Texas, 78759
United States
HD Research LLC | First Surgical Hospital
Bellaire, Texas, 77401
United States
HD Research LLC | Legent Orthopedic Hospital
Carrollton, Texas, 75006
United States
Memorial Hermann Village
Houston, Texas, 77043
United States
Endeavor Clinical Trials
San Antonio, Texas, 78240
United States
JBR Clinical Research
Salt Lake City, Utah, 84107
United States

Collaborators and Investigators

Sponsor: Vertex Pharmaceuticals Incorporated

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-29
Study Completion Date2025-05-27

Study Record Updates

Study Start Date2024-10-29
Study Completion Date2025-05-27

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Pain