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

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.

Conditions

Acute Pain

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Acute Pain
Intervention / Treatment

-

Contacts and Locations

Phoenix

Arizona Research Center, Phoenix, Arizona, United States, 85053

Little Rock

Woodland International Research Group, Little Rock, Arkansas, United States, 72211

Tampa

ForCare Clinical Research, Tampa, Florida, United States, 33613

Atlanta

Atlanta Center for Medical Research, Atlanta, Georgia, United States, 30331

Austin

BioBehavioral Research of Austin, Austin, Texas, United States, 78759

Bellaire

HD Research LLC | First Surgical Hospital, Bellaire, Texas, United States, 77401

Carrollton

HD Research LLC | Legent Orthopedic Hospital, Carrollton, Texas, United States, 75006

Houston

Memorial Hermann Village, Houston, Texas, United States, 77043

San Antonio

Endeavor Clinical Trials, San Antonio, Texas, United States, 78240

Salt Lake City

JBR Clinical Research, Salt Lake City, Utah, United States, 84107

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vertex Pharmaceuticals Incorporated,

Study Record Dates

2025-10