A Single-arm Study to Evaluate Safety and Effectiveness of VX-548 for Acute Pain

Phase 3

Completed

• Conditions: Pain
• Interventions: Drug: VX-548

• Registration Number: NCT05661734
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of VX-548 in treating acute pain.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-14
• Study First Submitted QC: 2022-12-14
• Study First Posted: 2022-12-22
• Study Start: 2023-01-09
• Primary Completion: 2023-12-12
• Study Completion: 2023-12-12
• Disposition First Posted: 2024-03-20
• Status Verified: 2024-12
• Disposition First Submitted: 2024-12-09
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

Inclusion Criteria

• Body mass index (BMI) of greater than or equal to (≥) 18.0 to less than (<) 40.0 kilogram per meter square (kg/m^2)
• Non-surgical participants with pain of new origin (not related to a prior known condition) that is moderate or severe on the verbal categorical rating scale (VRS) and ≥4 on the numeric pain rating scale (NPRS)
• Surgical participants reporting pain at the surgical site that is moderate or severe on the VRS and ≥4 on the NPRS

Key

Exclusion Criteria

• Surgical participants:

  • History of previous surgery due to the same condition, except for procedures for which a previous surgery on the contra-lateral limb or organ is allowed
  • History of a prior surgical procedure in the same region of the body that resulted in any perioperative complications or that, in the opinion of the investigator or medical monitor, would preclude participation in the study

• History of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant

Other protocol defined Inclusion/Exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VX-548	VX-548	Participants will receive VX-548 every 12 hours (q12h) up to 14 days.

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Day 1 up to Day 28

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants Reporting Good, Very Good, or Excellent on a Patient Global Assessment (PGA)	Day 2 up to Day 14

Trial Locations

Locations (13)

Cypress Surgery Center; 🇺🇸 Wichita, Kansas, United States

Mart Medical Research Group LLC; 🇺🇸 South Miami, Florida, United States

Center for Orthopaedic Reconstruction and Excellence; 🇺🇸 Jenks, Oklahoma, United States

HD Research LLC | First Surgical Hospital; 🇺🇸 Bellaire, Texas, United States

HD Research LLC | Legent Orthopedic Hospital; 🇺🇸 Carrollton, Texas, United States

Anaheim Clinical Trials; 🇺🇸 Anaheim, California, United States

Trovare Clinical Research | Bakersfield, CA; 🇺🇸 Bakersfield, California, United States

Atlanta Center for Medical Research | Atlanta, GA; 🇺🇸 Atlanta, Georgia, United States

Renovatio Clinical; 🇺🇸 Houston, Texas, United States

Wasatch Clinical Research; 🇺🇸 Salt Lake City, Utah, United States

OrthoNebraska Hospital; 🇺🇸 Omaha, Nebraska, United States

Futuro Clinical Trials; 🇺🇸 McAllen, Texas, United States

South Texas Spine & Surgical Hospital; 🇺🇸 San Antonio, Texas, United States