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

Pain Clinical Trial

Official title:

A Phase 3, Single-arm Study Evaluating the Safety and Effectiveness of VX-548 for Acute Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05661734
• Other study ID #: VX22-548-107
• Status: Completed
• Phase: Phase 3
• Start date: January 9, 2023
• Est. completion date: December 12, 2023

Study information

• Verified date: March 2024
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: December 12, 2023
• Est. primary completion date: December 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Key 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.

Related Conditions & MeSH terms

• Acute Pain
• Pain

Intervention

Drug:
• VX-548
Tablets for oral administration.

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials	Anaheim	California
United States	Atlanta Center for Medical Research | Atlanta, GA	Atlanta	Georgia
United States	Trovare Clinical Research | Bakersfield, CA	Bakersfield	California
United States	HD Research LLC | First Surgical Hospital	Bellaire	Texas
United States	HD Research LLC | Legent Orthopedic Hospital	Carrollton	Texas
United States	Renovatio Clinical	Houston	Texas
United States	Center for Orthopaedic Reconstruction and Excellence	Jenks	Oklahoma
United States	Futuro Clinical Trials	McAllen	Texas
United States	Mart Medical Research Group LLC	Miami	Florida
United States	OrthoNebraska Hospital	Omaha	Nebraska
United States	Wasatch Clinical Research	Salt Lake City	Utah
United States	South Texas Spine & Surgical Hospital	San Antonio	Texas
United States	Mart Medical Research Group LLC	South Miami	Florida
United States	Cypress Surgery Center	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of Participants Reporting Good, Very Good, or Excellent on a Patient Global Assessment (PGA)		Day 2 up to Day 14