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

Primary Purpose

Pain

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
VX-548
Sponsored by
Vertex Pharmaceuticals Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Center - Tucson Orthopeadic Institute
  • Anaheim Clinical TrialsRecruiting
  • Trovare Clinical Research | Bakersfield, CARecruiting
  • New Hope Research Development | Tarzana, CARecruiting
  • Mart Medical Research Group LLC
  • Atlanta Center for Medical Research | Atlanta, GARecruiting
  • Duly HealthRecruiting
  • Cypress Surgery CenterRecruiting
  • OrthoNebraska HospitalRecruiting
  • Center for Orthopaedic Reconstruction and ExcellenceRecruiting
  • HD Research LLC | First Surgical HospitalRecruiting
  • HD Research LLC | Legent Orthopedic HospitalRecruiting
  • Futuro Clinical TrialsRecruiting
  • South Texas Spine & Surgical HospitalRecruiting
  • Renovatio Clinical
  • Wasatch Clinical Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VX-548

Arm Description

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

Outcomes

Primary Outcome Measures

Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Secondary Outcome Measures

Proportion of Participants Reporting Good, Very Good, or Excellent on a Patient Global Assessment (PGA)

Full Information

First Posted
December 14, 2022
Last Updated
October 13, 2023
Sponsor
Vertex Pharmaceuticals Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT05661734
Brief Title
A Single-arm Study to Evaluate Safety and Effectiveness of VX-548 for Acute Pain
Official Title
A Phase 3, Single-arm Study Evaluating the Safety and Effectiveness of VX-548 for Acute Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vertex Pharmaceuticals Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VX-548
Arm Type
Experimental
Arm Description
Participants will receive VX-548 every 12 hours (q12h) up to 14 days.
Intervention Type
Drug
Intervention Name(s)
VX-548
Intervention Description
Tablets for oral administration.
Primary Outcome Measure Information:
Title
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
Day 1 up to Day 28
Secondary Outcome Measure Information:
Title
Proportion of Participants Reporting Good, Very Good, or Excellent on a Patient Global Assessment (PGA)
Time Frame
Day 2 up to Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Medical Information
Phone
617-341-6777
Email
medicalinfo@vrtx.com
Facility Information:
Facility Name
Research Center - Tucson Orthopeadic Institute
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Individual Site Status
Completed
Facility Name
Anaheim Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Individual Site Status
Recruiting
Facility Name
Trovare Clinical Research | Bakersfield, CA
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Individual Site Status
Recruiting
Facility Name
New Hope Research Development | Tarzana, CA
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Individual Site Status
Recruiting
Facility Name
Mart Medical Research Group LLC
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Individual Site Status
Completed
Facility Name
Atlanta Center for Medical Research | Atlanta, GA
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Individual Site Status
Recruiting
Facility Name
Duly Health
City
Westmont
State/Province
Illinois
ZIP/Postal Code
60559
Country
United States
Individual Site Status
Recruiting
Facility Name
Cypress Surgery Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Individual Site Status
Recruiting
Facility Name
OrthoNebraska Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Individual Site Status
Recruiting
Facility Name
Center for Orthopaedic Reconstruction and Excellence
City
Jenks
State/Province
Oklahoma
ZIP/Postal Code
74037
Country
United States
Individual Site Status
Recruiting
Facility Name
HD Research LLC | First Surgical Hospital
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Name
HD Research LLC | Legent Orthopedic Hospital
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75006
Country
United States
Individual Site Status
Recruiting
Facility Name
Futuro Clinical Trials
City
McAllen
State/Province
Texas
ZIP/Postal Code
78501
Country
United States
Individual Site Status
Recruiting
Facility Name
South Texas Spine & Surgical Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Individual Site Status
Recruiting
Facility Name
Renovatio Clinical
City
Woodland
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Individual Site Status
Completed
Facility Name
Wasatch Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

Learn more about this trial

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

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