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

Vertex Pharmaceuticals Incorporated (Industry)
Overall Status
CT.gov ID

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Anticipated Enrollment :
250 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
A Phase 3, Single-arm Study Evaluating the Safety and Effectiveness of VX-548 for Acute Pain
Actual Study Start Date :
Jan 9, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: VX-548

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

Drug: VX-548
Tablets for oral administration.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Proportion of Participants Reporting Good, Very Good, or Excellent on a Patient Global Assessment (PGA) [Day 2 up to Day 14]

Eligibility Criteria


Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
Accepts 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.

Contacts and Locations


Site City State Country Postal Code
1 Trovare Clinical Research | Bakersfield, CA Bakersfield California United States 93301
2 Mart Medical Research Group LLC South Miami Florida United States 33143
3 Futuro Clinical Trials McAllen Texas United States 78501
4 Renovatio Clinical Woodland Texas United States 77380

Sponsors and Collaborators

  • Vertex Pharmaceuticals Incorporated


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • VX22-548-107
First Posted:
Dec 22, 2022
Last Update Posted:
Jan 25, 2023
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 25, 2023