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

• Sponsor: Vertex Pharmaceuticals Incorporated (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05661734
• Collaborator: (none)
• Enrollment: 250
• Locations: 4
• Arm: 1
• Anticipated Duration (Months): 13.7
• Patients Per Site: 62.5
• Patients Per Site Per Month: 4.6

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
Pain	Drug: VX-548	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 250 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vertex Pharmaceuticals Incorporated
• ClinicalTrials.gov Identifier: NCT05661734
• 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: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acute Pain

Study Results

No Results Posted as of Jan 25, 2023