Clinical trial NCT05661734: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2022-12-22
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 up to Day 28
Secondary outcomes:
measure: Proportion of Participants Reporting Good, Very Good, or Excellent on a Patient Global Assessment (PGA)
timeFrame: Day 2 up to Day 14
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Bakersfield
country: United States
facility: Trovare Clinical Research | Bakersfield, CA
state: California
city: Miami
country: United States
facility: Mart Medical Research Group LLC
state: Florida
city: South Miami
country: United States
facility: Mart Medical Research Group LLC
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research | Atlanta, GA
state: Georgia
city: Wichita
country: United States
facility: Cypress Surgery Center
state: Kansas
city: Omaha
country: United States
facility: OrthoNebraska Hospital
state: Nebraska
city: Jenks
country: United States
facility: Center for Orthopaedic Reconstruction and Excellence
state: Oklahoma
city: Bellaire
country: United States
facility: HD Research LLC | First Surgical Hospital
state: Texas
city: Carrollton
country: United States
facility: HD Research LLC | Legent Orthopedic Hospital
state: Texas
city: Houston
country: United States
facility: Renovatio Clinical
state: Texas
city: McAllen
country: United States
facility: Futuro Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: South Texas Spine & Surgical Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
Study officials:
References: