A Single-arm Study to Evaluate Safety and Effectiveness of VX-548 for Acute Pain
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|
Arms and Interventions
Participants will receive VX-548 every 12 hours (q12h) up to 14 days.
Tablets for oral administration.
Primary Outcome Measures
- 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
- Proportion of Participants Reporting Good, Very Good, or Excellent on a Patient Global Assessment (PGA) [Day 2 up to Day 14]
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:
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
|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
Study Documents (Full-Text)None provided.