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Recruiting
NCT05661734
A Single-arm Study to Evaluate Safety and Effectiveness of VX-548 for Acute Pain
Conditions: Pain
Sex: All
Ages: 18 Years – 80 Years
Phase: PHASE3
Enrollment: 250
Sponsor: Vertex Pharmaceuticals Incorporated
Location: United States
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 NPRSKey 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 allowedHistory 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 studyHistory 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 participantOther protocol defined Inclusion/Exclusion criteria may apply.
Source: ClinicalTrials.gov (NCT05661734). StuddyBuddy aggregates publicly available trial information.