drugset / Trial / NCT04977336
A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating acute pain after a bunionectomy.
Timeline
- Start
- 2021-07-19
- Primary completion
- 2022-02-17
- Completion
- 2022-03-04
Publications
- Jones J, Correll DJ, Lechner SM, Jazic I, Miao X, Shaw D, Simard C, Osteen JD, Hare B, Beaton A, Bertoch T, Buvanendran A, Habib AS, Pizzi LJ, Pollak RA, Weiner SG, Bozic C, Negulescu P, White PF; VX21-548-101 and VX21-548-102 Trial Groups. Selective Inhibition of NaV1.8 with VX-548 for Acute Pain. N Engl J Med. 2023 Aug 3;389(5):393-405. doi: 10.1056/NEJMoa2209870.
- Russo MA, Baron R, Dickenson AH, Kern KU, Santarelli DM. Ambroxol for neuropathic pain: hiding in plain sight? Pain. 2023 Jan 1;164(1):3-13. doi: 10.1097/j.pain.0000000000002693. Epub 2022 May 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Acetaminophen | Small molecule | 325 mg | Oral |
| Subject | Suzetrigine | Small molecule | 10 mg | Oral |
| Subject | Suzetrigine | Small molecule | 30 mg | Oral |
| Subject | Suzetrigine | Small molecule | 50 mg | Oral |
| Comparator | hydrocodone bitartrate | Unknown | 5 mg | Oral |
Indications
No indication recorded.