drugset / Trial / NCT05603832
A Phase 3 Study of F14 for Management of Pain Following Total Knee Replacement
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a Phase 3, randomized, double blind, multicenter study to evaluate the analgesic efficacy and safety of a single intra-articular dose of F14 (625 mg sustained release celecoxib) administered concurrent with multimodal analgesia in patients undergoing total knee replacement surgery, compared to multimodal analgesia alone.
Timeline
- Start
- 2022-11-17
- Primary completion
- 2023-11-22
- Completion
- 2024-08-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Celecoxib | Other / unclassified | 625 mg | Other |
| Background | Acetaminophen | Small molecule | — | — |
| Background | Bupivacaine | Other / unclassified | 0.25 % | — |
| Background | Methocarbamol | Small molecule | — | — |
Indications
No indication recorded.