drugset / Trial / NCT05603832

A Phase 3 Study of F14 for Management of Pain Following Total Knee Replacement

NCT05603832

Phase 3 Completed 151 enrolled Arthritis Innovation Corporation Allucent · collab
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

EvaluationDrugModalityDoseRoute
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.