NCT05603832

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

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel Group Study of the Efficacy and Safety of a Single Administration of F14 for Postoperative Analgesia in Patients Undergoing Unilateral Total Knee Replacement

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Arthritis Innovation Corporation · Industry
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post Operative Pain

Interventions

Type	Name	Description
DRUG	F14	625 mg intra-articular sustained-release celecoxib
DRUG	0.25 % Bupivacaine HCl	Local anesthetic
DRUG	Acetaminophen	Analgesic
DRUG	Methocarbamol	Muscle relaxant

Timeline

• Start date: 2022-11-17
• Primary completion: 2023-11-22
• Completion: 2024-08-23
• First posted: 2022-11-03
• Last updated: 2025-12-18

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study