NCT03541655

Safety and Activity of F14 for Management of Pain Following Total Knee Replacement

A Phase 2, Randomized, Single-Blind, Active-Control, Parallel Group Study to Evaluate Safety and Activity of a Single Administration of F14 for Management of Postoperative Pain in Participants Undergoing Unilateral Total Knee Replacement

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Arthritis Innovation Corporation · Industry
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The safety and activity of a single, 3.5 mL dose of F14 (celecoxib) concurrent with standard of care analgesia administered following total knee replacement will be compared to standard of care analgesia alone.

Detailed description

This is a randomized, single-blind, active control study in participants undergoing primary unilateral total knee replacement (TKR). Fifty (50) participants will be randomized 1:1 to receive either a single, 3.5 mL dose of F14 (celecoxib) concurrent with standard of care analgesia, or only standard of care analgesia. F14 will be administered into the joint space at the end of surgery and just prior to wound closing. Safety will be evaluated through recording of adverse events, vital signs, ECG, physical and knee-specific examinations, laboratory blood tests and standing x-rays of the TKR obtained at 3 and 12 months. Post-operative pain will be assessed using visual analog scores (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaires and the Timed Up and Go test. Concomitant medication usage including MSO4 equivalents will be monitored daily for 3 months with participant drug diaries, and at the 12-month visit. Perceived benefit of analgesia will be compared using the Overall Benefit of Analgesic Score (OBAS). The pharmacokinetic profile of celecoxib in plasma will be assessed up to 3 months. Standardized physical therapy will be implemented post-operatively. Follow-up study visits will occur at 1, 2, 3, 4 (phone) and 6 weeks, 3 and 12 months.

Conditions

• Total Knee Replacement
• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Bupivacaine HCl	0.25% Bupivacaine HCl
DRUG	F14 (celecoxib)	Celecoxib in novel drug delivery system (BEPO™)

Timeline

• Start date: 2018-05-04
• Primary completion: 2019-06-20
• Completion: 2020-03-30
• First posted: 2018-05-30
• Last updated: 2020-07-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study