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

NCT05603832 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2025-12-18

No results posted yet for this study

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

DRUG

F14

625 mg intra-articular sustained-release celecoxib

DRUG

0.25 % Bupivacaine HCl

Local anesthetic

DRUG

Acetaminophen

Analgesic

DRUG

Methocarbamol

Muscle relaxant

Sponsors & Collaborators

  • Allucent

    collaborator UNKNOWN

  • Arthritis Innovation Corporation

    lead INDUSTRY

Principal Investigators

  • Matthew Shive, PhD · Arthritis Innovation Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-17
Primary Completion
2023-11-22
Completion
2024-08-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05603832 on ClinicalTrials.gov