F14 + Multimodal Analgesia for Postoperative pain

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Postoperative pain+1 More
F14 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Postoperative pain

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 6 weeks

2 weeks
Proportion of subjects using opioid rescue medication at 2 weeks
Pain
3 days
Pain
6 weeks
Knee

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Multimodal Analgesia
1 of 2
F14 + Multimodal Analgesia
1 of 2

Active Control

Experimental Treatment

150 Total Participants · 2 Treatment Groups

Primary Treatment: F14 + Multimodal Analgesia · No Placebo Group · Phase 3

F14 + Multimodal AnalgesiaExperimental Group · 4 Interventions: F14, Acetaminophen, Methocarbamol, 0.25 % Bupivacaine HCl · Intervention Types: Drug, Drug, Drug, Drug
Multimodal AnalgesiaActiveComparator Group · 3 Interventions: Acetaminophen, Methocarbamol, 0.25 % Bupivacaine HCl · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetaminophen
2017
Completed Phase 4
~2080
Methocarbamol
2016
Completed Phase 4
~480

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 weeks

Who is running the clinical trial?

Arthritis Innovation CorporationLead Sponsor
2 Previous Clinical Trials
120 Total Patients Enrolled
AllucentUNKNOWN
1 Previous Clinical Trials
69 Total Patients Enrolled
Matthew Shive, PhDStudy DirectorArthritis Innovation Corporation

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are capable of giving informed consent and complying with requirements and restrictions listed in the ICF and in this protocol.
You have a body mass index (BMI) of 40 kg/m2 or less.
You have a minimum flexion arc of 100o.
Male and/or females indicated for primary, unilateral TKR.
You are between 45 and 80 years of age at the time of signing the informed consent.
You are medically stable as determined by the Investigator.
You have no moderate to severe varus or valgus deformity.
The diagnosis of osteoarthritis of the knee is based on the clinical history and physical examination

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 8th, 2021

Last Reviewed: November 29th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.