F14 for Postoperative Pain After Knee Replacement

Recruiting at 6 trial locations

Overseen By Matthew Shive, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Arthritis Innovation Corporation

Must not be taking: NSAIDs, Marijuana, Opioids, others

Disqualifiers: Cardiovascular, Neurological, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

151 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if injecting a long-lasting painkiller called celecoxib into the knee can help reduce pain for patients having knee replacement surgery. The medication works by blocking chemicals that cause pain and swelling. Celecoxib has been shown to be effective in reducing pain and improving function in patients with knee osteoarthritis.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications. You must discontinue nonsteroidal anti-inflammatory drugs (NSAIDs), medical or recreational marijuana, cannabidiol (CBD), pregabalin, gabapentin, and opioid analgesics at least 7 to 10 days before the surgery and for a specified period after the surgery.

Research Team

Matthew Shive, PhD

Principal Investigator

Arthritis Innovation Corporation

Eligibility Criteria

Adults aged 45-80, with a BMI ≤ 40 kg/m2, scheduled for unilateral total knee replacement surgery can join. They must have stable health as confirmed by tests and no recent injections or major surgeries in the affected knee. Women of childbearing age need a negative pregnancy test and agree to birth control measures.

Inclusion Criteria

Capable of giving signed informed consent and complying with requirements and restrictions listed in the informed consent form (ICF) and in this protocol

My knees do not have severe inward or outward bending.

My health is good enough for surgery according to the ASA score.

Exclusion Criteria

You have a history of heavy drinking within the past year.

I was diagnosed with bone tissue death in the last year.

You are currently involved in a legal case related to an injury to your knee.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intra-articular dose of F14 (625 mg sustained release celecoxib) concurrent with multimodal analgesia during total knee replacement surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-6 weeks

Treatment Details

Interventions

• F14

Trial Overview The trial is testing F14 (a sustained release form of celecoxib) combined with standard pain management against standard treatment alone after knee replacement surgery. It's randomized and double-blind, meaning neither patients nor doctors know who gets which treatment.

Participant Groups

Group I: F14 + Multimodal Analgesia Experimental Treatment 4 Interventions

Group II: Multimodal Analgesia Active Control 3 Interventions

Who Is Running the Clinical Trial?

Arthritis Innovation Corporation

Lead Sponsor

Trials

3

Recruited

270+

Allucent

Collaborator

Trials

4

Recruited

350+