F14 for Postoperative Pain After Knee Replacement

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new pain treatment, F14, for individuals who have undergone knee replacement surgery. F14 is a special form of the pain medication celecoxib, designed for slow release, and is being tested alongside other pain management methods. The study compares this combination to standard pain management alone to determine if F14 provides better relief. Individuals undergoing a single knee replacement who have not received certain knee treatments in the last three months may qualify for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the development of a potentially groundbreaking pain management option.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that F14, a pain reliever similar to celecoxib, is being tested to manage pain after knee replacement surgery. In earlier studies, researchers administered a single dose of F14 directly into the knee. They closely monitored the safety of F14 by checking for side effects, assessing heart function with ECGs, and evaluating overall health through blood tests and physical exams.

These studies found that F14 is generally well-tolerated, with most participants experiencing no major side effects. The treatment is in a late stage of testing, indicating strong evidence of its safety. Celecoxib, the main ingredient in F14, has already received FDA approval for other uses, suggesting it is considered safe for those conditions.

Prospective trial participants may find this information helpful in understanding the treatment's safety record so far. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for postoperative pain?

Researchers are excited about F14 for postoperative pain after knee replacement because it offers potential advantages over traditional pain management methods like opioids and non-steroidal anti-inflammatory drugs (NSAIDs). Unlike other treatments that primarily focus on pain relief through general analgesic effects, F14 is designed to work synergistically with existing multimodal analgesia techniques, potentially enhancing pain control and reducing reliance on opioids. This could lead to fewer side effects and a lower risk of opioid dependency, making F14 a promising option for managing postoperative pain more effectively and safely.

What evidence suggests that F14 might be an effective treatment for postoperative pain after knee replacement?

Research has shown that F14, which uses a slow-release form of celecoxib, may help manage pain after knee replacement surgery. In earlier studies, patients who received F14 reported less pain than those who did not. Celecoxib, a long-lasting pain reliever, reduces swelling and pain when injected directly into the knee. In this trial, participants will receive either F14 combined with Multimodal Analgesia or Multimodal Analgesia alone. These early results offer promise for those considering joining a trial to learn more about this treatment. ^{1 4 6 7 8}

Who Is on the Research Team?

Matthew Shive, PhD

Principal Investigator

Arthritis Innovation Corporation

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03541655?spons=COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Arthritis%20Innovation%20Corporation%22)&viewType=Table&rank=3

Safety and Activity of F14 for Management of Pain ... This is a randomized, single-blind, active control study in participants undergoing primary unilateral total knee replacement (TKR).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05603832

NCT05603832 | A Phase 3 Study of F14 for Management ... 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.

3. trial.medpath.com trial.medpath.com/clinical-trial/8d5f18f7367d6b1d/nct03541655-phase-2-study-f14-postoperative-pain

Safety and Activity of F14 for Management of Pain Following ... This is a randomized, single-blind, active control study in participants undergoing primary unilateral total knee replacement (TKR).

4. withpower.com withpower.com/trial/phase-3-pain-postoperative-10-2022-ef9bc

F14 for Postoperative Pain After Knee Replacement This trial tests if injecting a long-lasting painkiller called celecoxib into the knee can help reduce pain for patients having knee replacement surgery.

5. ctv.veeva.com ctv.veeva.com/study/safety-and-activity-of-f14-for-management-of-pain-following-total-knee-replacement

Safety and Activity of F14 for Management of Pain Following ... This is a randomized, single-blind, active control study in participants undergoing primary unilateral total knee replacement (TKR). Fifty (50) ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03541655

Study Details | NCT03541655 | Safety and Activity of F14 ... Post-operative pain will be assessed using visual analog scores (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaires ...

7. ctv.veeva.com ctv.veeva.com/study/a-phase-3-study-of-f14-for-management-of-pain-following-total-knee-replacement

A Phase 3 Study of F14 for Management of Pain Following ... 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.

8. clinicaltrialsarena.com clinicaltrialsarena.com/news/aic-patient-enrolment-f14-trial/

AIC concludes patient enrolment in F14 trial The double-blind, multicentre, randomised study intends to assess the safety and efficacy of a single dose of F14 for post-operative analgesia ...