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Corticosteroid

FX006 Injection for Rotator Cuff Disease

Phase 3

Recruiting

Led By Russell Camhi

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Musculoskeletal Ultrasound indicating intact RTC, full thickness tears, or large and massive cuff tears in older, sedentary individuals.

Male or female between the ages of 40-75 years old.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Study Summary

This trial is testing a new medication, extended release triamcinolone acetate, to see if it is safe and tolerable for patients with shoulder pain from rotator cuff disease. The study will enroll 65 patients, aged 40-75 years old, in a longitudinal case series level IV study.

Who is the study for?

This trial is for adults aged 40-75 with shoulder pain from rotator cuff disease, confirmed by physical exam and X-rays or ultrasound. Participants must read and speak English, consent to the study's terms, and agree not to use NSAIDs or conceive during the trial. Pregnant/nursing individuals or those with hypersensitivity to FX006/triamcinolone acetonide are excluded.Check my eligibility

What is being tested?

The trial is testing an extended release triamcinolone acetate injection (FX006) for safety and tolerability in treating shoulder pain associated with rotator cuff disease. It involves a longitudinal case series level IV study design enrolling 65 patients.See study design

What are the potential side effects?

While specific side effects of FX006 aren't listed here, common side effects of corticosteroid injections like triamcinolone can include pain at the injection site, infection risk increase, tendon weakening or rupture, skin discoloration, allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My ultrasound shows my shoulder's rotator cuff is either intact, has full tears, or large tears especially since I'm older and not very active.

Select...

I am between 40 and 75 years old.

Select...

I have a history of shoulder problems related to the rotator cuff.

Select...

My physical exam shows signs of rotator cuff disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events

Secondary outcome measures

Body Weight Changes

Change in shoulder function as assessed by SANE

Body Weight Changes

+1 more

Side effects data

From 2018 Phase 3 trial • 208 Patients • NCT03046446

29%

Arthralgia

Upper respiratory tract infection

Back pain

Joint swelling

Muscle spasms

Joint crepitation

Joint effusion

Influenza

Nasopharyngitis

Ligament sprain

100%

80%

60%

40%

20%

Study treatment Arm

FX006 32 mg

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment GroupExperimental Treatment1 Intervention

Patients receiving the 32-unit injection of FX006.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor

460 Previous Clinical Trials

470,978 Total Patients Enrolled

Russell Camhi4.619 ReviewsPrincipal Investigator - Northwell Health

Medical School - Midwestern University, Arizona College of Osteopathic Medicine, Doctor of Osteopathic Medicine

Plainview Hospital, Residency in Family Medicine

5Patient Review

Competent and professional.

Media Library

FX006 Injection (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04094298 — Phase 3

Rotator Cuff Tears Research Study Groups: Treatment Group

Rotator Cuff Tears Clinical Trial 2023: FX006 Injection Highlights & Side Effects. Trial Name: NCT04094298 — Phase 3

FX006 Injection (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04094298 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has a similar test been conducted before?

"To date, 5 trials for FX006 Injection are ongoing in 46 cities and 18 countries. The initial study was completed in 2016 by Pfizer. That Phase 3 approval trial included 1637 patients. In the years since 2016, an additional 31 studies have been undertaken."

Answered by AI

How many study participants are you enrolling for this research?

"That is accurate. The listing for this clinical trial on clinicaltrials.gov shows that the research is currently underway and actively recruiting patients. The study was first posted on 7/15/2019, and the most recent update was on 11/16/2021. They are hoping to enroll 65 patients from 1 site."

Answered by AI

Is there room for new participants in this experiment?

"That is correct. The clinicaltrials.gov website shows that this study, which was originally published on 7/15/2019, is still recruiting patients. They are looking for a total of 65 individuals from 1 site."

Answered by AI

What is the process for getting FDA approval for FX006 Injection?

"There is both pre-existing data to support the efficacy of FX006 Injection as well as multiple rounds of safety trials, so it received a score of 3."

Answered by AI

Has FX006 Injection been trialed before in other medical studies?

"Currently, there are 5 separate trials underway studying FX006 Injection. Out of those 5, 2 are in Phase 3. Although the majority of research is taking place in Beijing, Beijing, there are a total of 107 locations conducting these investigations."

Answered by AI