Zilretta for Hip Osteoarthritis

Overseen By Sarah L. Shaffer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Pacira Pharmaceuticals, Inc

Must not be taking: Coumadin, Corticosteroids, Muscle relaxants, others

Disqualifiers: Pregnancy, Inflammatory joint disease, Diabetes, others

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

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an injectable treatment for individuals with hip osteoarthritis, a condition that causes joint pain and stiffness. The trial aims to determine if using two different needle sizes affects the success of injecting the drug Zilretta (a form of triamcinolone acetonide) or its comparison treatment into the hip. Participants who have experienced hip pain from osteoarthritis for at least six months and have significant discomfort may be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it does mention that certain medications like opioids, other analgesics, and THC- or CBD-containing products may need to be stopped. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that Zilretta, a type of triamcinolone acetonide, is generally well-tolerated when injected into the hip. Research indicates that Zilretta's safety profile is similar to other triamcinolone treatments, typically not causing unexpected side effects.

Common side effects of Zilretta may include joint pain or swelling at the injection site. Notably, the FDA has already approved Zilretta for treating knee osteoarthritis, suggesting a good safety record for similar conditions.

As with any medical treatment, some individuals might have allergies, so discussing any known allergies with a healthcare provider before joining a clinical trial is crucial. Consulting with a doctor can help determine if participating in a trial is the right choice. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard of care for hip osteoarthritis, which often involves oral pain relievers or traditional corticosteroid injections, Zilretta offers a unique delivery method. Researchers are excited about Zilretta because it uses triamcinolone acetonide in a sustained-release formulation, providing extended pain relief directly at the site of inflammation. This means Zilretta could potentially offer longer-lasting relief with fewer doses compared to conventional treatments. Additionally, the trial explores different needle sizes, which may optimize the delivery and patient comfort.

What evidence suggests that this trial's treatments could be effective for hip osteoarthritis?

This trial will compare Zilretta, a long-lasting form of triamcinolone acetonide, with a standard triamcinolone acetonide formulation for managing hip osteoarthritis pain. Studies have shown that Zilretta injections in the hip are well-tolerated, with safety comparable to other treatments. Recipients of the injection reported improved physical function and reduced pain for up to 12 weeks. Zilretta has already proven effective for knee osteoarthritis, suggesting potential benefits for hip osteoarthritis as well. This treatment aims to provide long-lasting relief, offering a promising option for those with hip pain due to osteoarthritis. ^{2 4 6 7 8}

Who Is on the Research Team?

Nino Joy

Principal Investigator

Pacira Pharmaceuticals, Inc

Martin Ferrillo

Principal Investigator

Medical Pain Management Services, PLLC

Are You a Good Fit for This Trial?

This trial is for individuals with hip osteoarthritis who are suitable candidates for intra-articular injection treatments. Specific eligibility criteria details were not provided, so it's important to contact the study organizers for more information on who can participate.

Inclusion Criteria

I have had hip pain or symptoms for at least 6 months.

Subjects must have a body mass index (BMI) ≤40 kg/m2 at Screening

Subjects must provide written informed consent prior to initiating any study specific procedures

Exclusion Criteria

I have used corticosteroids in the last 3 months.

Subjects with active substance use disorder or history of substance use disorder within 12 months prior to Screening

I have had treatments on my hip within the required timeframe.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intra-articular injections of ZILRETTA or TCA-IR using different needle sizes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of adverse events and changes in pain and disability scores

12 weeks

Visits at Weeks 1, 4, 8, and 12

What Are the Treatments Tested in This Trial?

Interventions

• Triamcinolone Acetonide
• Zilretta

Trial Overview The study is testing ZILRETTA (an extended-release corticosteroid) against a standard immediate-release Triamcinolone Acetonide injection in patients with hip osteoarthritis. It aims to compare the effectiveness of different needle sizes during the injection procedure.

How Is the Trial Designed?

Group I: 1B ZILRETTA and 22G Needle Experimental Treatment 1 Intervention

32mg ZILRETTA and 22-G Spinal Needle

Group II: 1A: ZILRETTA and 20G Needle Experimental Treatment 1 Intervention

32mg ZILRETTA and 20-G Spinal Needle

Group III: 2A TCA-IR and 20G Needle Active Control 1 Intervention

40mg TCA-IR and 20G Spinal Needle

Group IV: 2B TCA-IR and 22G Needle Active Control 1 Intervention

40mg TCA-IR and 22G Needle

Who Is Running the Clinical Trial?

Pacira Pharmaceuticals, Inc

Lead Sponsor

Trials

142

Recruited

14,300+

Headquarters

Tampa, USA

Known For

Non-opioid Pain Management

Top Products

Exparel, Zilretta, iovera

Dr. Jonathan Slonin

Pacira Pharmaceuticals, Inc

Chief Medical Officer since 2020

BSc in Biomedical Engineering and MD from University of Miami, MBA from George Washington University

Frank D. Lee

Pacira Pharmaceuticals, Inc

Chief Executive Officer since 2024

BSc in Chemical Engineering from Vanderbilt University, MBA from Wharton Graduate School of Business

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8964862/

A Randomized, Open-Label, Single-Dose Study to Assess ... Following a single IA injection in the hip, TA-ER was generally well tolerated, with a safety profile comparable to that of TAcs. Systemic TA ...

2. zilrettapro.com zilrettapro.com/efficacy

ZILRETTA® Efficacy Data | Clinical Trial Results Review ZILRETTA clinical trial design and study outcomes. Access efficacy data and research information for healthcare providers.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06977568

A Study to Evaluate an Intra-Articular Injection of ZILRETTA ... The goal of this clinical trial is to evaluate an injection procedure for the investigational drug in people with Osteoarthritis of the Hip.

4. molinahealthcare.com molinahealthcare.com/-/media/Molina/PublicWebsite/PDF/Providers/ne/Pharmacy/Zilretta_triamcinolone-acetonide-ER-injection_C16855-A.ashx

Zilretta (triamcinolone acetonide ER injection) C16855-A Indicated as an intra-articular injection for the management of osteoarthritis pain of the knee. Limitation of Use: The efficacy and safety of ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S266591312200036X

The effect of intra-articular extended-release triamcinolone ... These data indicate improvement in chair stand performance through 12 weeks post-injection and sustained improvement in participant-reported physical function ...

6. zilretta.com zilretta.com/important-risk-information

ZILRETTA® Safety Information | Risks & Side Effects You should not receive a ZILRETTA injection if you are allergic to corticosteroids, triamcinolone acetonide, or any other component of the product. What ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2017/208845s000lbl.pdf

4163229 This label may not be the latest approved by FDA ... No overall differences in safety or effectiveness were observed between elderly and younger subjects, and other reported clinical experience with triamcinolone ...

8. oarsijournal.com oarsijournal.com/article/S1063-4584(19)30611-9/fulltext

Safety and systemic exposure of triamcinolone acetonide ... Conclusions: In patients with hip OA, a single 32 mg IA injection of TA-ER was generally safe and well tolerated, adding to the established body of evidence in ...