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

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate an injection procedure for the investigational drug in people with Osteoarthritis of the Hip. The Sponsor is conducting this research to evaluate successful injections in the hip by using two different needle sizes.

Research Team

Nino Joy

Principal Investigator

Pacira Pharmaceuticals, Inc

Martin Ferrillo

Principal Investigator

Medical Pain Management Services, PLLC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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