A Study to Evaluate an Intra-Articular Injection of ZILRETTA Versus Triamcinolone Acetonide, Immediate Release in Subjects With Osteoarthritis of the Hip

Stopped early · Phase 2

Conditions studied: Osteoarthritis of Hip

In brief

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.

Key facts

Study ID

NCT06977568

Run by

Pacira Pharmaceuticals, Inc

People needed

1

Starts

2025-07-25

Expected to finish

2025-10-16

Last updated by the study team

2025-12-22

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants are eligible to be included in the study only if all of the following criteria apply:
• Participants must provide written informed consent prior to initiating any study specific procedures.
• Participants must be willing and able to comply with the study procedures and visit schedule and to follow verbal and written instructions.
• Participants must be male or female and 50 to 80 years old, inclusive, on the day of consent.
• Participants must have a body mass index (BMI) ≤40 kg/m2 at Screening.
• Participants must exhibit symptoms associated with unilateral or bilateral hip OA for at least 6 months prior to Screening.
• Participants with unilateral or bilateral hip pain must have a 24-hour average pain score (based on a numerical rating scale [NRS]) between ≥5.0 and ≤9.0 for the index hip and <5 in contralateral hip at Screening.
• Participants must have K-L Grade 1, 2, 3, or 4 in the index hip (ie, the hip identified by the Investigator as appropriate for injection) confirmed by X-ray obtained during Screening or within ≤6 months prior to the Screening visit.
• Participants must have an index hip examination indicating the index hip and the intended injection site area must be free of any signs of local or joint infection at Day 1/Baseline. Participants must also not have a history of infection (eg, osteomyelitis) in the index hip or injection site.
• Sexually active participants of child-bearing potential (POCBP; defined as neither surgically sterile nor postmenopausal, ie, age >45 years and no menstrual periods for at least 1 year without an alternative medical cause) must agree to use, from Screening through 14 weeks postinjection for biologically female participants and through 23 weeks postinjection for biologically male participants, a highly effective method of contraception, defined as one of the following: abstinence; oral, injected, or implanted hormonal methods of contraception; intrauterine device or intrauterine contraceptive system; condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; or sexual intercourse only with biological male ≥6 months post-vasectomy.
• 4. Exclusion Criteria
• Participants are excluded from the study if any of the following criteria apply:
• Participants who are pregnant, nursing, lactating, or plan to become, or their partner plans to become, pregnant during the study.
• Participants with a history of hypersensitivity to triamcinolone acetonide, PLGA, or lidocaine.
• Participants with hypersensitivity or allergy to Omnipaque 300 or iodine.
• Participants with a contraindication to the use of acetaminophen/paracetamol (allowed rescue pain medicine) per National Product Labeling and Investigator's judgment.
• Participants currently taking coumadin or have taken coumadin for ≥3 weeks prior to Day 1/Baseline.
• Participants with a history of or active significant concomitant illness (known or suspected) including, but not limited to:
• Inflammatory joint disease, eg, rheumatoid arthritis, seronegative spondyloarthropathy, ankylosing spondylitis, psoriatic arthritis, reactive arthritis, inflammatory-bowel disease-associated inflammatory arthritis.
• Systemic inflammatory disease, eg, polymyalgia rheumatica, systemic lupus erythematosus.
• Sarcoidosis or amyloidosis.
• Cushing's syndrome.
• Malignancy requiring systemic therapy within the past 5 years (excludes basal cell carcinoma or cervical cancer treated only with surgical removal more than 1 year prior).
• Other autoimmune disease.
• Participants who have had any previous substantial hip injury (eg, hip dislocation, partial or complete hip fraction), which resulted in functional limitation or immobilization within 3 months prior to Screening.

Where it is running

• Medical Pain Management Services PLLC — Albany, New York, United States

Full record on ClinicalTrials.gov

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