A Study to Evaluate an Intra-Articular Injection of ZILRETTA Versus Triamcinolone Acetonide, Imme… (NCT06977568) | Clinical Trial Compass
TerminatedPhase 2
A Study to Evaluate an Intra-Articular Injection of ZILRETTA Versus Triamcinolone Acetonide, Immediate Release in Subjects With Osteoarthritis of the Hip
Stopped: Study was stopped due to business decision and lack of enrollment. There were no safety concerns.
United States1 participantsStarted 2025-07-25
Plain-language summary
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.
Who can participate
Age range50 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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:
✕. 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.
✕. Participants who have had prior surgery of the index hip either open or arthroscopic within 6 months of Screening.