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

NCT06977568 | Terminated Phase 2 FDA Drug

• 1 other identifier: 006-C-202
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis of Hip

Keywords

ZILRETTA; Osteoarthritis of Hip

Outcome Measures

Primary Outcomes (1)

• Assessment of Successful Hip injection Rate

  The assessment of successful hip injection rate (injection of the full dose) for ZILRETTA and TCA-IR based on the 2 different needle-gauges

  Day 1

Secondary Outcomes (3)

• TEAE, AESIs, SAEs

  From Day 1 through Week 12

• Change in 24-hour average pain score

  Change from Baseline to Week 1, Week 4, Week 8, and Week 12

• Change in HOOS Survey

  Change from Baseline to Week 1, Week 4, Week 8, and Week 12

Study Arms (4)

1A: ZILRETTA and 20G Needle

EXPERIMENTAL

32mg ZILRETTA and 20-G Spinal Needle

Drug: Zilretta

1B ZILRETTA and 22G Needle

EXPERIMENTAL

32mg ZILRETTA and 22-G Spinal Needle

Drug: Zilretta

2A TCA-IR and 20G Needle

ACTIVE COMPARATOR

40mg TCA-IR and 20G Spinal Needle

Drug: Triamcinolone Acetonide

2B TCA-IR and 22G Needle

ACTIVE COMPARATOR

40mg TCA-IR and 22G Needle

Drug: Triamcinolone Acetonide

Interventions

Zilretta DRUG

triamcinolone acetonide, extended release injectable suspension

Also known as: triamcinolone acetonide, extended release injectable suspension

1A: ZILRETTA and 20G Needle; 1B ZILRETTA and 22G Needle

Triamcinolone Acetonide DRUG

Triamcinolone Acetonide, Immediate Release (TCA-IR)

Also known as: Triamcinolone Acetonide, Immediate Release, TCA-IR

2A TCA-IR and 20G Needle; 2B TCA-IR and 22G Needle

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

You may not qualify if:

• 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.
• Participants who have had prior surgery of the index hip either open or arthroscopic within 6 months of Screening.

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (1)

Medical Pain Management Services PLLC

Albany, New York, 12205, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Triamcinolone; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Nino Joy

  Pacira Pharmaceuticals, Inc

  STUDY DIRECTOR

• Martin Ferrillo

  Medical Pain Management Services, PLLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomly assigned to 1 of the 2 treatment arms: 1:1 across the 2 study drugs (ZILRETTA and TCA-IR) and a 1:1 ratio within each needle-gauge size (20- and 22-G) (approximately 8 subjects assigned to Arm 1A, approximately 8 subjects assigned to Arm 1B, approximately 8 subjects assigned to Arm 2A, and approximately 8 subjects assigned to Arm 2B)

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 18, 2025
• Study Start: July 25, 2025
• Primary Completion: October 16, 2025
• Study Completion: October 16, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Based on written request.
• Access Criteria: Based on written request.

Locations

US (1)