Osteoarthritis of HipPhase 2NCT06977568
A Study to Evaluate an Intra-Articular Injection of ZILRETTA Versus Triamcinolone Acetonide, Immediate Release in Subjects With Osteoarthritis of the Hip
A Phase 2 study testing Zilretta and Triamcinolone Acetonide in people with Osteoarthritis of Hip, run by Pacira Pharmaceuticals, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Osteoarthritis of Hip
- What is being tested?
- Zilretta and Triamcinolone Acetonide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2025to 16 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 51Show fewer
- 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.
- 5.4. 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.
- Participants who have had prior surgery of the index hip either open or arthroscopic within 6 months of Screening.
- Participants with any retained hardware or foreign body in the index hip.
- Participants with an index hip with major dysplasia or congenital abnormality, osteochondritis dissecans, acromegaly, ochronosis, hemochromatosis, Wilson's disease, primary osteochondromatosis, chondrolysis from a pain pump, or a history of avascular necrosis with secondary OA.
- Participants with a diagnosis of other disorders in the index hip that can cause pain or any concurrent chronic joint, muscle, or nerve pain condition within 1 month prior to Screening (participant self-report acceptable), including but not limited to, back spine pain or conditions causing femoral nerve, obturator nerve, and sciatic nerve injury/entrapment; trochanteric bursitis; diabetic neuropathy of lower extremities; post-herpetic neuralgia; post-stroke pain; or fibromyalgia that may affect sensation of the index hip.
- Participants who have used corticosteroid injections in the index hip (IA, intrabursal, or intratendinous) or intravenous (IV), intramuscular (IM), or oral within 3 months of Screening. Also, participants who will require any systemic steroid use (oral, IV, or IM) while they are in the study are ineligible. Steroid injections in any other joint outside the index hip joint during the study are permitted.
- Participants who have received IA treatment in the index hip with any of the following agents within the 6 months or 5 half-lives prior to Screening: any biologic agent (eg, platelet-rich plasma, stem cells, prolotherapy, amniotic fluid) or hyaluronic acid (within 3 months prior to Screening) (investigational or marketed).
- Participants with a history of or evidence of active or latent systemic fungal or mycobacterial infection (including tuberculosis), or of ocular herpes simplex.
- Participants who have received a live vaccine (eg, measles, mumps, and rubella [MMR], varicella, influenza [nasal spray version only], Bacillus Calmette-Guérin [BCG], and polio) within 3 months prior to Screening.
- Participants who have received an inactivated vaccination (eg, flu, COVID, tetanus, tetanus/diphtheria/pertussis [Tdap], hepatitis A) within 1 week prior to Screening and local injection pain has not resolved.
- Participants with diabetes mellitus with hemoglobin A1c (HbA1c) >8.5% at Screening.
- Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune participants (ie, HBsAg-negative and hepatitis B antibody-positive) may, however, be included.
- Note: Participants who are negative for HBsAg, but positive for HBcAb, would be considered eligible if the absence of HBV DNA is confirmed by HBV DNA polymerase chain reaction reflex testing.
- Participants with chronic hepatitis C virus (HCV) (ie, positive HCV antibody [HCVAb] and HCV RNA).
- Note: Participants who are HCVAb-positive without evidence of HCV RNA may be considered eligible (spontaneous viral clearance or previously treated and cured [defined as no evidence of HCV RNA at least 3 months prior to Day 1/Baseline]).
- Participants with laboratory evidence of infection with human immunodeficiency virus (HIV).
- Participants who have any infection requiring parenteral antibiotics within 4 weeks of Day 1/Baseline or oral antibiotics within 2 weeks of Day 1/Baseline.
- Participants with active substance use disorder (drugs or alcohol) or history of substance use disorder within 12 months prior to Screening. Positive amphetamine results due to prescribed attention deficit/hyperactivity disorder (ADHD) medications with at least 6 months of stable dosing is permitted.
- Participants who use muscle relaxants (eg, cyclobenzaprine, tetrazepam, and diazepam) or oral/topical therapies (eg, nonsteroidal anti-inflammatory drugs [NSAIDs], cannabidiol [CBD] oil, capsaicin, lidocaine patches, or other local treatments) applied to the index hip within 1 month prior to Screening or within 5 half-lives of last dose.
- Participants who use selective serotonin reuptake inhibitors (SSRIs)/serotonin and norepinephrine reuptake inhibitors (SNRIs) (eg, fluoxetine, fluvoxamine, citalopram, escitalopram, sertraline, duloxetine, venlafaxine, and milnacipran) if the dose is not stable for at least 3 months prior to Screening. Participant must remain on a stable dose throughout the study.
- Participants using immunomodulators, immunosuppressives, or chemotherapeutic agents or have used any within 5 years of Screening.
- Participants using any other investigational drug, biologic, or device or have used any within 3 months of Screening.
- Participants who cannot washout prohibited medications (eg, opioids, other analgesics, and tetrahydrocannabinol [THC]- and CBD-containing products) or restricted medications.
- Participants who have any abnormal laboratory value(s) at Screening that, in the opinion of the Investigator (or other authorized clinical staff), precludes study participation.
- Participants with any other clinically significant acute or chronic pain condition that, in the judgment of the Investigator and in consultation with the MM and/or sponsor, would or could compromise (or convey increased risk of) participant safety, limit the participant's ability to complete the study, and/or compromise the objectives of the study.
- Participants with any other clinically significant acute or chronic medical conditions (eg, autoimmune disorder; asthma/chronic obstructive pulmonary disease [COPD], or allergies requiring steroid use; bleeding disorder; other major hematological conditions, cardiac, renal, metabolic, gastrointestinal, neurologic, or psychiatric disease) that, in the judgment of the Investigator and/or in consultation with the MM, would preclude the use of the study drug or IA corticosteroids or that could compromise (or convey increased risk of) participant safety, limit the participant's ability to complete the study, and/or compromise the objectives of the study.
- Participants are the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff, or relative thereof directly involved in the conduct of the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical Pain Management Services PLLC
Albany, New York, 12205
About this study
Official title: A Phase 2, Randomized, Open-Label, Two-Arm Study to Evaluate a Procedure for Intra-Articular Injection of ZILRETTA Versus Triamcinolone Acetonide, Immediate Release (TCA-IR) in Subjects With Osteoarthritis of the Hip
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
- Being tested
- Zilretta, Triamcinolone Acetonide
- Keywords
- ZILRETTA, Osteoarthritis of Hip
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZilrettaDrug
Also called triamcinolone acetonide, extended release injectable suspension
triamcinolone acetonide, extended release injectable suspension
Triamcinolone AcetonideDrug
Also called Triamcinolone Acetonide, Immediate Release, TCA-IR
Triamcinolone Acetonide, Immediate Release (TCA-IR)
| Study group | Role | What they receive |
|---|---|---|
| 1A: ZILRETTA and 20G Needle | Experimental | 32mg ZILRETTA and 20-G Spinal Needle Receives: Drug: Zilretta |
| 1B ZILRETTA and 22G Needle | Experimental | 32mg ZILRETTA and 22-G Spinal Needle Receives: Drug: Zilretta |
| 2A TCA-IR and 20G Needle | Active comparator | 40mg TCA-IR and 20G Spinal Needle Receives: Drug: Triamcinolone Acetonide |
| 2B TCA-IR and 22G Needle | Active comparator | 40mg TCA-IR and 22G Needle Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (3)
TEAE, AESIs, SAEs
Incidence of related treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) from Day 1 through Week 12 for ZILRETTA and TCA-IR.
Measured: From Day 1 through Week 12
Change in 24-hour average pain score
Change from Baseline at Weeks 1, 4, 8, and 12 in the 24-hour average pain score (based on a numerical rating scale [NRS]) for ZILRETTA and TCA-IR . Average pain score is rated on a numerical scale between 0 (no pain) and 10 (worst possible pain).
Measured: Change from Baseline to Week 1, Week 4, Week 8, and Week 12
Change in HOOS Survey
Change from Baseline at Weeks 1, 4, 8, and 12 on the Hip Disability and Osteoarthritis Outcome Score (HOOS) total score and all subscales for ZILRETTA and TCA-IR. The HOOS includes 40 questions with five possible responses, graded from 0 to 4. Total HOOS to be calculated.
Measured: Change from Baseline to Week 1, Week 4, Week 8, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start25 Jul 2025
- Primary completion16 Oct 2025
- Study completion16 Oct 2025
Why it stopped: Study was stopped due to business decision and lack of enrollment. There were no safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nino Joy, Study director, Pacira Pharmaceuticals, IncMartin Ferrillo, Principal investigator, Medical Pain Management Services, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977568
- Sponsor's protocol ID
- 006-C-202
- Status last verified
- Dec 2025
- First submitted
- 7 May 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Based on written request for IPD sharing.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Open-Label, Two-Arm Study to Evaluate a Procedure for Intra-Articular Injection of ZILRETTA Versus Triamcinolone Acetonide, Immediate Release (TCA-IR) in Subjects With Osteoarthritis of the Hip
- ClinicalTrials.gov ID
- NCT06977568
- Acronym / sponsor ID
- 006-C-202
- Conditions
- Osteoarthritis of Hip
- Keywords
- ZILRETTA, Osteoarthritis of Hip
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped due to business decision and lack of enrollment. There were no safety concerns.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 16 Oct 2025 (actual)
- Study completion
- 16 Oct 2025 (actual)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| 1A: ZILRETTA and 20G Needle | Experimental | Drug: Zilretta32mg ZILRETTA and 20-G Spinal Needle |
| 1B ZILRETTA and 22G Needle | Experimental | Drug: Zilretta32mg ZILRETTA and 22-G Spinal Needle |
| 2A TCA-IR and 20G Needle | Active comparator | Drug: Triamcinolone Acetonide40mg TCA-IR and 20G Spinal Needle |
| 2B TCA-IR and 22G Needle | Active comparator | Drug: Triamcinolone Acetonide40mg TCA-IR and 22G Needle |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (51 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZilrettaAlso: triamcinolone acetonide, extended release injectable suspensiontriamcinolone acetonide, extended release injectable suspension | Drug | 1A: ZILRETTA and 20G Needle, 1B ZILRETTA and 22G Needle |
| Triamcinolone AcetonideAlso: Triamcinolone Acetonide, Immediate Release, TCA-IRTriamcinolone Acetonide, Immediate Release (TCA-IR) | Drug | 2A TCA-IR and 20G Needle, 2B TCA-IR and 22G Needle |
Primary outcome
Assessment of Successful Hip injection Rate
Time frame: Day 1
The assessment of successful hip injection rate (injection of the full dose) for ZILRETTA and TCA-IR based on the 2 different needle-gauges
3 secondary outcomes
TEAE, AESIs, SAEs
Time frame: From Day 1 through Week 12
Change in 24-hour average pain score
Time frame: Change from Baseline to Week 1, Week 4, Week 8, and Week 12
Change in HOOS Survey
Time frame: Change from Baseline to Week 1, Week 4, Week 8, and Week 12
Results and safety
The study was stopped early (reason given: Study was stopped due to business decision and lack of enrollment. There were no safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: Yes. Based on written request for IPD sharing.
Related trials for Osteoarthritis of Hip
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nino Joy study director
Pacira Pharmaceuticals, Inc
Martin Ferrillo principal investigator
Medical Pain Management Services, PLLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zilretta and Triamcinolone Acetonide in people with Osteoarthritis of Hip, run by Pacira Pharmaceuticals, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 51 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study was stopped due to business decision and lack of enrollment. There were no safety concerns.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Successful Hip injection Rate (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.