- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03382262
Study to Compare Exposure of TA Following Administration of FX006 or TAcs in Patients With OA of the Shoulder or Hip
A Randomized, Open-label Study Comparing the Systemic Exposure to Triamcinolone Acetonide Following a Single Intra-articular Dose of Extended-release FX006 or Immediate-release TAcs (Triamcinolone Acetonide Suspension) in Patients With Osteoarthritis of the Shoulder (Glenohumeral Joint) or Hip
Study Overview
Status
Intervention / Treatment
Detailed Description
This is a randomized, open-label, single dose study that will be conducted in male and female patients ≥40 years of age with OA of either the shoulder or the hip.
Approximately 24 patients with OA of the shoulder and approximately 24 patients with OA of the hip will be randomized to one of two treatment groups (1:1) and treated with a single IA injection of either:
- 32 mg FX006 (approximately 12 patients per joint) or
- 40 mg TAcs (approximately 12 patients per joint)
Each patient will be screened to confirm the diagnosis of OA of either the shoulder or hip and eligibility based on the other inclusion/exclusion requirements and will be randomized to treatment on Day 1. Each patient will be evaluated for a total of 12 weeks following the IA injection. Following screening, sampling for pharmacokinetics (PK) and safety will be completed at 10 out-patient visits scheduled on Study Days 1 [calendar day of injection], 2, 3, 5, 8, 15, 22, 29, 57, and 85.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
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El Cajon, California, United States, 92020
- TriWest Research Associates, LLC
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La Mesa, California, United States, 91942
- Biosolutions Clinical Research Center
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San Diego, California, United States, 92103
- Artemis Institute for Clinical Research
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Torrance, California, United States, 90509
- LA Biomed at Harbor-UCLA Medical Center
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New York
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Rochester, New York, United States, 14609
- Rochester Clinical Research
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Pennsylvania
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Duncansville, Pennsylvania, United States, 16635
- Altoona Center For Clinical Research
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Written consent to participate in the study
- Male or female greater than or equal to 40 years of age
- Body mass index (BMI) less than or equal to 40 kg/m2
- Ambulatory and in good general health
- Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions
- Willing to abstain from use of protocol-restricted treatments from Screening through End-of-Study visit
- Symptoms consistent with OA of the index joint for ≥ 6 months prior to Screening (patient reported is acceptable)
- Pain in the index joint for greater than15 days over the last month (as reported by the patient)
- For Shoulder OA patients: Radiologic findings of OA of the index shoulder meeting the Samilson-Prieto (S-P) Classification Grades 2 or 3
- For Hip OA patients: ACR Criteria (clinical and radiological) for OA of the index hip
Exclusion Criteria:
- Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
- History of infection in the index joint
- Clinical findings consistent with active infection or crystal disease in the index joint within 1 month of Screening
- History of fracture in the index limb within 12 months of Screening, or fracture with sequelae at any time
- Planned or anticipated surgery of the index joint during the study period
- Index joint instability or history of acute dislocation within 12 months of Screening
- If shoulder is the index joint, history of full or partial rotator cuff tear or significantly compromised rotator cuff function that, in the opinion for the Investigator, increases the difficulty or risk of IA injection
- Presence of surgical hardware or other foreign body in the index joint
- Surgery or arthroscopy of the index joint within 12 months of Screening
- IA treatment of any joint with any of the following agents within 6 months of Screening:
- Any corticosteroid preparation (investigational or marketed, including FX006), any biologic agent (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy, amniotic fluid injection; investigational or marketed)
- IA treatment of the index joint with hyaluronic acid (investigational or marketed) within 6 months of Screening
- Parenteral or oral corticosteroids (investigational or marketed) within 3 months of Screening
- Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening
- Females who are pregnant or nursing or plan to become pregnant during the study; men who plan to conceive during the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FX006 32 mg
Single intra-articular (IA) injection of FX006 32 mg
|
Extended-release 32 mg FX006 IA injection
Other Names:
|
Active Comparator: TAcs 40 mg
Single intra-articular (IA) injection of TAcs 40 mg
|
Immediate-release 40mg TAcs IA injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentration of Triamcinolone Acetonide (TA) in Blood Plasma
Time Frame: 12 Weeks
|
Characterize the Pharmacokinetic Profile of FX006 and TCA IR [Time Frame: Day 1 (pre-treatment,1, 2, 3, 4, 5, 6, 8,10, and 12 hrs. post-dose) and Days 2, 3, 5, 8, 15, 22, 29, 57,and 85] For the PK analysis and individual concentration vs. time plots, a concentration that is BLOQ is assigned a value of zero if it occurs in a profile before the first measurable concentration. If a BLOQ value occurs after a measurable concentration in a profile and is followed by a value above the lower limit of quantification, then the BLOQ is treated as missing data. If a BLOQ value occurs at the end of the collection interval (after the last quantifiable concentration) it is set to zero. If two BLOQ values occur in succession after Cmax, the profile is deemed to have terminated at the first BLOQ value and any subsequent concentrations are set to zero for PK calculations |
12 Weeks
|
Total Number of Treatment Emergent Adverse Events
Time Frame: 12 Weeks
|
Analyses of adverse events (AE) were performed for events considered treatment-emergent (TE).
TE was defined as any AE with onset after administration of the 1st dose of study drug or any event present at baseline but worsened in intensity through the study.
Severity was graded by the PI using the Common Terminology Criteria for AEs Version 4.0.
Grading went from Grade 1 (Mild) to Grade 5 (Death Related to AE).
|
12 Weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Scott Kelley, MD, Pacira Pharmaceuticals, Inc
Publications and helpful links
General Publications
- Kivitz A, Mehra P, Hanson P, Kwong L, Cinar A, Lufkin J, Kelley S. A Randomized, Open-Label, Single-Dose Study to Assess Safety and Systemic Exposure of Triamcinolone Acetonide Extended-Release in Patients With Hip Osteoarthritis. Rheumatol Ther. 2022 Apr;9(2):679-691. doi: 10.1007/s40744-022-00430-3. Epub 2022 Mar 8.
- Hanson P, Kivitz A, Mehra P, Kwong L, Cinar A, Lufkin J, Kelley SD. Safety and Systemic Exposure of Triamcinolone Acetonide Following Ultrasound-Guided Intra-Articular Injection of Triamcinolone Extended-Release or Standard Triamcinolone Acetonide in Patients with Shoulder Osteoarthritis: An Open-Label, Randomized Study. Drugs R D. 2021 Sep;21(3):285-293. doi: 10.1007/s40268-021-00348-1. Epub 2021 Aug 4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Osteoarthritis
- Osteoarthritis, Hip
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Triamcinolone
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
- FX006
Other Study ID Numbers
- FX006-2017-013
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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