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Study to Compare Exposure of TA Following Administration of FX006 or TAcs in Patients With OA of the Shoulder or Hip

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ClinicalTrials.gov Identifier: NCT03382262
Recruitment Status : Completed
First Posted : December 22, 2017
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
Flexion Therapeutics, Inc.

Brief Summary:
This is an open-label study to compare systemic exposure to triamcinolone acetonide following a dose of extended-release FX006 or immediate-release TAcs (triamcinolone acetonide suspension) in patients with osteoarthritis of the shoulder (glenohumeral joint) or hip

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Shoulder Osteoarthritis of the Hip Drug: FX006 32 mg Drug: TAcs 40 mg Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 18, 2017
Actual Primary Completion Date : October 9, 2018
Actual Study Completion Date : October 9, 2018


Arm Intervention/treatment
Experimental: FX006 32 mg
Single intra-articular (IA) injection of FX006 32 mg
Drug: FX006 32 mg
Extended-release 32 mg FX006 IA injection
Other Name: Zilretta

Active Comparator: TAcs 40 mg
Single intra-articular (IA) injection of TAcs 40 mg
Drug: TAcs 40 mg
Immediate-release 40mg TAcs IA injection
Other Names:
  • Kenalog®-40 Injection
  • Triamcinolone Acetonide Crystalline Suspension (TAcs)
  • TCA-IR 40




Primary Outcome Measures :
  1. Measure the concentration of triamcinolone acetonide (TA) in blood plasma [ Time Frame: 12 Weeks ]
  2. Incidence of treatment emergent adverse events [ Time Frame: 12 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03382262


Locations
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United States, California
TriWest Research Associates, LLC
El Cajon, California, United States, 92020
Biosolutions Clinical Research Center
La Mesa, California, United States, 91942
Artemis Institute for Clinical Research
San Diego, California, United States, 92103
LA Biomed at Harbor-UCLA Medical Center
Torrance, California, United States, 90509
United States, New York
Rochester Clinical Research
Rochester, New York, United States, 14609
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Sponsors and Collaborators
Flexion Therapeutics, Inc.
Investigators
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Study Director: Scott Kelley, MD Flexion Therapeutics, Inc.

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Responsible Party: Flexion Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03382262     History of Changes
Other Study ID Numbers: FX006-2017-013
First Posted: December 22, 2017    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Flexion Therapeutics, Inc.:
Osteoarthritis
Shoulder
Hip
Pain
Intra-articular
Injection
Corticosteroid

Additional relevant MeSH terms:
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Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action