Study of FX006 vs Normal Saline in Patients With Osteoarthritis of the Knee
NCT ID: NCT02116972
Last Updated: 2024-01-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
310 participants
INTERVENTIONAL
2014-04-30
2015-11-30
Brief Summary
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Detailed Description
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Approximately 300 patients with OA of the knee were randomized, using a centralized randomization procedure, to 1 of 3 treatment groups (1:1:1) and treated with a single IA injection of:
* 16 mg FX006,
* 32 mg FX006, or
* normal saline (placebo).
Each patient was evaluated for a total of 24 weeks following a single IA injection. Following screening, safety and efficacy were evaluated at 7 out-patient visits (Days 1 \[Baseline\], Weeks 4, 8, 12, 16, 20, and 24).
The study was expected to enroll over approximately 6 to 7 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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FX006 16 mg
Single 5 mL intra-articular (IA) injection Extended-release formulation
FX006 16 mg
Single 5 mL IA injection
FX006 32 mg
Single 5 mL intra-articular (IA) injection Extended-release formulation
FX006 32 mg
Single 5 mL IA injection
Placebo
Normal Saline Single 5 mL intra-articular (IA) injection
Placebo
Single 5 mL IA injection
Interventions
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FX006 32 mg
Single 5 mL IA injection
Placebo
Single 5 mL IA injection
FX006 16 mg
Single 5 mL IA injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female \>=40 years of age
* Has documented diagnosis of OA of the index knee made at least 6 months prior to Screening
* Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA
* Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee per Screening X-ray
* Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)
* Body mass index (BMI) ≤ 40 kg/m2
* Willingness to abstain from use of restricted medications
Exclusion Criteria
* Fibromyalgia, chronic pain syndrome or other concurrent medical or arthritic conditions which could interfere with the evaluation of the index knee
* History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis
* History of arthritides due to crystals (e.g., gout, pseudogout)
* History or clinical signs and symptoms of infection in the index joint
* Knee pain that is not clinically attributable to OA of the knee (e.g., radicular low back pain and hip pain that is referred to the knee that could cause misclassification)
* Pain in any other area of the lower extremities or back that is equal to or greater than the index knee pain
* IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening
* IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
* Intramuscular (IM) corticosteroids (investigational or marketed) within 3 months of Screening
* Oral corticosteroids (investigational or marketed) within 1 month of Screening
* Inhaled, intranasal and topical corticosteroids (investigational or marketed) within 2 weeks of Screening
* Any other IA investigational drug/biologic within 6 months of Screening
* Prior use of FX006
* Women of child-bearing potential not using effective contraception or who are pregnant or nursing
40 Years
ALL
No
Sponsors
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Pacira Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Neil Bodick, MD
Role: STUDY_DIRECTOR
Flexion Therapeutics
Locations
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Anniston, Alabama, United States
Birmingham, Alabama, United States
Mobile, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Hot Springs, Arkansas, United States
Anaheim, California, United States
Canoga Park, California, United States
El Cajon, California, United States
Los Angeles, California, United States
North Hollywood, California, United States
San Diego, California, United States
Stamford, Connecticut, United States
DeLand, Florida, United States
Fort Lauderdale, Florida, United States
Orlando, Florida, United States
Pinellas Park, Florida, United States
Tampa, Florida, United States
Marietta, Georgia, United States
Evansville, Indiana, United States
Paducah, Kentucky, United States
Wheaton, Maryland, United States
New Bedford, Massachusetts, United States
Troy, Michigan, United States
Kansas City, Missouri, United States
Las Vegas, Nevada, United States
Albuquerque, New Mexico, United States
New York, New York, United States
Rochester, New York, United States
Raleigh, North Carolina, United States
Oklahoma City, Oklahoma, United States
Altoona, Pennsylvania, United States
Duncansville, Pennsylvania, United States
Mt. Pleasant, South Carolina, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Victoria, Texas, United States
Danville, Virginia, United States
Kitchener, Ontario, Canada
Sarnia, Ontario, Canada
Toronto, Ontario, Canada
Windsor, Ontario, Canada
Québec, , Canada
Countries
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References
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Conaghan PG, Cohen SB, Berenbaum F, Lufkin J, Johnson JR, Bodick N. Brief Report: A Phase IIb Trial of a Novel Extended-Release Microsphere Formulation of Triamcinolone Acetonide for Intraarticular Injection in Knee Osteoarthritis. Arthritis Rheumatol. 2018 Feb;70(2):204-211. doi: 10.1002/art.40364. Epub 2017 Dec 20.
Other Identifiers
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FX006-2014-006
Identifier Type: -
Identifier Source: org_study_id
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