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Study of FX006 in Patients With Osteoarthritis of the Knee

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Flexion Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01487161
First received: December 5, 2011
Last updated: February 22, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of the study is to evaluate the safety, efficacy and pharmacokinetics of FX006 in patients with osteoarthritis of the knee.


Condition Intervention Phase
Osteoarthritis of the Knee
 Drug: FX006
Drug: Commercially available triamcinolone acetonide
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Parallel Group, Dose-Ranging Study Comparing FX006 to Commercially Available Triamcinolone Acetonide Injectable Suspension in Patients With Osteoarthritis of the Knee

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Flexion Therapeutics, Inc.:

Primary Outcome Measures:
  • Change from Baseline to each of Weeks 8, 10 and 12 in weekly mean of the average daily (24-hour) pain intensity score. [ Time Frame: at 8, 10 and 12 weeks ] [ Designated as safety issue: No ]
  • Incidence of treatment emergent adverse events [ Time Frame: through 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from Baseline to each of Weeks 1, 2, 3, 4, 5, 6, 7, 9 and 11 in weekly mean of the average (24-hour) pain intensity score. [ Time Frame: weekly through 12 weeks ] [ Designated as safety issue: No ]
  • Time of onset of pain relief [ Time Frame: weekly through 12 weeks ] [ Designated as safety issue: No ]
  • Continuous responder at each study week [ Time Frame: weekly through 12 weeks ] [ Designated as safety issue: No ]
  • WOMAC A (pain subscale) change from Baseline [ Time Frame: at 1, 2, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • WOMAC B (stiffness subscale) change from Baseline [ Time Frame: at 1, 2, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • WOMAC C (function subscale) change from Baseline [ Time Frame: at 1, 2, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • WOMAC (total) change from Baseline [ Time Frame: at 1, 2, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • Percent of responders (defined as patients with high improvement in pain or function) according to OMERACT-OARSI criteria [ Time Frame: at 1, 2, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • Change in patient's and clinical observer's global impression of change scores [ Time Frame: at 1, 2, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • Average weekly and total consumption of rescue medications [ Time Frame: weekly through 12 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetic profile [ Time Frame: through 12 weeks ] [ Designated as safety issue: No ]
  • WOMAC A1 (pain on walking question) change from Baseline [ Time Frame: at 1, 2, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 224
Study Start Date: June 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FX006 10 mg Drug: FX006
Single intra-articular injection
Experimental: FX006 40 mg Drug: FX006
Single intra-articular injection
Experimental: FX006 60 mg Drug: FX006
Single intra-articular injection
Active Comparator: commercially available triamcinolone acetonide (40 mg) Drug: Commercially available triamcinolone acetonide
Single intra-articular injection

Detailed Description:

This study will be a multi-center, randomized, double-blind, active comparator, parallel-group, single dose design.

Up to 224 patients with knee OA will be randomized to be treated with a single IA injection of either 10, 40, or 60 mg of FX006 or 40 mg of Kenalog-40.

Each patient will be evaluated for a total of 12 weeks following a single IA injection. Following screening, safety and efficacy and PK will be evaluated at 7 out-patient visits (Days 1 [Baseline], 2, 8, 15, 29, 57 and 85).

Analgesic effect will be assessed using weekly average of daily (24 hour) pain intensity score, Western Ontario & McMaster University Osteoarthritis Index (WOMAC) and patient and clinical global impression of change.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
  • Male or female >=40 years of age
  • Diagnosis of unilateral or bilateral OA of the knee for at least 6 months prior to Screening with confirmation of OA according to American College of Rheumatology Criteria for Classification of Idiopathic OA of the Knee (clinical and radiological) based on an X-ray performed within 6 months prior to Screening or during the Screening period
  • 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

Main Exclusion Criteria

  • Ipsilateral hip OA
  • 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 of infection in the index joint
  • Clinical signs and symptoms of active knee infection or crystal disease of the index knee
  • Presence of surgical hardware or other foreign body in the index knee
  • Unstable joint (such as a torn anterior cruciate ligament)
  • 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
  • Oral, inhaled and intranasal corticosteroids (investigational or marketed) within 1 month of Screening
  • Prior arthroscopic or open surgery of the index knee within 12 months of Screening
  • Planned/anticipated surgery of the index knee during the study period
  • Active or history of malignancy within the last 5 years, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ
  • Insulin-dependent diabetes
  • Active psychiatric disorder including psychosis and major depressive disorder
  • History of or active Cushing's syndrome
  • Any other clinically significant acute or chronic medical conditions (e.g., uncontrolled diabetes)
  • Skin breakdown at the knee where the injection would take place
  • Women of child-bearing potential not using effective contraception or who are pregnant or nursing
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487161

Locations
United States, Arizona
Tucson, Arizona, United States
United States, Pennsylvania
Duncansville, Pennsylvania, United States
Australia, New South Wales
Broadmeadow, New South Wales, Australia
Kogarah, New South Wales, Australia
St. Leonards, New South Wales, Australia
Wollongong, New South Wales, Australia
Australia, Queensland
Kippa-Ring, Queensland, Australia
Maroochyndore, Queensland, Australia
Sherwood, Queensland, Australia
Australia, Victoria
Clayton, Victoria, Australia
Malvern East, Victoria, Australia
Canada, Nova Scotia
Halifax, Nova Scotia, Canada
Canada, Ontario
Etobicoke, Ontario, Canada
Newmarket, Ontario, Canada
Sarnia, Ontario, Canada
St. Catherine's, Ontario, Canada
Thornhill, Ontario, Canada
Waterloo, Ontario, Canada
Windsor, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Sainte-Foy, Quebec, Canada
Sponsors and Collaborators
Flexion Therapeutics, Inc.
Investigators
Study Director: Neil Bodick, MD, PhD Flexion Therapeutics
  More Information

No publications provided

Responsible Party: Flexion Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01487161     History of Changes
Other Study ID Numbers: FX006-2011-001
Study First Received: December 5, 2011
Last Updated: February 22, 2013
Health Authority: Canada: Health Canada
Australia: Therapeutics Goods Administration (TGA)
United States: Food and Drug Administration

Keywords provided by Flexion Therapeutics, Inc.:
Osteoarthritis
Knee
pain
 steroid
intra-articular
injection

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

ClinicalTrials.gov processed this record on June 18, 2013