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Study of FX006 in Patients With Osteoarthritis of the Knee

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Flexion Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01487161
First received: December 5, 2011
Last updated: September 16, 2013
Last verified: September 2013

December 5, 2011
September 16, 2013
June 2012
May 2013   (final data collection date for primary outcome measure)
  • 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 ]
  • Change from Baseline to Week 8 in weekly average 24-hour average pain intensity [ Time Frame: at 8 weeks ] [ Designated as safety issue: No ]
  • Incidence of treatment emergent adverse events [ Time Frame: through 12 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01487161 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change from Baseline to Weeks 1, 2, 3, 4, 5, 6, 7, 9, 10, 11 and 12 in weekly average 24-hour average pain intensity. [ 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 assessment scores [ Time Frame: at 1, 2, 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • Average weekly consumption of analgesic 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 ]
Not Provided
Not Provided
 
Study of FX006 in Patients With Osteoarthritis of the Knee
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

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis of the Knee
  • Drug: FX006
    Single intra-articular injection
  • Drug: Commercially available triamcinolone acetonide
    Single intra-articular injection
  • Experimental: FX006 10 mg
    Intervention: Drug: FX006
  • Experimental: FX006 40 mg
    Intervention: Drug: FX006
  • Experimental: FX006 60 mg
    Intervention: Drug: FX006
  • Active Comparator: commercially available triamcinolone acetonide (40 mg)
    Intervention: Drug: Commercially available triamcinolone acetonide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
229
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada
 
NCT01487161
FX006-2011-001
No
Flexion Therapeutics, Inc.
Flexion Therapeutics, Inc.
Not Provided
Study Director: Neil Bodick, MD, PhD Flexion Therapeutics
Flexion Therapeutics, Inc.
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP