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Study of FX006 in Patients With Osteoarthritis of the Knee

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ClinicalTrials.gov Identifier: NCT01487161
Recruitment Status : Completed
First Posted : December 7, 2011
Results First Posted : January 12, 2018
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Flexion Therapeutics, Inc.

Brief Summary:
The purpose of this study was to evaluate the safety, efficacy and pharmacokinetics of FX006 in patients with osteoarthritis of the knee.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Drug: FX006 Drug: TCA IR Phase 2

Detailed Description:

Study FX006-2011-001 was a multi-center, randomized, double-blind, active comparator, parallel-group, single-dose study designed to assess the magnitude and duration of pain relief of three doses (10, 40, and 60 mg) of FX006, an extended-release formulation of TCA, relative to commercially-available TCA IR.

The general tolerability of a single injection of FX006 also was assessed.

Secondary objectives included exploration of the effect of FX006 on functional improvement, responder status, time to onset of pain relief, global impressions of change, and consumption of analgesic medications and evaluation of the PK profile of single injection of the three dose levels of FX006.

The study was planned to be conducted in up to 224 male and female patients ≥40 years of age with OA of the knee enrolled at 22 study centers in the US, Australia, and Canada.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 229 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013


Arm Intervention/treatment
Experimental: FX006 10 mg
Single 3 mL intra-articular (IA) injection Extended-Release Formulation
Drug: FX006
Single 3 mL intra-articular injection
Experimental: FX006 40 mg
Single 3 mL intra-articular (IA) injection Extended-Release Formulation
Drug: FX006
Single 3 mL intra-articular injection
Experimental: FX006 60 mg
Single 3mL intra-articular (IA) injection Extended-Release Formulation
Drug: FX006
Single 3 mL intra-articular injection
Active Comparator: TCA IR 40 mg
Single 1 mL intra-articular (IA) injection Immediate-Release Triamcinolone Acetonide
Drug: TCA IR
Single 1 mL intra-articular injection
Other Names:
  • Kenalog®-40 Injection
  • Kenacort-A 40
  • Triamcinolone Acetonide Crystalline Suspension (TAcs)



Primary Outcome Measures :
  1. Change From Baseline to Week 8 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg [ Time Frame: 8 weeks ]
    The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."

  2. Change From Baseline to Week 10 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg [ Time Frame: 10 weeks ]
    The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."

  3. Change From Baseline to Week 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg [ Time Frame: 12 weeks ]
    The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."


Secondary Outcome Measures :
  1. Change From Baseline to Each of Weeks 8, 10, and 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 10mg and 40 mg vs TCA IR 40 mg [ Time Frame: Weeks 8, 10 and 12 ]
    The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."

  2. Change From Baseline to Each of Weeks 1, 2, 3, 4, 5, 6, 7, 9, and 11 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score. [ Time Frame: Weeks 1-7 and Week 9 and 11 ]
    The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."

  3. WOMAC A (Pain Subscale) Change From Baseline at Week 8 [ Time Frame: 8 weeks ]
    The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  4. WOMAC A1 (Pain on Walking Question) Change From Baseline at Week 8 [ Time Frame: 8 weeks ]
    The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  5. WOMAC B (Stiffness Subscale) Change From Baseline at Week 8 [ Time Frame: 8 weeks ]
    The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  6. WOMAC C (Function Subscale) Change From Baseline at Week 8 [ Time Frame: 8 weeks ]
    The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  7. Percent of Responders According to OMERACT-OARSI Criteria at Week 8 [ Time Frame: 8 weeks ]
    Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International. Responders are defined as participants with high improvement in pain or function.

  8. Responder Status as Defined by the Proportion of Patients Achieving >50% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8 [ Time Frame: 8 weeks ]
    The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."

  9. Responder Status as Defined by the Proportion of Patients Achieving >30% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8 [ Time Frame: 8 weeks ]
    The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."

  10. Responder Status as Defined by the Proportion of Patients Achieving >20% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8 [ Time Frame: 8 weeks ]
    The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."

  11. Patient Global Impression of Change Scores at Week 8 [ Time Frame: Week 8 ]
    The Patient Global Impression of Change is a scale that aims to evaluate all aspects of participants' (patients') health and determining if there has been an improvement or not. The participant selects the one response from the response options that gives the most accurate description of his/her state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.

  12. Clinical Global Impression of Change Scores at Week 8 [ Time Frame: 8 weeks ]
    The Clinical Global Impression of Change is a scale that the clinician uses to assess the participants' global function and determine if there has been an improvement or not. The clinician selects one response from the response options that gives the most accurate description of the participant's state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.

  13. Average Weekly and Total Consumption of Rescue Medications Over 8 Weeks. [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT01487161


Locations
United States, Arizona
Tucson, Arizona, United States, 85704
United States, Pennsylvania
Duncansville, Pennsylvania, United States, 16635
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
Maroochydore, 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

Additional Information:
Responsible Party: Flexion Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01487161     History of Changes
Other Study ID Numbers: FX006-2011-001
First Posted: December 7, 2011    Key Record Dates
Results First Posted: January 12, 2018
Last Update Posted: January 18, 2018
Last Verified: January 2018

Keywords provided by Flexion Therapeutics, Inc.:
osteoarthritis
knee
pain
corticosteroid
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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action