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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.

December 5, 2011
December 7, 2011
November 2, 2017
January 12, 2018
January 18, 2018
June 2012
April 2013   (Final data collection date for primary outcome measure)
  • 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."
  • 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."
  • 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."
  • Change from Baseline to Week 8 in weekly average 24-hour average pain intensity [ Time Frame: at 8 weeks ]
  • Incidence of treatment emergent adverse events [ Time Frame: through 12 weeks ]
Complete list of historical versions of study NCT01487161 on ClinicalTrials.gov Archive Site
  • 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."
  • 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."
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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."
  • 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."
  • 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."
  • 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.
  • 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.
  • Average Weekly and Total Consumption of Rescue Medications Over 8 Weeks. [ Time Frame: 8 weeks ]
  • 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 ]
  • Time of onset of pain relief [ Time Frame: weekly through 12 weeks ]
  • Continuous responder at each study week [ Time Frame: weekly through 12 weeks ]
  • WOMAC A (pain subscale) change from Baseline [ Time Frame: at 1, 2, 4, 8 and 12 weeks ]
  • WOMAC B (stiffness subscale) change from Baseline [ Time Frame: at 1, 2, 4, 8 and 12 weeks ]
  • WOMAC C (function subscale) change from Baseline [ Time Frame: at 1, 2, 4, 8 and 12 weeks ]
  • WOMAC (total) change from Baseline [ Time Frame: at 1, 2, 4, 8 and 12 weeks ]
  • 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 ]
  • Change in patient's and clinical observer's global assessment scores [ Time Frame: at 1, 2, 4, 8 and 12 weeks ]
  • Average weekly consumption of analgesic medications [ Time Frame: weekly through 12 weeks ]
  • Pharmacokinetic profile [ Time Frame: through 12 weeks ]
  • WOMAC A1 (pain on walking question) change from Baseline [ Time Frame: at 1, 2, 4, 8 and 12 weeks ]
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 this study was to evaluate the safety, efficacy and pharmacokinetics of FX006 in patients with osteoarthritis of the knee.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis of the Knee
  • Drug: FX006
    Single 3 mL intra-articular injection
  • Drug: TCA IR
    Single 1 mL intra-articular injection
    Other Names:
    • Kenalog®-40 Injection
    • Kenacort-A 40
    • Triamcinolone Acetonide Crystalline Suspension (TAcs)
  • Experimental: FX006 10 mg
    Single 3 mL intra-articular (IA) injection Extended-Release Formulation
    Intervention: Drug: FX006
  • Experimental: FX006 40 mg
    Single 3 mL intra-articular (IA) injection Extended-Release Formulation
    Intervention: Drug: FX006
  • Experimental: FX006 60 mg
    Single 3mL intra-articular (IA) injection Extended-Release Formulation
    Intervention: Drug: FX006
  • Active Comparator: TCA IR 40 mg
    Single 1 mL intra-articular (IA) injection Immediate-Release Triamcinolone Acetonide
    Intervention: Drug: TCA IR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
229
152
April 2013
April 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
Sexes Eligible for Study: All
40 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   United States
 
 
NCT01487161
FX006-2011-001
No
Not Provided
Not Provided
Flexion Therapeutics, Inc.
Flexion Therapeutics, Inc.
Not Provided
Study Director: Neil Bodick, MD, PhD Flexion Therapeutics
Flexion Therapeutics, Inc.
January 2018

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