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Pharmacokinetic and Pharmacodynamic Study of FX006 in Patients With Osteoarthritis of the Knee

Sponsor
Flexion Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01487200
Collaborator
(none)
24
Enrollment
2
Locations
4
Arms
4
Duration (Months)
12
Patients Per Site
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: FX006 10 mg
  • Drug: FX006 40 mg
  • Drug: FX006 60 mg
  • Drug: TCA IR 40
 Phase 2

Detailed Description

This study was a double-blind, randomized, parallel-group, active comparator design. The study was conducted in male and female patients ≥35 years of age with symptomatic OA of the knee.

Twenty-four (24) patients with knee OA were randomized (1:1:1:1) and treated with a single IA injection of either 10, 40, or 60 mg of FX006 or 40 mg of TCA IR.

Each patient was evaluated for a total of 6 weeks following a single IA injection. Following screening, safety, PK and pharmacodynamics (PD) were evaluated during one (1) 48-hour in-patient period (Day -1 to Day 2), two (2) 24-hour in-patient periods (Day 14-15 and Day 42-43) and seven (7) out-patient visits (Days 3, 4, 5, 8, 22, 29 and 36).

Study Design

Study Type:
Interventional
Actual Enrollment :
24 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, Active Comparator Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects (HPA Axis) of FX006 in Patients With Osteoarthritis of the Knee
Study Start Date :
Jul 1, 2012
Actual Primary Completion Date :
Nov 1, 2012
Actual Study Completion Date :
Nov 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: FX006 10mg

Single 3 mL intra-articular (IA) injection Extended-release formulation

Drug: FX006 10 mg
single 3 mL IA injection
Experimental: FX006 40mg

Single 3 mL intra-articular (IA) injection Extended-release formulation

Drug: FX006 40 mg
single 3 mL IA injection
Experimental: FX006 60 mg

Single 3 mL intra-articular (IA) injection Extended-release formulation

Drug: FX006 60 mg
single 3 mL IA injection
Active Comparator: TCA IR (40 mg)

Single 1 mL intra-articular (IA) injection Immediate-release formulation

Drug: TCA IR 40
single 1 mL IA injection
Other Names:
  • Kenalog®-40
  • Kenacort-A 40
  • Triamcinolone Acetonide Crystalline Suspension (TAcs)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in 24-hour Weighted Mean Serum Cortisol [Days 1-2, Days 14-15 (Week 2) and Days 42-43 (Week 6)]

      The primary pharmacodynamic endpoint was change from baseline (pre-dose) to Day 1-2, Day 14-15 (Week 2) and Day 42-43 (Week 6) in 24-hour weighted mean serum cortisol. This is defined as AUC over the 0-24 hour measurement period divided by 24

    2. Characterize the Pharmacokinetic Profile of FX006 and TCA IR [Day 1 (1, 2, 4, 6, 8, 12 and 24 hours post dose) and Days 3, 4, 5, 8, 15, 22, 29, 36 and 43]

      Concentrations below the limit of quantification of 50 pg/mL were treated as 0.

    Secondary Outcome Measures

    1. Change From Baseline in 24-hour Urinary Free Cortisol Excretion [Baseline to Days 1-2, Baseline to Days 14-15 (Week 2) and Baseline to Days 42-43 (Week 6)]

    2. Total 24-hour Urinary Free Cortisol Excretion [Days 1-2, Days 14-15 (Week 2) and Days 42-43 (Week 6)]

    3. Change From Baseline to Each Measured Time Point Post-dose in Morning Serum Cortisol [Baseline to Days 2, 3, 4, 5, 8, 14, 15, 22, 29, 36, 42 and 43]

      Least square mean difference against TCA IR 40 mg

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 >=35 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

    • Body mass index (BMI) ≤ 40 kg/m2

    • Willingness to abstain from use of the protocol-specified restricted medications

    Main Exclusion Criteria:

    • 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 or 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

    • History of or active malignancy, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ within 5 years

    • Insulin-dependent diabetes

    • 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

    Locations

    Site City State Country Postal Code
    1 Adelaide South Australia Australia 5000
    2 Perth Western Australia Australia

    Sponsors and Collaborators

    • Flexion Therapeutics, Inc.

    Investigators

    • Study Director: Neil Bodick, MD, Flexion Therapeutics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Flexion Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT01487200
    Other Study ID Numbers:
    • FX006-2011-002
    First Posted:
    Dec 7, 2011
    Last Update Posted:
    Dec 6, 2019
    Last Verified:
    Feb 1, 2019
    Keywords provided by Flexion Therapeutics, Inc.
    osteoarthritis
    knee
    corticosteroid
    intra-articular
    injection
    Additional relevant MeSH terms:
    Osteoarthritis
    Osteoarthritis, Knee
    Triamcinolone
    Triamcinolone Acetonide
    Triamcinolone hexacetonide
    FX006
    Triamcinolone diacetate

    Study Results

    Participant Flow

    Recruitment Details This study took place at 2 centers, both located in Australia. Enrollment for this study took approximately 1.5 months.
    Pre-assignment Detail Subjects were screened for eligibility within 14 days of being randomized
    Arm/Group Title FX006 10mg FX006 40mg FX006 60 mg TCA IR 40 mg
    Arm/Group Description 5 subjects received FX006 10 mg as a single 3 mL IA injection. 7 subjects received FX006 40 mg as a single 3 mL IA injection. 7 subjects received FX006 60 mg as a single 3 mL IA injection. 5 subjects received commercially available triamcinolone acetonide (40 mg) as a single 1 mL IA injection.
    Period Title: Overall Study
    STARTED 5 7 7 5
    COMPLETED 5 6 7 5
    NOT COMPLETED 0 1 0 0

    Baseline Characteristics

    Arm/Group Title FX006 10mg FX006 40mg FX006 60 mg TCA IR (40 mg) Total
    Arm/Group Description Single 3 mL IA injection Single 3 mL IA injection Single 3 mL IA injection Single 1 mL IA injection Total of all reporting groups
    Overall Participants 5 7 7 5 24
    Age (years) [Mean (Full Range) ]
    Mean (Full Range) [years]
    63.2
    59.3
    64.9
    63
    62.5
    Sex: Female, Male (Count of Participants)
    Female
    4
    80%
    6
    85.7%
    3
    42.9%
    3
    60%
    16
    66.7%
    Male
    1
    20%
    1
    14.3%
    4
    57.1%
    2
    40%
    8
    33.3%

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline in 24-hour Weighted Mean Serum Cortisol
    Description The primary pharmacodynamic endpoint was change from baseline (pre-dose) to Day 1-2, Day 14-15 (Week 2) and Day 42-43 (Week 6) in 24-hour weighted mean serum cortisol. This is defined as AUC over the 0-24 hour measurement period divided by 24
    Time Frame Days 1-2, Days 14-15 (Week 2) and Days 42-43 (Week 6)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title FX006 10mg FX006 40mg FX006 60 mg TCA IR 40 mg
    Arm/Group Description Single 3 mL IA injection Single 3 mL IA injection Single 3 mL IA injection Single 1 mL IA injection
    Measure Participants 5 7 7 5
    Change from BL to Days 1 to 2
    -7.7
    -42.7
    -62.2
    -59.0
    Change from BL to Days 14 to 15
    -11.1
    -33.4
    -49.5
    -19.7
    Change in BL to Days 42 to 43
    -9.0
    -18.0
    -11.8
    -4.8
    2. Primary Outcome
    Title Characterize the Pharmacokinetic Profile of FX006 and TCA IR
    Description Concentrations below the limit of quantification of 50 pg/mL were treated as 0.
    Time Frame Day 1 (1, 2, 4, 6, 8, 12 and 24 hours post dose) and Days 3, 4, 5, 8, 15, 22, 29, 36 and 43

    Outcome Measure Data

    Analysis Population Description
    PK population was to include all patients who received study drug and had at least one measurable concentration
    Arm/Group Title FX006 10mg FX006 40mg FX006 60 mg TCA IR 40 mg
    Arm/Group Description Single 3 mL IA injection Single 3 mL IA injection Single 3 mL IA injection Single 1 mL IA injection
    Measure Participants 5 7 7 5
    1 hour postdose
    140.941
    (0.4767)
    638.447
    (0.6312)
    862.574
    (0.6823)
    12268.835
    (1.4681)
    2 hours postdose
    226.058
    (0.2204)
    779.819
    (0.6778)
    1164.013
    (0.6772)
    14243.604
    (1.5643)
    4 hours postdose
    280.406
    (0.3637)
    860.476
    (0.7088)
    1251.776
    (0.7030)
    16282.659
    (1.7765)
    6 hours postdose
    261.231
    (0.4108)
    814.647
    (0.7131)
    1182.925
    (0.6952)
    14560.886
    (1.7754)
    8 hours postdose
    249.298
    (0.4640)
    748.962
    (0.7898)
    1227.658
    (0.6245)
    13543.427
    (1.7347)
    12 hours postdose
    230.506
    (0.5331)
    691.962
    (0.7456)
    1127.476
    (0.7841)
    10112.863
    (1.6684)
    Day 2 (24 hrs post dose)
    242.764
    (0.4037)
    763.568
    (0.7423)
    1309.260
    (0.5869)
    5421.894
    (1.5196)
    Day 3 (48 hrs post dose)
    233.138
    (0.3999)
    743.344
    (0.7583)
    1294.042
    (0.7645)
    2371.778
    (1.1844)
    Day 4 (72 hrs post dose)
    224.987
    (0.4904)
    675.086
    (0.6930)
    1270.953
    (0.7088)
    1310.061
    (0.8301)
    Day 5 (96 hrs post dose)
    242.533
    (0.3787)
    690.857
    (0.7292)
    1252.021
    (0.7097)
    822.243
    (0.6002)
    Day 8 (168 hrs post dose)
    185.257
    (0.5638)
    586.977
    (0.7574)
    1070.823
    (0.6322)
    235.938
    (1.0814)
    Day 15 (336 hrs post dose)
    113.002
    (0.5244)
    365.970
    (0.7325)
    718.787
    (0.5587)
    0.000
    (0.000)
    Day 22 (504 hrs post dose)
    0.000
    (0.000)
    238.529
    (0.7026)
    521.843
    (0.4563)
    0.000
    (0.000)
    Day 29 (672 hrs post dose)
    0.000
    (0.000)
    189.422
    (0.6089)
    369.683
    (0.4589)
    0.000
    (0.000)
    Day 36 (840 hrs post dose)
    0.000
    (0.000)
    0.000
    (0.000)
    246.176
    (0.3844)
    0.000
    (0.000)
    Day 43 (1008 hrs post dose)
    0.000
    (0.000)
    138.660
    (0.6253)
    187.435
    (0.3924)
    0.000
    (0.000)
    3. Secondary Outcome
    Title Change From Baseline in 24-hour Urinary Free Cortisol Excretion
    Description
    Time Frame Baseline to Days 1-2, Baseline to Days 14-15 (Week 2) and Baseline to Days 42-43 (Week 6)

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set (FAS) includes all observations from all patients who received a dose of study drug and provided a baseline observation and at least one post baseline observation.
    Arm/Group Title FX006 10mg FX006 40mg FX006 60 mg TCA IR 40 mg
    Arm/Group Description Single 3 mL IA injection Single 3 mL IA injection Single 3 mL IA injection Single 1 mL IA injection
    Measure Participants 5 7 7 5
    Day 1 to 2
    47.9
    -43.8
    -50.1
    -58.5
    Day 14 to 15
    13.0
    -42.4
    -59.0
    -14.7
    Day 42 to 43
    7.7
    -38.3
    -13.1
    -21.3
    4. Secondary Outcome
    Title Total 24-hour Urinary Free Cortisol Excretion
    Description
    Time Frame Days 1-2, Days 14-15 (Week 2) and Days 42-43 (Week 6)

    Outcome Measure Data

    Analysis Population Description
    FAS includes all observations from all patients who received a dose of study drug and provided a baseline observation and at least one post baseline observation.
    Arm/Group Title FX006 10mg FX006 40mg FX006 60 mg TCA IR 40 mg
    Arm/Group Description Single 3 mL IA injection Single 3 mL IA injection Single 3 mL IA injection Single 1 mL IA injection
    Measure Participants 5 7 7 5
    Day 1 to 2
    75.66
    (1.112)
    29.94
    (0.770)
    29.36
    (0.490)
    18.77
    (0.289)
    Day 14 to 15
    57.14
    (0.842)
    30.91
    (0.590)
    26.46
    (0.925)
    36.22
    (0.962)
    Day 42 to 43
    55.74
    (0.715)
    34.62
    (0.557)
    51.16
    (0.499)
    36.38
    (0.626)
    5. Secondary Outcome
    Title Change From Baseline to Each Measured Time Point Post-dose in Morning Serum Cortisol
    Description Least square mean difference against TCA IR 40 mg
    Time Frame Baseline to Days 2, 3, 4, 5, 8, 14, 15, 22, 29, 36, 42 and 43

    Outcome Measure Data

    Analysis Population Description
    The full analysis set will include all observations from all patients who received any dose of FX006 and provide a baseline observation and at least one post baseline observation.
    Arm/Group Title FX006 10mg FX006 40mg FX006 60 mg TCA IR 40 mg
    Arm/Group Description Single 3 mL IA injection Single 3 mL IA injection Single 3 mL IA injection Single 1 mL IA injection of commercially available triamcinolone acetonide
    Measure Participants 5 7 7 5
    Day 2
    -30.2
    -42.3
    -78.2
    -85.4
    Day 3
    -24.9
    -40.8
    -80.2
    -86.2
    Day 4
    -13.9
    -37.1
    -77.2
    -73.1
    Day 5
    -12.4
    -35.1
    -73.0
    -49.8
    Day 8
    -29.8
    -37.4
    -61.7
    -8.6
    Day 14
    -7.6
    -35.5
    -40.4
    -27.3
    Day 15
    -24.4
    -28.1
    -46.4
    -8.3
    Day 22
    3.3
    -28.5
    -14.4
    -11.3
    Day 29
    -4.5
    -21.1
    -6.3
    0.8
    Day 36
    -6.4
    -19.5
    -3.0
    11.7
    Day 42
    -18.3
    -27.0
    -19.1
    -21.4
    Day 43
    -22.1
    -14.9
    -13.4
    3.0

    Adverse Events

    Time Frame Adverse Events were collected from post injection on Day 1 through Day 43.
    Adverse Event Reporting Description
    Arm/Group Title FX006 10mg FX006 40mg FX006 60 mg TCA IR 40 mg
    Arm/Group Description Single 3 mL IA injection Single 3 mL IA injection Single 3 mL IA injection Single 1 mL IA injection of commercially available triamcinolone acetonide
    All Cause Mortality
    FX006 10mg FX006 40mg FX006 60 mg TCA IR 40 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%)
    Serious Adverse Events
    FX006 10mg FX006 40mg FX006 60 mg TCA IR 40 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/5 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%)
    Other (Not Including Serious) Adverse Events
    FX006 10mg FX006 40mg FX006 60 mg TCA IR 40 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/5 (80%) 7/7 (100%) 6/7 (85.7%) 5/5 (100%)
    Cardiac disorders
    Palpitations 1/5 (20%) 1 0/7 (0%) 0 0/7 (0%) 0 0/5 (0%) 0
    Gastrointestinal disorders
    Dental caries 1/5 (20%) 1 0/7 (0%) 0 0/7 (0%) 0 0/5 (0%) 0
    Diarrhoea 1/5 (20%) 1 0/7 (0%) 0 0/7 (0%) 0 0/5 (0%) 0
    Nausea 1/5 (20%) 1 0/7 (0%) 0 0/7 (0%) 0 0/5 (0%) 0
    Vomiting 1/5 (20%) 1 0/7 (0%) 0 0/7 (0%) 0 0/5 (0%) 0
    General disorders
    Adverse drug reaction 0/5 (0%) 0 1/7 (14.3%) 1 0/7 (0%) 0 0/5 (0%) 0
    Catheter site haematoma 1/5 (20%) 1 1/7 (14.3%) 1 1/7 (14.3%) 1 2/5 (40%) 2
    Catheter site related reaction 0/5 (0%) 0 0/7 (0%) 0 0/7 (0%) 0 1/5 (20%) 1
    Feeling hot 0/5 (0%) 0 1/7 (14.3%) 1 0/7 (0%) 0 0/5 (0%) 0
    Injection site erythema 0/5 (0%) 0 1/7 (14.3%) 1 0/7 (0%) 0 0/5 (0%) 0
    Injection site pain 1/5 (20%) 1 1/7 (14.3%) 1 0/7 (0%) 0 0/5 (0%) 0
    Vessel puncture site haematoma 2/5 (40%) 2 0/7 (0%) 0 1/7 (14.3%) 1 1/5 (20%) 1
    Infections and infestations
    Nasopharyngitis 0/5 (0%) 0 0/7 (0%) 0 0/7 (0%) 0 1/5 (20%) 1
    Sinusitis 0/5 (0%) 0 1/7 (14.3%) 1 0/7 (0%) 0 0/5 (0%) 0
    Upper respiratory tract infection 0/5 (0%) 0 1/7 (14.3%) 1 1/7 (14.3%) 1 0/5 (0%) 0
    Injury, poisoning and procedural complications
    Contusion 1/5 (20%) 1 2/7 (28.6%) 2 2/7 (28.6%) 2 0/5 (0%) 0
    Joint injury 1/5 (20%) 1 0/7 (0%) 0 0/7 (0%) 0 0/5 (0%) 0
    Joint sprain 0/5 (0%) 0 0/7 (0%) 0 1/7 (14.3%) 1 0/5 (0%) 0
    Laceration 0/5 (0%) 0 0/7 (0%) 0 1/7 (14.3%) 1 0/5 (0%) 0
    Post-traumatic pain 0/5 (0%) 0 2/7 (28.6%) 2 0/7 (0%) 0 0/5 (0%) 0
    Investigations
    Blood pressure increased 1/5 (20%) 1 0/7 (0%) 0 0/7 (0%) 0 0/5 (0%) 0
    Metabolism and nutrition disorders
    Diabetes mellitus 0/5 (0%) 0 0/7 (0%) 0 0/7 (0%) 0 1/5 (20%) 1
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/5 (20%) 1 3/7 (42.9%) 3 0/7 (0%) 0 0/5 (0%) 0
    Arthropathy 0/5 (0%) 0 0/7 (0%) 0 0/7 (0%) 0 1/5 (20%) 1
    Joint stiffness 1/5 (20%) 1 0/7 (0%) 0 1/7 (14.3%) 1 1/5 (20%) 1
    Muscle spasms 0/5 (0%) 0 1/7 (14.3%) 1 2/7 (28.6%) 2 1/5 (20%) 1
    Musculoskeletal Pain 0/5 (0%) 0 0/7 (0%) 0 1/7 (14.3%) 1 1/5 (20%) 1
    Myalgia 0/5 (0%) 0 0/7 (0%) 0 1/7 (14.3%) 1 0/5 (0%) 0
    Spinal osteoarthritis 0/5 (0%) 0 0/7 (0%) 0 1/7 (14.3%) 1 0/5 (0%) 0
    Nervous system disorders
    Dizziness 1/5 (20%) 1 0/7 (0%) 0 0/7 (0%) 0 1/5 (20%) 1
    Headache 1/5 (20%) 1 3/7 (42.9%) 3 3/7 (42.9%) 3 1/5 (20%) 1
    Lethargy 1/5 (20%) 1 0/7 (0%) 0 0/7 (0%) 0 0/5 (0%) 0
    Syncope 0/5 (0%) 0 1/7 (14.3%) 1 0/7 (0%) 0 0/5 (0%) 0
    Psychiatric disorders
    Anxiety 1/5 (20%) 1 0/7 (0%) 0 0/7 (0%) 0 0/5 (0%) 0
    Insomnia 0/5 (0%) 0 0/7 (0%) 0 0/7 (0%) 0 1/5 (20%) 1
    Libido decreased 0/5 (0%) 0 0/7 (0%) 0 1/7 (14.3%) 1 0/5 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Cough 0/5 (0%) 0 1/7 (14.3%) 1 0/7 (0%) 0 0/5 (0%) 0
    Oropharyngeal pain 1/5 (20%) 1 0/7 (0%) 0 0/7 (0%) 0 1/5 (20%) 1
    Wheezing 0/5 (0%) 0 0/7 (0%) 0 1/7 (14.3%) 1 0/5 (0%) 0
    Skin and subcutaneous tissue disorders
    Night Sweats 1/5 (20%) 1 1/7 (14.3%) 1 0/7 (0%) 0 0/5 (0%) 0
    Pruritus 0/5 (0%) 0 1/7 (14.3%) 1 0/7 (0%) 0 0/5 (0%) 0
    Vascular disorders
    Flushing 0/5 (0%) 0 1/7 (14.3%) 1 0/7 (0%) 0 0/5 (0%) 0
    Hypertension 0/5 (0%) 0 0/7 (0%) 0 1/7 (14.3%) 1 0/5 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Results Point of Contact

    Name/Title Scott Kelley, Chief Medical Officer
    Organization Flexion Therapeutics
    Phone 781-305-7142
    Email skelley@flexiontherapeutics.com
    Responsible Party:
    Flexion Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT01487200
    Other Study ID Numbers:
    • FX006-2011-002
    First Posted:
    Dec 7, 2011
    Last Update Posted:
    Dec 6, 2019
    Last Verified:
    Feb 1, 2019