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    Summary
    EudraCT Number:2010-022976-29
    Sponsor's Protocol Code Number:FX005-2010-001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-10-20
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2010-022976-29
    A.3Full title of the trial
    A Double-Blind, Randomised, Placebo-Controlled, Two-Phase Study (a Single Ascending Dose Phase Followed by a Proof of Concept Phase) to Assess the Safety, Efficacy and Pharmacokinetics of FX005 (50:50 PLGA) Microspheres for the Treatment of Pain in Osteoarthritis of the Knee.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Not applicable
    A.4.1Sponsor's protocol code numberFX005-2010-001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFlexion Therapeutics, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFlexion Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharmaNet Sp. Z o. o. - Poland
    B.5.2Functional name of contact pointMarta Skoczylas-Pietrzyk
    B.5.3 Address:
    B.5.3.1Street AddressUI. Koszykowa 54
    B.5.3.2Town/ cityWarsaw
    B.5.3.3Post code675
    B.5.3.4CountryPoland
    B.5.4Telephone number+48 22 630 87 27
    B.5.5Fax number+48 22 630 8701
    B.5.6E-mailMSkoczylas@pharmanet.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFX005 (50:50 PLGA) Microspheres
    D.3.2Product code FX005 (50:50 PLGA) Microspheres
    D.3.4Pharmaceutical form Powder for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeFX005
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to mg
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFX005 (50:50 PLGA) Microspheres
    D.3.2Product code FX005 (50:50 PLGA) Microspheres
    D.3.4Pharmaceutical form Powder for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeFX005
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10.5 to mg
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for injection
    D.8.4Route of administration of the placeboIntraarticular use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntraarticular use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for injection
    D.8.4Route of administration of the placeboIntraarticular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of Pain in osteoarthritis of the knee
    E.1.1.1Medical condition in easily understood language
    Not applicable
    E.1.1.2Therapeutic area Body processes [G] - Bones and nerves physological processes [G11]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    SINGLE ASCENDING DOSE PHASE - Primary objective
    The primary objective of the SAD phase of this study is to assess the safety and tolerability of single doses of the FX005 microspheres in patients with osteoarthritis of the knee
    PROOF OF CONCEPT PHASE - Primary Objectives
    The primary objectives of the PoC Phase of this study are:
    • to asses the safety and tolerability of a single dose of FX005 microspheres in patients with osteoarthritis of the knee, and
    •to assess the analgesic effect of single doses of FX005 microspheres in patients with osteoarthritis of the knee
    E.2.2Secondary objectives of the trial
    SINGLE ASCENDING DOSE PHASE - Secondary Objective
    The secondary objectives of the PoC phase of this study are:
    •to characterize the single dose pharmacokinetic profiles of
    FX005 microspheres
    Proof of Concept Phase - The secondary objectives of the PoC Phase of this study are:
    •to characterize the single dose pharmacokinetic profiles of
    FX005 microspheres
    •to explore the effect of FX005 microspheres on:
    o functional improvement
    o intermittent and constant osteoarthritis pain
    o patient global assessment of disease status
    o clinical observer global assessment of the disease status
    o OMERACT-OARSI responder status
    o consumption of analgesic medications
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Written consent to participate in the study
    •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 osteoarthritis of the knee for at least 6 months according to American College of Rheumatology (ACR) 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 at Screening
    •Radiographic evidence of osteoarthritis in the tibiofemoral compartment of the index knee (Kellgren-Lawrence grades II or III) within 6 months prior to Screening or at Screening (PoC)
    • Score of 2 or higher for at least one of the five WOMAC A subscale questions fo the index knee at Screening (SAD only)
    •Index knee pain on most days (>15) over the last month (PoC only)
    •Mean score for the WOMAC A subscale (Likert 3.1) between 2.0 and 3.5 for the index knee at Screening and Baseline (PoC)
    •Score of 2-3 for the WOMAC A1 score (pain on walking) for the index knee at Screening and Baseline (PoC)
    •If bilateral OA exists, the mean score for the WOMAC A subscale for the contralateral knee must be less than the mean score for the WOMAC A subscale for the index knee at Screening and Baseline (PoC only)
    •Body mass index (BMI) ≤ 40 kg/m2
    •Willingness to abstain from use of topical pain therapies (e.g., NSAIDS, capsaicin, lidocain patches, heat patches), intra-articular corticosteroids and intra- articular viscosupplementation during the study
    Willingness to abstain from NSAIDs narcotics and system corticosteroids during the study (PoC)
    •Willingness to abstain from the use of the only permitted rescue medication (acetaminophen/paracetamol) for 48 hours prior to the in-clinic and all out patient visits with the exception of Visit 1 (Screening) (PoC)
    •No clinically significant results at Screening (clinical significance of values or findings outside of normal ranges will be determined by the Principal Investigator)
    E.4Principal exclusion criteria
    Disease-related criteria:
    •Kellgren-Lawrence Grade 0, I or IV radiographic stage of the index knee (PoC)
    •Clinically apparent tense effusion in index knee
    •Ipsilateral hip osteoarthritis (PoC)
    •Fibromyalgia, chronic pain syndrome or other concurrent medical or arthritic conditions which could interfere with evaluation of the index knee (PoC)
    •History of Reiter’s syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis
    •Presence of surgical hardware or other foreign body in the index joint
    •Pain in any other area of the lower extremities or back that is equal to or greater than the index knee pain
    •Clinical signs and symptoms of active knee infection or crystal disease

    Previous or concomitant OA treatment-related criteria:
    •Intra-articular corticosteroid within 3 months of Screening
    •Intra-articular hyaluronic acid within 6 months of Screening
    •Other intra-articular therapy within 3 months of Screening
    •Systemic corticosteroid within 2 weeks of Screening (PoC)
    •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
    Patient-related criteria:
    •Clinically significant cardiac disease as judged by the Principal Investigator (e.g., uncontrolled hypertension).
    •Screening on Baseline 12-lead ECG demonstrating QTC > 450 msec in male patients and > 470 msec in female patients (Goldberg et al., 2006) or any clinically significant ECG abnormality as judged by the Principal Investigator .
    •History of malignancy, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ
    •Known or clinically suspected infection with human immunodeficiency virus (HIV), hepatitis C or B viruses
    •History of latent or active tuberculosis
    •History of positive TB test or a positive screening TST defined as 5+ induration
    •Lived in or visited a country where TB is endemic in the 8 weeks prior to Screening
    •Other serious, non-malignant, significant, acute or chronic medical (e.g.. uncontrolled diabetes) or active psychiatric illness that, in the judgment of the Principal Investigator, could compromise patient safety, limit the patient’s ability to complete the study, and/or compromise the objectives of the study
    •Increased predisposition for the development of infections
    •Skin breakdown at the knee where the injection would take place
    •History of drug or alcohol dependence in the past 3 years
    •Women who are pregnant, nursing or likely to become pregnant during the time of the study
    •Women of child-bearing potential (not surgically sterile or post-menopausal for at least 1 year as documented in medical history) not using effective contraception (e.g. condom, oral contraceptives, diaphram or cervical cap , intrauterine device, tubal ligation or other surgical procedure)
    •Known sensitivity to ethyl chloride (SAD)
    •Known sensitivity to acetaminophen / paracetamol
    •Use of any investigational drug or device within 30 days of study start
    •Use of any investigational biologic within 60 days of study start
    E.5 End points
    E.5.1Primary end point(s)
    •WOMAC A (pain subscale) change from baseline at 4 weeks
    E.5.1.1Timepoint(s) of evaluation of this end point
    June 2011
    E.5.2Secondary end point(s)
    •Characterize the single dose pharmacokinetic profiles of FX005 microspheres
    E.5.2.1Timepoint(s) of evaluation of this end point
    December 2011/Jan 2012
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    SAD Phase:Ascending Dose, PoC Phase: parallel group
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Germany
    Spain
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last patient, last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months15
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months15
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 128
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 128
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 128
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    No further treatment other than standard of care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-03-07
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