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    Summary
    EudraCT Number:2009-016457-18
    Sponsor's Protocol Code Number:E05-CL-3001
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-05-18
    Trial results View 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 ConcernedIreland - HPRA
    A.2EudraCT number2009-016457-18
    A.3Full title of the trial
    A Multicentre, Single-Arm, Open-Label Study Of The Repeated Administration Of QUTENZA For The Treatment Of Peripheral Neuropathic Pain
    A.3.2Name or abbreviated title of the trial where available
    STRIDE
    A.4.1Sponsor's protocol code numberE05-CL-3001
    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 SponsorAstellas Pharma Europe Ltd
    B.1.3.4CountryNetherlands
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Yes
    D.2.1.1.1Trade name QUTENZA (TM)
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameQutenza
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Medicated plaster
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCAPSAICIN
    D.3.9.1CAS number 404864
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameCAPSAICIN
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number179
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Peripheral Neuropathic Pain in Postherpetic Neuralgia (PHN), Painful HIV-Associated Neuropathy (HIV-AN), Peripheral Neuropathic Injury (PNI), Idiopathic Small Nerve Neuropathy (ISNN) or other Peripheral Neuropathic Pain (PNP).
    E.1.1.1Medical condition in easily understood language
    Pain felt in the limbs caused by a reaction of the nervous system
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10054095
    E.1.2Term Neuropathic pain
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety of repeated treatments of QUTENZA in subjects with peripheral neuropathic pain.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of repeated treatments of QUTENZA in subjects with peripheral neuropathic pain.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Common Inclusion Criteria:
    1. Male or female between 18 and 90 years of age, inclusive
    2. Be in good health as determined by the investigator
    3. Average pain score >=4 during screening period (using the average reported pain from the Brief Pain Inventory [BPI])
    4. Intact, unbroken skin over the painful area(s) to be treated
    5. All females of child bearing potential must be willing to use effective methods of birth control during the study and for 30 days following study termination
    6. Be willing and able to comply with protocol requirements for the duration of study participation
    7. Subject has given written informed consent

    Population-specific Inclusion Criteria:
    All subjects must meet one (and only one) of the Population-Specific Inclusion Criteria for PHN, HIV-AN, PNI or ISNN or have adequately characterized peripheral neuropathic pain based on clinical history and examination:

    Postherpetic Neuralgia (PHN)
    Prior diagnosis of PHN with pain persisting at least 3 months since shingles vesicle crusting, documented by the primary treating physician or investigator
    Or
    Painful HIV-Associated Neuropathy (HIV-AN)
    Confirmation of HIV-AN existing for a minimum of 3 months, as assessed using the Brief Peripheral Neuropathy Screen (BPNS)
    Or
    Peripheral Neuropathic Injury (PNI)
    Diagnosis of Post-traumatic Peripheral Neuropathic Pain syndrome, including post-surgical neuropathic pain, neuropathic pain due to peripheral nerve injury, confirmed by a qualified pain specialist and persisting for a minimum of 3 months following the traumatic event
    Or
    Idiopathic Small Nerve Neuropathy (ISNN)
    Diagnosis of ISNN based on clinical and electrodiagnostic criteria:
    Neuropathy exclusively or predominantly affecting A-δ (small myelinated) and nociceptive C (unmyelinated) nerve fibres
    Loss of pinprick and temperature sensation in feet
    Or
    Other Peripheral Neuropathic Pain (PNP)
    Adequately characterized peripheral neuropathic pain based on clinical history and examination existing at the time of screening.

    E.4Principal exclusion criteria
    1. Any prior receipt of QUTENZA open label or blinded study patches
    2. Use of oral or transdermal opioids exceeding a total daily dose of morphine of 80 mg/day, or equivalent; or any parenteral opioids, regardless of dose, within 7 days preceding the first patch application visit.
    3. Lack of an effective pain medication strategy for the subject, such as unwillingness to use opioid analgesics during study treatment, or high tolerance to opioids precluding the ability to relieve treatment-associated discomfort with oxicodone or other analgesic, as judged by the investigator
    4. Active substance abuse or history of chronic substance abuse within 1 year prior to enrolment or prior chronic substance abuse (including alcoholism) judged likely to re-occur during the study period by the investigator
    5. Use of any topical pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anaesthetics, steroids or capsaicin products on the painful areas within 7 days preceding the first patch application visit
    6. Current use of any investigational agent (excluding antiretrovirals in Phase 3 evaluation to treat HIV infection)
    7. Unstable or poorly controlled hypertension or a recent history of a cardiovascular event which, in the opinion of the investigator, would put the patient at risk of adverse cardiovascular reactions related to the patch application procedure
    8. Evidence of another contributing cause for peripheral neuropathy, and/or treatment within 90 days prior to screening visit with any drug that may have contributed to the sensory neuropathy
    9. Past or current history of Type I or Type II diabetes mellitus
    10. Current psychotic disorders
    11. Clinically significant abnormal ECG at screening
    12. Hypersensitivity to capsaicin (i.e., chilli peppers or Over-the-counter [OTC] capsaicin products),any QUTENZA excipients, local anaesthetics, oxycodone, hydrocodone, or adhesives
    13. Significant ongoing or untreated abnormalities in cardiac, renal, hepatic, or pulmonary function that may interfere either with the ability to complete the study or the evaluation of adverse events
    14. Significant pain of an aetiology other than painful HIV-AN, PHN, PNI, ISNN or other adequately characterized peripheral neuropathic pain for example, compression-related neuropathies (e.g., spinal stenosis), fibromyalgia or arthritis
    15. Posttraumatic neuropathic pain due to Complex Regional Pain Syndrome (CRPS, Type I)
    16. Active malignancy or history of malignancy during the past 5 years (a history of squamous cell carcinoma or a basal cell carcinoma not involving the area to be treated is allowed)
    17. Evidence of cognitive impairment including dementia that may interfere with subject’s ability to complete study evaluations and recall pain levels in the past 24 hours
    18. Planned elective surgery during the trial
    19. Neuropathic pain areas located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes.
    20. Female subjects of child-bearing potential with a positive serum or urine pregnancy test prior to treatment
    E.5 End points
    E.5.1Primary end point(s)
    Adverse events, serious adverse events and treatment emergent adverse events, including the proportion of subjects who prematurely terminate from the study due to an AE

    Sensory function: change from screening visit of warm, cold sharp and vibration sensations and allodynia, assessed at patch application visits, week 26 (if applicable) and the planned or early termination visit.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at the screening visit, at all patch application visits, at week 26 visit (if applicable), and at the planned or early termination visit.
    E.5.2Secondary end point(s)
    Secondary Safety Variables:
    - Use of concomitant pain medications following each patch application
    - Vital signs, including changes from baseline and before and after patch application
    - The number and percentage of patients with each dermal assessment score at screening visit, study patch application visits (prior to and after patch application) and at planned or early termination visit
    - The proportion of subjects completing at least 90% of the intended patch application duration
    - Neurological assessment from screening visit to planned or early termination visit

    Secondary Efficacy Variables
    - Brief Pain Inventory (BPI) at screening visit, at every patch application visit, weekly between patch application visits and at planned or early termination visit, including changes from baseline and before and after each patch application.
    - Patient Global Impression of Change (PGIC) questionnaire at patch application visits (except the first patch application visit), 4 weeks after each patch application visit, at week 26 (if applicable) and at the planned or early termination visit.
    - Quality of Life (QoL) information at each study visit, and also 4 weeks after each patch application
    - Self-Assessment of Treatment (SAT) questionnaire at week 26 (if applicable) and planned or early termination visit
    - Change in use of concomitant pain medications from screening visit to planned or early termination visit
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety:
    at the screening visit, at all patch application visits, at week 26 visit (if applicable), and at the planned or early termination visit.

    Efficacy:
    at the screening visit, prior to any procedures relating to the painful area(s) at each study application visit, 4 weeks after each patch application visit, at the week 26 visit (if applicable) and at the planned or early termination visit.
    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 No
    E.6.6Pharmacokinetic No
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    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
    The end of trial is defined in the protocol.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    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)
    As QUTENZA is an authorised product in the Community, subjects may be prescribed the product by their physician if it is considered to be of benefit.
    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 Decision2010-07-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-09-26
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