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    Summary
    EudraCT Number:2021-001409-64
    Sponsor's Protocol Code Number:AV001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-07-20
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2021-001409-64
    A.3Full title of the trial
    An interventional, Phase III, double-blind, randomized, controlled, parallel-group, multi-site, clinical trial evaluating the efficacy and safety of Qutenza® in subjects with post-surgical neuropathic pain
    Ensayo clínico de intervención en fase III, multicéntrico, aleatorizado, con doble enmascaramiento, controlado y con grupos paralelos para confirmar la eficacia y la seguridad de Qutenza® en pacientes con dolor neuropático posquirúrgico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multi site clinical trial to evaluate the efficacy and safety of Qutenza® in subjects with post-surgical neuropathic pain
    Un ensayo clínico en varios centros para evaluar la eficacia y seguridad de Qutenza® en pacientes con dolor neuropático posquirúrgico
    A.4.1Sponsor's protocol code numberAV001
    A.5.4Other Identifiers
    Name:IND numberNumber:063354
    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 SponsorAveritas Pharma, 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 supportAveritas Pharma, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAveritas Pharma, Inc.
    B.5.2Functional name of contact pointHead of Medical Affairs
    B.5.3 Address:
    B.5.3.1Street Address360 Mount Kemble Avenue
    B.5.3.2Town/ cityMorristown, NJ
    B.5.3.3Post code07960
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 561-303-7721
    B.5.6E-maillizandra.marcondes@grunenthal.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 Yes
    D.2.1.1.1Trade name Qutenza
    D.2.1.1.2Name of the Marketing Authorisation holderGrünenthal GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameCapsaicin
    D.3.4Pharmaceutical form Cutaneous patch
    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 404-86-4
    D.3.9.3Other descriptive nameCAPSAICIN
    D.3.9.4EV Substance CodeSUB13229MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 No
    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 nameCapsaicin
    D.3.4Pharmaceutical form Cutaneous patch
    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 404-86-4
    D.3.9.3Other descriptive nameCAPSAICIN
    D.3.9.4EV Substance CodeSUB13229MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number0.9
    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
    Post-surgical neuropathic pain (PSNP)
    Dolor neuropático posquirúrgico (DNPQ)
    E.1.1.1Medical condition in easily understood language
    Post-surgical neuropathic pain (PSNP)
    Dolor neuropático posquirúrgico (DNPQ)
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10054095
    E.1.2Term Neuropathic pain
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate superiority of Qutenza over low-dose capsaicin control in change from baseline to Week 12 in the 24-hr average pain intensity in subjects with PSNP.
    Demostrar que Qutenza produce mejores resultados en la intensidad promedio del dolor durante 24 horas con respecto al control con dosis baja de capsaicina desde el momento inicial hasta la semana 12 en pacientes con dolor neuropático posquirúrgico.
    E.2.2Secondary objectives of the trial
    Core Phase:
    • To demonstrate superiority of Qutenza over low-dose capsaicin control in change from baseline to Week 12 in treatment area size in subjects with PSNP.
    • To assess the safety and tolerability of Qutenza in subjects with PSNP.

    Extension Phase:
    • To confirm the long-term efficacy of Qutenza in subjects with PSNP.
    • To assess the long-term safety and tolerability of Qutenza in subjects with PSNP.
    Fase Cenral:
    -Demostrar que Qutenza produce mejores resultados en el tamaño de la zona de tratamiento con respecto al control con dosis baja de capsaicina desde el momento inicial hasta la semana 12 en pacientes con dolor neuropático posquirúrgico.
    -Evaluar la seguridad y la tolerabilidad de Qutenza en pacientes con dolor neuropático posquirúrgico.
    Fase de ampliación:
    -Confirmar la eficacia a largo plazo de Qutenza en pacientes con dolor neuropático posquirúrgico.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General
    1. The subject has given written informed consent to participate.
    2. Female or male subjects aged 18 years or older.
    3. For women of childbearing potential: negative pregnancy tests at Screening Visit (Visit 1), the Randomization Visit (Visit 2), and prior to each reapplication of the IMP, and must have agreed to practice medically acceptable methods of birth control.

    Confirmation of diagnosis of chronic moderate to severe PSNP (see also Protocol Table 1)
    4. Documented diagnosis of PSNP by the following criteria:
    a. A history of post-surgical pain with a duration of at least 6 months to maximally 36 months that is plausibly related to the surgical intervention as documented on a body map.
    b. DN4i of at least 3 out of 7 points at Visit 1.
    c. The pain must extend beyond the scar area to neuroanatomically adjacent skin areas and be related to the site of the surgery.
    5. Documented diagnosis of probable or definite PSNP according to the following criteria:
    a. The pain must be associated with sensory signs in the same neuroanatomically plausible distribution. The area of sensory changes may extend beyond, be within, or overlap with the area of pain (criterion for probable neuropathic pain), or
    b. In addition to 5a : Direct surgical evidence (e.g., surgeon´s clear verification of an intraoperative nerve lesion) (criterion for definite neuropathic pain).
    6. The subject has moderate to severe pain with a baseline value for 24-hr average pain intensity of at least 4 points on the NPRS. The baseline value is calculated as the average of the 24-hr average pain intensity ratings of the Baseline Phase (Day -7 to Day -1). At least 5 (out of 7) pain ratings should be available during the Baseline Phase. If less than 5 pain ratings are available, the subject may be rescheduled for Visit 2 (1 time only) after having received appropriate re-training in the use of the e-diary to ensure compliance.

    Suitability for treatment with IMP
    7. The size of the affected painful intact skin area is not larger than the size of 4 standard Qutenza topical systems (1120 cm2).
    8. The skin in the area where the IMP will be applied, and that may also contain the scar tissue, is intact, dry, and non-irritated (i.e., there are no signs and symptoms of skin disease, skin irritation, inflammation or injury, such as active herpes zoster lesions, atopic dermatitis, ulceration, wounds).
    Eligibility with regard to protocol adherence, to allowed pre-treatments and concomitant treatments
    9. The subject is willing to adhere to the restricted use of concomitant treatments (see concomitant treatments in Section 1.4.2).
    10. The subject experiencing pain is:
    a. currently not receiving treatment for PSNP or
    b. receives a stable systemic treatment for PSNP that started more than 30 days prior to the Randomization Visit (Visit 2).
    Generales
    1. El paciente ha proporcionado consentimiento informado por escrito para participar.
    2. Hombres y mujeres de 18 años de edad o mayores.
    3. Mujeres en edad fértil: resultados negativos en las pruebas de embarazo durante la visita de selección (visita 1), la visita de aleatorización (visita 2) y antes de que se repita la aplicación del PEI; además, deben haber aceptado utilizar métodos anticonceptivos aceptables desde el punto de vista médico.
    Confirmación del diagnóstico de dolor neuropático posquirúrgico crónico de moderado a grave (véase la tabla 1 «Lista de algunos ejemplos de tipos de intervenciones quirúrgicas que pueden provocar dolor neuropático posquirúrgico»)
    4. Diagnóstico comprobado de dolor neuropático posquirúrgico según los siguientes criterios:
    a. Antecedentes de dolor posquirúrgico con una duración de al menos 6 meses hasta 36 meses, que se pueda asociar de manera factible con la intervención quirúrgica conforme a lo registrado en un mapa corporal.
    b. DN4i de al menos 3 puntos de 7 en la visita 1.
    c. El dolor debe ampliarse más allá de la zona cicatricial a otras zonas neuroanatómicamente adyacentes y guardar relación con el lugar de la intervención quirúrgica.
    5. Diagnóstico comprobado de dolor neuropático posquirúrgico probable o evidente de acuerdo con los criterios siguientes (Finnerup et al. 2016):
    a. El dolor se debe asociar con signos sensoriales en la misma distribución neuroanatómica posible. La zona de los cambios sensoriales se puede ampliar más allá de la zona del dolor, estar contenida en ella o superponerse (criterio del dolor neuropático probable) o
    b. Además de 5a: datos probatorios quirúrgicos directos (p. ej., verificación inequívoca de una lesión nerviosa intraoperatoria por parte del cirujano) (criterio del dolor neuropático evidente).
    6. El paciente sufre un dolor de moderado a grave con un valor inicial de la intensidad promedio del dolor durante 24 horas de al menos 4 puntos en la NPRS. El valor inicial se calcula como el promedio de las puntuaciones de la intensidad promedio del dolor durante 24 horas en la fase inicial (desde el día -7 hasta el día -1). Se debe disponer de al menos 5 puntuaciones del dolor (de las 7 totales) durante la fase inicial. Si se dispone de menos de 5 puntuaciones del dolor, se tendrá que volver a programar la visita 2 (solo 1 vez) para el paciente, después de haber repetido la formación sobre el uso del diario electrónico para garantizar que se usa de manera correcta.Idoneidad para el tratamiento con el PEI
    7. El tamaño de la zona afectada de piel intacta con dolor no debe ser mayor que el de 4 parches tópicos estándar de Qutenza (1120 cm2).
    8. La piel de la zona donde se aplicará el PEI, que también puede tener tejido cicatricial, debe estar intacta, seca y sin irritación (o sea, no debe haber signos ni síntomas de dermopatía, irritación de la piel, inflamación ni lesiones, como lesiones de herpes zóster activa, dermatitis atópica, úlceras ni heridas).
    Idoneidad con respecto a la adherencia al protocolo, a los tratamientos previos permitidos y a los tratamientos concomitantes.
    9. El paciente debe estar dispuesto a seguir un uso restringido de los tratamientos concomitantes (véanse los tratamientos concomitantes en el apartado 1.4.2).
    10. El paciente que sufre dolor:
    a. no debe estar recibiendo un tratamiento para el dolor neuropático posquirúrgico o
    b. está recibiendo un tratamiento sistémico estable para el dolor neuropático posquirúrgico que se inició antes de los 30 días previos a la visita de aleatorización (visita 2).
    E.4Principal exclusion criteria
    General or previous treatments
    1. The subject received Qutenza before the Randomization Visit (Visit 2) or received a medical device in another clinical trial within 7 days before the Randomization Visit (Visit 2), or
    a. Any former use of topical capsaicin in the area of the PSNP before Visit 2, except for the use of a low-dose (<1%) capsaicin product – but not within 7 days before Visit 2.
    b. The subject participated previously in this clinical trial or participated in another clinical trial for the treatment of PSNP completing less than 3 months ago.
    2. A score of 0 out of 5 in all 3 categories of the neurological/sensory examinations, i.e., for warm sensation, pinprick and cold sensation at the Screening Visit (Visit 1).

    Confounding factors
    3. The subject reported a 24-hr average pain intensity score of 10 on the NPRS for at least 4 days during the Baseline Phase.
    4. Any painful procedure planned during the course of the trial that may, in the opinion of the investigator, affect the efficacy or safety assessments.
    5. Subjects with PSNP related to a surgery/condition with a high potential for confounding symptoms, e.g., the pain is at least partially due to pain in deeper structures such as muscles or bones (including referred pain from deeper structures) as listed in examples in
    Protocol Table 2.
    6. Other painful conditions in the body area that is affected by PSNP and may affect efficacy or safety assessments including infectious, non-infectious, inflammatory or neuropathic conditions which could also be complications related to the previous surgical procedure.

    Contraindications to IMP
    7. Neuropathic pain areas located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes.
    8. Hypersensitivity to capsaicin (i.e., chili peppers or over-the-counter [OTC] capsaicin products), or to any excipients of the IMP or to excipients of the cleansing gel in use and their components, or to topical anesthetics in use and their components.

    Medical history/concurrent condition(s)/other factors
    9. Pending litigation due to chronic pain or disability.
    10. The subject has a history of alcohol or drug abuse or is actively abusing drugs (including alcohol, medication) during the 1 year prior to the Screening Visit (Visit 1) as judged by the investigator.
    11. Evidence or history of severe psychiatric illness/disorder during the 3 years prior to the Screening Visit (Visit 1) that, in the investigator’s opinion, may affect efficacy or safety assessments or may compromise the subject’s safety during trial participation, e.g., major depression, major anxiety disorder, psychosis, severe personality disorders.
    12. Evidence of cognitive impairment including dementia that may interfere with the subject’s ability to complete pain assessments requiring recall of the average pain level in the past 24 hrs.
    13. Surgical intervention in the last 3 months preceding the Screening Visit (Visit 1) if it is affecting the efficacy or safety assessments, or any scheduled or planned surgery during the trial, with the exception of the Extension Phase if the planned surgery is not expected to affect the efficacy or safety assessments.
    14. Patients with current clinically significant disease(s) or condition(s) (including clinically significant cardiovascular disease and/or significant pain in other areas) that may affect efficacy or safety assessments, or any other reason which, in the investigator’s opinion, may preclude the subject’s participation in the full duration of the trial.
    15. Unstable or poorly controlled blood pressure which, in the opinion of the investigator, would put the subject at risk of severe adverse blood pressure increases upon IMP application.
    16. Known or suspected of not being able to comply with the requirements of the trial protocol or the instructions of the trial site staff.
    17. Not able to communicate meaningfully with the trial site staff.
    18. The subject is an employee of the investigator or trial site, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial site, or is a family member of the employees or the investigator.
    Tratamientos generales o anteriores
    1.Pacientes que han recibido Qutenza con anterioridad a la visita de aleatorización (visita 2) u otro dispositivo médico en otro ensayo clínico durante los 7 días previos a la visita de aleatorización (vista 2), o
    a.Pacientes que han usado capsaicina por vía tópica en la zona del dolor neuropático posquirúrgico antes de la visita 2, excepto productos con dosis bajas de capsaicina (menos del 1 %), pero no en los 7 días previos a la visita 2. b.Pacientes que han participado con anterioridad en este ensayo clínico o en otros para el tratamiento del dolor neuropático posquirúrgico que han finalizado hace menos de 3 meses.
    2.Una puntuación de 0 de un total posible de 5 en las 3 categorías de las exploraciones neurológicas o sensoriales, o sea, la de la sensación de calor, la del pinchazo y la de la sensación de frío, en la visita de selección (visita 1).
    Factores de confusión
    3.El paciente comunicó una puntuación de 10 en la NPRS de la intensidad promedio del dolor durante 24 horas durante al menos 4 días en la fase inicial.
    4.Cualquier procedimiento doloroso programado durante el transcurso del ensayo que pueda, en opinión del investigador, afectar las evaluaciones de la eficacia o la seguridad.
    5.Pacientes con dolor neuropático posquirúrgico asociado con una intervención quirúrgica o enfermedad con una alta posibilidad de presentar factores de confusión, o sea, que el dolor se deba en parte al dolor en estructuras más profundas, como los músculos o los huesos (incluido el dolor referido procedente de estructuras más profundas) según se muestra en los ejemplos de la tabla 2.
    6.Otras afecciones dolorosas en la zona del organismo afectada por el dolor neuropático posquirúrgico y que pueden influir en las evaluaciones de eficacia o de seguridad, como afecciones infecciosas, no infeccionas, inflamatorias o neuropáticas que también podrían ser complicaciones asociadas con el procedimiento quirúrgico anterior.Contraindicaciones del PEI
    7.Zonas con dolor neuropático situadas solo en la cara, por encima de la línea de nacimiento del cabello en el cuero cabelludo o cerca de membranas mucosas.
    8.Hipersensibilidad a la capsaicina (o sea, a las guindillas o a los productos con capsaicina de venta sin receta médica), a cualquiera de los excipientes del PEI, a los excipientes del gel limpiador que se usa y sus componentes o a la anestesia tópica que se usa y sus componentes.
    Antecedentes médicos, afecciones simultáneas y otros factores
    9.Pleito pendiente por discapacidad o dolor crónico.
    10.El paciente tiene antecedentes de alcoholismo o adicción a las drogas, o sigue sufriendo adicción a las drogas (incluido el alcohol y los medicamentos) durante el 1 año anterior a la visita de selección (visita 1), según el criterio del investigador.
    11.Datos probatorios o antecedentes de enfermedades o trastornos psiquiátricos graves durante los 3 años anteriores a la visita de selección (visita 1) que, según la opinión del investigador, podrían influir en las evaluaciones de la eficacia o la seguridad, o podrían poner en peligro la seguridad del paciente durante su participación en el ensayo, p. ej., depresión mayor, trastorno importante de ansiedad, psicosis y trastornos graves de la personalidad.
    12.Datos probatorios de deterioro cognitivo, como la demencia, que pueda interferir con la capacidad del paciente para completar evaluaciones del dolor que requieran recordar la intensidad promedio del dolor durante las 24 horas anteriores.
    13.Una intervención quirúrgica durante los 3 meses anteriores a la visita de selección (visita 1) si puede influir en las evaluaciones de la eficacia o la seguridad, o cualquier intervención quirúrgica programada o prevista durante el ensayo, a excepción de la fase de ampliación si no se espera que la intervención quirúrgica prevista afecte a las evaluaciones de la eficacia o la seguridad.
    14.Pacientes que sufran afecciones o enfermedades de importancia clínica (incluidas las enfermedades cardiovasculares con importancia clínica o dolores importantes en otras zonas) que puedan influir en las evaluaciones de la eficacia o la seguridad, o cualquier otro motivo que, en opinión del investigador, pueda impedir la participación del paciente en el ensayo completo.
    15.Presión arterial inestable o mal controlada que, en opinión del investigador, pueda suponer un riesgo adverso de hipertensión arterial grave para el paciente tras la aplicación del PEI.
    16.Signos o la sospecha de que el paciente no podrá cumplir los requisitos del protocolo del ensayo o seguir las instrucciones del personal del centro del ensayo.
    17.No poderse comunicar de manera coherente con el personal del centro del ensayo.
    18.El paciente es empleado del centro del investigador o del ensayo, participa de manera directa en el ensayo propuesto o en otros ensayos bajo la dirección de ese investigador o del centro del ensayo, o es un pariente de los empleados o del investigador.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to the average score of the entire period between Week 2 and Week 12 in the 24-hr average pain intensity.
    Cambio de la intensidad promedio del dolor durante 24 horas desde el momento inicial hasta la puntuación promedio de todo el periodo entre la semana 2 y la semana 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    from the Baseline Phase (Day -7 to Day -1) to Visit 6 (Week 12/Day 84).
    desde la fase inicial (desde el día -7 hasta el día -1) hasta la visita 6
    (semana 12/día 84).
    E.5.2Secondary end point(s)
    Core Phase:
    1. Change from baseline to Week 12 in the treatment area size.
    2. Incidence of treatment-emergent adverse events (TEAEs). Incidence of TEAEs leading to discontinuation in the Core Phase.

    Extension Phase:
    1. Change from baseline to the weekly average score of Week 42 in the 24-hr average pain intensity.
    2. Change from baseline to Week 42 in the treatment area size.
    3. Change from baseline to the average score of the entire period between Week 2 and Week 42 in the 24-hr average pain intensity.
    4. Incidence of TEAEs. Incidence of TEAEs leading to discontinuation in the Extension Phase.
    Fase Central:
    1.Cambio en el tamaño de la zona de tratamiento desde el momento inicial hasta la semana 12.
    2.Incidencia de acontecimientos adversos surgidos durante el tratamiento (AAST).Incidencia de AAST que producen la retirada en la fase central.

    Fase de ampliación:
    1.Cambio en la intensidad promedio del dolor durante 24 horas desde el momento inicial hasta la puntuación promedio semanal en la semana 42.
    2.Cambio en el tamaño de la zona de tratamiento desde el momento inicial hasta la semana 42.
    3.Cambio en la intensidad promedio del dolor durante 24 horas desde el momento inicial hasta la puntuación promedio de todo el periodo entre la semana 2 y la semana 42.
    4.Incidencia de AAST. Incidencia de AAST que producen la retirada en la fase de ampliación.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Core Phase
    1. At Visit 2 (Day 1) before IMP application and at Visit 6 before IMP application (Week 12/Day 84)
    2. Documentation of TEAEs from the start of treatment at Visit 2(Day 1) up to the time of the last scheduled contact in the Core Phase of the Treatment Period

    Extension Phase
    1.From the Baseline Phase(Day -7 to Day -1) to Final Visit(Week 42/Day 294)
    2.At Visit 2 (Day 1) before IMP application and at Visit 6 before IMP application (Week 12/Day 84)
    3.From the Baseline Phase (Day -7 to Day -1) to the Final Visit(Week 42/Day 294)
    4.Documentation of TEAEs from start of treatment at Visit 2(Day 1) up to the time of the last scheduled contact in the Extension Phase of the Treatment Period
    F.Central:1.En la V2(D1)antes de la aplicación del producto en investigación (PEI) y en la V6 antes de la aplicación del PEI(sem12/día84).2.Documentar los AAST desde el inicio del tratamiento en la V2(D1)hasta el momento en que se produzca el último contacto programado en la fase central del periodo de tratamiento
    F.Ampliación:1.Desde la fase inicial (D-7 hasta el D-1) hasta la V.final(sem42/D294).2.En la V2 (D1) antes de la aplicación del producto en investigación (PEI) y en la V6 antes de la aplicación del PEI (sem12/D84).3.Desde la fase inicial (D-7 hasta el D-1) hasta la V.final (sem42/D294).
    4.Documentar los AAST desde el inicio del tratamiento en la V2 (D1) hasta el momento en que se produzca el último contacto programado en la fase de ampliación del periodo de tratamiento.
    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 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) Yes
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 Yes
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    France
    Netherlands
    Poland
    Spain
    United Kingdom
    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 trial-related end of the trial is defined as the date of last subject out.
    The subject-related end of trial is defined as date of last contact with the subject according to the protocol.
    El fin de estudio se define como la fecha de la ultima salida del paciente.
    El final del estudio relacionado con el sujeto se define como la fecha del último contacto con el sujeto de acuerdo con el protocolo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days5
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days5
    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: 340
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 170
    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 state55
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 226
    F.4.2.2In the whole clinical trial 510
    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)
    None
    Ninguno
    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 Decision2021-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-10
    P. End of Trial
    P.End of Trial StatusOngoing
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