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    Summary
    EudraCT Number:2021-001238-21
    Sponsor's Protocol Code Number:2020-SESGEN
    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:2021-06-11
    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 number2021-001238-21
    A.3Full title of the trial
    Gender biases in pain medicine: from omics to healthcare.
    Sesgos de género en la medicina del dolor: de las ómicas a la atención sanitaria.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Gender differences in pain medicine: from genetics to healthcare.
    Diferencias de género en medicina del dolor: de la genética a la atención sanitaria.
    A.3.2Name or abbreviated title of the trial where available
    SESGEN
    SESGEN
    A.4.1Sponsor's protocol code number2020-SESGEN
    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 SponsorInstitute of Health and Biomedical Research of Alicante
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportInstituto de Salud Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitute of Health and Biomedical Research of Alicante
    B.5.2Functional name of contact pointClinical trial area
    B.5.3 Address:
    B.5.3.1Street AddressAvda Pintor Baeza, 12 HGUA. Centro de Diagnóstico. Planta 5ª
    B.5.3.2Town/ cityAlicante
    B.5.3.3Post code03010
    B.5.3.4CountrySpain
    B.5.4Telephone number34965 913 952
    B.5.6E-mailisabial_eecc@gva.es
    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.2.1.2Country 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 nameMorphine
    D.3.4Pharmaceutical form Compressed lozenge
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMORPHINE SULFATE
    D.3.9.1CAS number 64-31-3
    D.3.9.3Other descriptive nameMORPHINE SULFATE
    D.3.9.4EV Substance CodeSUB14597MIG
    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 Yes
    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 nameFentanyl
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFENTANYL
    D.3.9.1CAS number 437-38-7
    D.3.9.3Other descriptive nameFENTANYL
    D.3.9.4EV Substance CodeSUB07597MIG
    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: 3
    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.2.1.2Country 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 nameTramadol
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRAMADOL HYDROCHLORIDE
    D.3.9.1CAS number 27203-92-5
    D.3.9.3Other descriptive nameTRAMADOL HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB04927MIG
    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
    The medical condition to be evaluated is the analgesic response of people with chronic low back pain who are going to be treated with opioids, guided by omics sciences (pharmacogenetics, epigenetics and metabolomics).
    La condición médica a evaluar es la respuesta analgésica de las personas con dolor crónico causado por lumbalgia que van a ser tratadas con opioides, cuyo tratamiento será guiado por las ciencias ómicas (farmacogenética, epigenética y metabolómica).
    E.1.1.1Medical condition in easily understood language
    The medical condition to be evaluated is the analgesic response of people with chronic low back pain who are going to be treated with opioids, guided by genetics information.
    La condición médica a evaluar es la respuesta analgésica de las personas con dolor crónico causado por lumbalgia que van a recibir tratamiento con opioides, guiado según su información genética.
    E.1.1.2Therapeutic area Health Care [N] - Health Care Quality, Access, and Evaluation [N05]
    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
    The main objective is to understand through pharmacogenetic markers and epigenetic changes, the different response to opioid analgesics appreciated in women.
    El objetivo principal es comprender a través de marcadores farmacogenéticos y cambios epigenéticos, la diferente respuesta a los analgésicos opioides apreciada en las mujeres.
    E.2.2Secondary objectives of the trial
    1. Identify the metabolic profile according to the activity of the CYP2D6 enzyme.
    2. Analyze the epigenetic expression of the OPRM1 and COMT genes, based on sex, their genetic variants and analgesic response.
    3. Analyze pharmacokinetics (AUC, Cmax) based on sex and analgesic response, determining the plasma concentrations of analgesics (tramadol, morphine or fentanyl) and their active metabolites.
    4. Analyze the influence of the hormonal profile and the moment of the menstrual cycle, and its relationship with the analgesic response.
    5. Study the influence of gender roles (sociocultural) on the analgesic response.
    1. Identificar el perfil metabólico según la actividad de la enzima CYP2D6.
    2. Analizar la expresión epigenética de los genes OPRM1 y COMT, en función del sexo, sus variantes genéticas y respuesta analgésica.
    3. Analizar la farmacocinética (AUC, Cmax) en función del sexo y la respuesta analgésica, determinando las concentraciones plasmáticas de analgésicos (tramadol, morfina o fentanilo) y sus metabolitos activos.
    4. Analizar la influencia del perfil hormonal y el momento del ciclo menstrual, y su relación con la respuesta analgésica.
    5. Estudiar la influencia de los roles de género (socioculturales) en la respuesta analgésica.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1- Patients over 18 years of age.
    2- Low back pain for more than 6 months, as a model of non-cancer chronic pain.
    3- Patients naïve to opioids and who require analgesic treatment with opioids (tramadol, morphine or fentanyl).
    1- Pacientes mayores de 18 años.
    2- Lumbalgia durante más de 6 meses, como modelo de dolor crónico no oncológico.
    3- Pacientes naïve a opioides y que requieran tratamiento analgésico con opioides (tramadol, morfina o fentanilo).
    E.4Principal exclusion criteria
    1- Subjects with some type of cancer or metastatic pain.
    2- Subjects with use of drugs or products metabolized by CYP2D6.
    3- Presence or history of allergy to analgesics or pain treatment aids.
    4- Pregnant women
    5- Presence or history of abuse of prohibited substances.
    6- Patients with a history of psychiatric disability that the researcher considers clinically significant, and that prevents the patient from granting their consent or interferes with the proper development of the study.
    7- Participants in any other trial during the study period or 30 previous days.
    8- Patients who deny their informed consent in writing.
    1- Sujetos con algún tipo de cáncer o dolor metastásico.
    2- Sujetos con uso de fármacos o productos metabolizados por CYP2D6.
    3- Presencia o antecedentes de alergia a analgésicos o auxiliares para el tratamiento del dolor.
    4- Mujeres embarazadas
    5- Presencia o historial de abuso de sustancias prohibidas.
    6- Pacientes con antecedente de discapacidad psiquiátrica que el investigador considere clínicamente significativo, y que impida al paciente otorgar su consentimiento o interfiera con el correcto desarrollo del estudio.
    7- Participantes en cualquier otro ensayo durante el período de estudio o 30 días previos.
    8- Pacientes que denieguen su consentimiento informado por escrito.
    E.5 End points
    E.5.1Primary end point(s)
    In the first part of the project, we will study the relationship between the analgesic response of patients with chronic pain, and their genetic / epigenetic information for the COMT, OPRM1 and CYP2D6 genes.
    It is expected to find a lower analgesic response, in women, extreme CYP2D6 phenotypes (slow or ultrafast), which present a higher % of methylation in the OPRM1 (position +117) and COMT genes.
    En la primera parte del proyecto estudiaremos la relación entre la respuesta analgésica de pacientes con dolor crónico y su información genética / epigenética para los genes COMT, OPRM1 y CYP2D6.
    Se espera encontrar una menor respuesta analgésica en mujeres, fenotipos extremos de CYP2D6 (lento o ultrarrápido), que presentan un mayor % de metilación en los genes OPRM1 (posición +117) y COMT.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year
    1 año
    E.5.2Secondary end point(s)
    In the second part of the project, patients will be grouped in a group guided by sex and omics and a control group. The group guided by sex and omics will be treated taking into account their genetic/epigenetic information. The control group will follow the usual treatment.
    We expect to get better analgesic response in the group guided by sex and genetic/epigenetic information.
    En la segunda parte del proyecto, los pacientes se agruparán en un grupo guiado por sexo y ómicas y un grupo de control. El grupo guiado por el sexo y las ómicas será tratado teniendo en cuenta su información genética / epigenética. El grupo de control seguirá el tratamiento habitual.
    Esperamos obtener una mejor respuesta analgésica en el grupo guiado por el sexo y la información genética / epigenética.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the study, 4 years.
    Al final del estudio, 4 años.
    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 Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Tipo de tratamiento “guiado” por sexo y ómicas (caso) vs. otro sin información (control)
    Type of treatment “guided” by sex and omics (case) vs. another without information(control)
    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 concerned3
    E.8.5The trial involves multiple Member States No
    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 No
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 250
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state500
    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)
    After the trial the patients will continue with their usual treatment
    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 Decision2021-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-16
    P. End of Trial
    P.End of Trial StatusOngoing
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