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    Summary
    EudraCT Number:2011-003302-24
    Sponsor's Protocol Code Number:ESTEVE-SIGM-201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-09-27
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2011-003302-24
    A.3Full title of the trial
    An exploratory, randomized, double blind, placebo controlled, parallel groups Phase II clinical trial to evaluate the efficacy and safety of E-52862 (400 mg) by oral route, as part of an analgesic therapy balanced with morphine, followed by an open label extension, in the treatment of post-operative pain due to abdominal hysterectomy.
    Ensayo clínico fase II, aleatorizado, doble-ciego, controlado con placebo y de grupos paralelos, para evaluar la eficacia y seguridad de E-52862 (400 mg) por vía oral como parte de una terapia de analgesia balanceada con morfina, seguido de un estudio de extensión abierto, en el tratamiento del dolor postoperatorio por histerectomía abdominal.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate the efficacy and safety of E-52862 (400 mg) by oral route in the treatment of post-operative pain due to abdominal hysterectomy.
    Ensayo clínico para evaluar la eficacia y seguridad de E-52862 (400 mg) por vía oral en el tratamiento del dolor postoperatorio por histerectomía abdominal.
    A.4.1Sponsor's protocol code numberESTEVE-SIGM-201
    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 SponsorLaboratorios Dr. Esteve S.A. (ESTEVE)
    B.1.3.4CountrySpain
    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 supportLaboratorios Dr. Esteve S.A. (ESTEVE)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTrial Form Support
    B.5.2Functional name of contact pointSusana Carner
    B.5.3 Address:
    B.5.3.1Street AddressConsell de Cent, 334-336
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08009
    B.5.3.4CountrySpain
    B.5.4Telephone number+3493185 02 00
    B.5.5Fax number+3493185 02 57
    B.5.6E-mailsusana.carner@tfscro.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 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 nameE-52862
    D.3.4Pharmaceutical form Capsule
    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 INN-
    D.3.9.1CAS number 878141-96-9
    D.3.9.2Current sponsor codeE-52862
    D.3.9.3Other descriptive nameE-52862.HCl
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    post-operative pain following abdominal hysterectomy
    Dolor post operatorio tras histerectomía abdominal
    E.1.1.1Medical condition in easily understood language
    post-operative pain following total abdominal hysterectomy
    Dolor post operatorio tras histerectomía abdominal
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    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 primary objective of this study is to assess the analgesic effect of E-52862 compared to placebo on pain following hysterectomy, measured through the morphine consumption administered by Patient Controlled Analgesia (PCA) during the first 24 post-operative hours, pain at rest and movement-evoked pain.
    El objetivo principal de este estudio es evaluar el efecto analgésico de E-52862 comparado con placebo en el dolor posthisterectomía medido en función del consumo de morfina administrado mediante analgesia controlada por el paciente (ACP) durante las primeras 24 horas de postoperatorio, dolor en reposo y dolor provocado por el movimiento.
    E.2.2Secondary objectives of the trial
    To describe the profile of adverse effects of E-52862 in patients undergoing abdominal histerectomy when administered together with and anesthetic regimen and opioids.
    To ensure E-52862 plasma exposure associated with a pharmacodynamic response after administration of repeated oral doses for 3 days in patients undergoing abdominal histerectomy.
    Open label extension sub-study:
    ?To evaluate the incidence of neuropathic pain at 0, 3 and 6 months
    ?To evaluate the quality of life (QoL) at 0, 3 and 6 months
    Describir el perfil de acontecimientos adversos de E-52862 en pacientes sometidas a histerectomía abdominal cuando se administra junto a una pauta posológica de anestesia y opioides.
    Evaluar la exposición plasmática a E-52862 en relación con la respuesta farmacodinámica después de la administración oral repetida durante 3 días a pacientes sometidas a una histerectomía abdominal.
    Subestudio de extensión en abierto:
    ? Evaluar la incidencia e intensidad del dolor neuropático a los 0, 3 y 6 meses
    ? Evaluar la calidad de vida (CdV) a los 0, 3 y 6 meses
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1)Female patients aged between 18 and 80 years
    2)Patients scheduled for an elective non-malignant partial or total abdominal hysterectomy under general anaesthesia (patients with cervix or endometrial carcinoma stage 1 can be also included)
    3)Patients who provide a signed informed consent prior to study entry
    4)Patients with ASA physical status I to III
    5)Patients with preoperative tests previous to the start of treatment
    1)Mujeres de 18 a 80 años de edad
    2)Pacientes programadas para una histerectomía abdominal parcial o total programada por una causa no maligna con anestesia general (también se pueden incluir pacientes con carcinoma de cuello uterino o endometrio en estadio 1)
    3)Pacientes que otorguen su consentimiento informado firmado antes de su entrada en el estudio
    4)Pacientes con un estado físico clase I-III según la ASA
    5)Pacientes con pruebas preoperatorias realizadas antes del inicio del tratamiento
    E.4Principal exclusion criteria
    1)Patients with other pain that may interfere the assessments of the study
    2)Hypersensitivity or allergy to the investigational medicinal product (IMP), to chemically related products or to placebo.
    3)History of alcohol or substance abuse
    4)Uncontrolled chronic disease or a concurrent clinical illness or medical condition that would contraindicate the study participation or confound the interpretation of the results upon the investigator?s opinion
    5)Female with a Body Mass Index (BMI) >35 kg/m2
    6)Patients that will undergo an epidural anaesthesia and nerve block
    7)Patients that have used an investigational drug within 30 days prior to administration of the study medication.
    8)Patients with chronic opioids use or that have been exposed to them during the last month under a continuous regimen
    9)Patients who are unable to cooperate / understand the procedure of the patient-controlled analgesia (PCA) system
    10)Patients taking prohibited medications
    11)Patients with the following laboratory values abnormalities:
    a)ALT, AST and GGT > 2x ULN
    b)Neutrophils < 1500/mm3
    c)Lymphocytes < 1000/ mm3
    d)Haemoglobin < 10 g/dL
    e)Platelets < 100.000 / mm3
    f)Prothrombin time: > 1.25 X ULN
    g)Creatinine: >1.25 x ULN
    h)Any other laboratory abnormality that is judged by the investigator to be clinically relevant
    1)Pacientes con dolor de otro tipo que pueda interferir en las valoraciones del estudio
    2)Hipersensibilidad o alergia al producto en investigación (PEI), a productos relacionados químicamente o a placebo.
    3)Antecedentes de abuso de alcohol o drogas
    4)Enfermedad crónica no controlada o enfermedad clínica concurrente, o afección médica que contraindique la participación en el estudio o que confunda la interpretación de los resultados según la opinión del investigador
    5)Mujeres con un índice de masa corporal (IMC) > 35 kg/m2.
    6)Pacientes que recibirán anestesia epidural y bloqueo nervioso
    7)Pacientes que han recibido algún fármaco en investigación en los 30 días previos a la administración de la medicación del estudio.
    8)Pacientes que reciben opioides crónicamente o que han estado expuestas a ellos durante el último mes con una pauta posológica continua
    9)Pacientes que no pueden colaborar o comprender el funcionamiento del sistema de analgesia controlada por la paciente (ACP)
    10)Pacientes que tomen medicamentos no permitidos
    11)Pacientes con las anomalías analíticas siguientes:
    a)ALT, AST y GGT > 2 x LSN
    b)Neutrófilos < 1500/mm3,
    c)Linfocitos <1000/mm3
    d)Hemoglobina <10 g/dl
    e)Trombocitos <100 000/mm3
    f)Tiempo de protrombina: >1,25 x LSN
    g)Creatinina: > 1,25 x LSN
    h)Cualquier otra anomalía de trascendencia clínica según la opinión del investigador
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be total morphine consumption in mg administered by PCA during the 24 hours post-operative period.
    El criterio de valoración principal será el consumo total de morfina en mg, administrada mediante ACP durante las primeras 24 horas de postoperatorio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    during the 24 hours post-operative period
    durante las primeras 24 horas de postoperatorio.
    E.5.2Secondary end point(s)
    1_Total morphine consumption in mg administered by PCA during the 48 hours post-operative period and during the 24 to 48 hours period
    2_Total morphine consumption in mg administered by PCA plus subcutaneous injection during the 24 and 48 hours post-operative period and during the 24 to 48 hours period.
    3_Pain intensity (at rest and movement-evoked) during the first 24 and 48 hours after the end of surgery
    4_Pain intensity (at rest and movement-evoked) during the first 9 days post surgery
    5_Time to first PCA administration
    6_Consumption and time to first consumption of pain rescue medication
    7_The patients global treatment assessment and patients satisfaction
    8_Pharmacokinetics: Assessment of plasma concentrations at different time points of E-52862 (and morphine and metabolites when deemed necessary). Also, the following pharmacokinetic parameters will be calculated when possible: tmax, Cmax and AUC0-t.
    9_Safety: the number, intensity and causality of adverse events will be compared between treatment groups; adverse events will include clinical abnormalities, vital signs, laboratory abnormalities or ECG abnormalities, as well as any additional finding that may be regarded as an adverse event.
    1_Consumo total de morfina, en mg, administrada mediante ACP durante 48 horas de postoperatorio y entre las 24 horas y las 48 horas de postoperatorio
    2_Consumo total de morfina, en mg, administrada mediante ACP más inyección subcutánea durante las 24 horas y las 48 horas de postoperatorio y durante el período de entre las 24 horas y las 48 horas.
    3_Intensidad del dolor (en reposo y provocado por el movimiento) durante las primeras 24 y 48 horas tras la cirugía
    4_Intensidad del dolor (en reposo y provocado por el movimiento) durante los 9 días posteriores a la cirugía
    5_Tiempo hasta la primera administración de ACP
    6_Consumo y tiempo hasta el primer consumo de medicación de rescate para el dolor
    7_Evaluación global del tratamiento por las pacientes y satisfacción de las pacientes
    8_Farmacocinética: evaluación de las concentraciones plasmáticas en distintos puntos temporales de E-52862 (y de morfina y metabolitos, cuando se considere necesario). Además, cuando sea posible se calcularán los siguientes parámetros farmacocinéticos: tmáx, Cmáx y AUC0-t.
    9_Seguridad: se comparará el número, intensidad y causalidad de los acontecimientos adversos entre los grupos de tratamiento. Los acontecimientos adversos comprenderán las anomalías clínicas, constantes vitales, anomalías analíticas o anomalías en el ECG, así como cualquier otro resultado que pudiera considerarse un acontecimiento adverso.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1_during the 48 hours post-operative period and during the 24 to 48 hours period
    2_during the 24 and 48 hours post-operative period and during the 24 to 48 hours period.
    3_during the first 24 and 48 hours after the end of surgery
    4_during the first 9 days post surgery
    5_Time to first PCA administration
    6_time to first consumption of pain rescue medication
    8_at different time points of E-52862 (and morphine and metabolites when deemed necessary). Also, the following pharmacokinetic parameters will be calculated when possible: tmax, Cmax and AUC0-t.
    1_durante 48 horas de postoperatorio y entre las 24 horas y las 48 horas de postoperatorio
    2_durante las 24 horas y las 48 horas de postoperatorio y durante el período de entre las 24 horas y las 48 horas.
    3_durante las primeras 24 y 48 horas tras la cirugía
    4_durante los 9 días posteriores a la cirugía
    5_Tiempo hasta la primera administración de ACP
    6_tiempo hasta el primer consumo de medicación de rescate para el dolor
    8_en distintos puntos temporales de E-52862 (y de morfina y metabolitos, cuando se considere necesario). Además, cuando sea posible se calcularán los siguientes parámetros farmacocinéticos: tmáx, Cmáx y AUC0-t.
    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 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) 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 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 Yes
    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 concerned15
    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
    Last visit of the last subject
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state120
    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)
    NA
    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 Decision2011-11-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-09-26
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