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    Summary
    EudraCT Number:2015-001548-13
    Sponsor's Protocol Code Number:BRN-C-2015-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-07-10
    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 number2015-001548-13
    A.3Full title of the trial
    RANDOMIZED DOUBLE-BLIND CLINICAL TRIAL TO MEASURE THE EFFICACY OF ACTAEA RACEMOSA (9CH) AND CAULOPHYLLUM THALICTROIDES (9CH) IN THE FIRST STAGE OF LABOR
    ENSAYO CLÍNICO ALEATORIZADO Y DOBLE CIEGO PARA MEDIR LA EFICACIA DE ACTAEA RACEMOSA (9CH) Y CAULOPHYLLUM THALICTROIDES (9CH) EN LA PRIMERA ETAPA DEL PARTO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    RANDOMIZED DOUBLE-BLIND CLINICAL TRIAL TO MEASURE THE EFFICACY OF ACTAEA RACEMOSA (9CH) AND CAULOPHYLLUM THALICTROIDES (9CH) IN THE FIRST STAGE OF LABOR
    ENSAYO CLÍNICO ALEATORIZADO Y DOBLE CIEGO PARA MEDIR LA EFICACIA DE ACTAEA RACEMOSA (9CH) Y CAULOPHYLLUM THALICTROIDES (9CH) EN LA PRIMERA ETAPA DEL PARTO
    A.4.1Sponsor's protocol code numberBRN-C-2015-01
    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 SponsorBOIRONSIH
    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 supportBOIRONSIH
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQUANTUM EXPERIMENTAL, S.L.
    B.5.2Functional name of contact pointCLINICAL TRIAL INFORMATION
    B.5.3 Address:
    B.5.3.1Street AddressCarril de la Condesa Nº 58, Edificio Torre Proconsa, oficina 505
    B.5.3.2Town/ cityMURCIA
    B.5.3.3Post code30010
    B.5.3.4CountrySpain
    B.5.4Telephone number34-665036459-
    B.5.6E-mailivasallo@quantumexperimental.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.2.1.1.1Trade name Actaea racemosa (9CH)
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios Boiron SIH S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Granules
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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.2.1.1.1Trade name Caulophyllum thalicthroides (9CH)
    D.2.1.1.2Name of the Marketing Authorisation holderBOIRON SIH S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Granules
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboGranules
    D.8.4Route of administration of the placeboSublingual use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    First stage of labor
    Primera etapa del parto
    E.1.1.1Medical condition in easily understood language
    First stage of labor
    Primera etapa del parto
    E.1.1.2Therapeutic area Not possible to specify
    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
    Determine the efficacy of treatment with Actaea racemosa (9CH) and Caulophyllum thalicthroides (9CH) from the 37th week of pregnancy in the first stage of labor compared with placebo treatment.
    Determinar la eficacia del tratamiento con Actaea racemosa (9CH) y Caulophyllum thalicthroides (9CH) a partir de la semana 37 de gestación en la primera etapa del parto comparado con el tratamiento con placebo.
    E.2.2Secondary objectives of the trial
    Analyze the duration of latent phase in the group of women who take homeopathic treatment compared to the group taking placebo.
    2. Analyze the total duration of labor
    3. To analyze the evolution of cervical ripening
    4. Analyze the proportion of instrumental delivery being made after the homeopathic treatment compared to the placebo group.
    5. Analyze the proportion of caesarean sections, complications during labor, premature rupture of membranes and use of oxytocin during labor,
    6. Analyze the vitality of the newborn of mothers who took homeopathic medicines and mothers who took the placebo.
    7. Analyze the participant satisfaction after taking the homeopathic treatment compared to the group taking the placebo once delivery is completed.
    8. To analyze the safety and tolerability of the investigational treatments.
    1. Analizar la duración de la fase latente en el grupo de mujeres que toma tratamiento homeopático en comparación con el grupo que toma placebo.
    2. Analizar la duración total del parto
    3. Analizar la evolución de la maduración cervical
    4. Analizar la proporción de partos instrumentados que se realizan tras el tratamiento homeopático comparado con el grupo tratado con placebo.
    5. Analizar la proporción de cesáreas, complicaciones durante el parto, rotura prematura de membranas y uso de oxitocina durante el trabajo de parto,
    6. Analizar la vitalidad del recién nacido de las madres que tomaron los medicamentos homeopáticos y de las madres que tomaron el placebo.
    7. Analizar la satisfacción de la participante tras tomar el tratamiento homeopático comparado con el grupo que toma el placebo una vez finalizado el parto.
    8. Analizar la seguridad y tolerabilidad de los tratamientos en investigación.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Women above 18 years old.
    2. Pregnant women between 32 and 33 weeks gestation. The calculation of gestational age was performed using the date of the last rule corrected estimated by ultrasound parameters of the first ultrasound age. If the estimated age by ultrasound exceeds 7 days estimated by last menstrual period, it will assume the sonographically estimated as correct.
    3. Carrier single fetus in cephalic presentation at the time of recruitment.
    4. Compliance of pregnant women to participate in this study by signing the informed consent.
    1. Mujeres de edad superior a 18 años.
    2. Embarazadas de entre 32 y 33 semanas de gestación. El cálculo de la edad gestacional se realizará utilizando la fecha de la última regla corregida con la edad estimada por los parámetros ecográficos de la primera ecografía. Si la edad estimada por ecografía supera en 7 días a la estimada mediante fecha de última regla, se asumirá como correcta la estimada ecográficamente.
    3. Portadora de feto único en presentación cefálica en el instante del reclutamiento.
    4. Conformidad de la gestante a participar en este estudio mediante la firma del consentimiento informado.
    E.4Principal exclusion criteria
    1. Women who have undergone cesarean in a previous pregnancy.
    2. Women who are being treated with medications for chronic disease.
    3. Women who have had gestational diabetes during this pregnancy (diabetes, hypertension, urinary tract infection present, severe anemia) and / or present a pregnancy of moderate / high risk.
    4. Presence of fetal pathology (malformations, intrauterine growth retardation, etc.)
    5. Presence of placental abnormalities (single umbilical artery, placental insufficiency, placenta previa, etc.)
    6. Presence of current or resolved in less than 15 days time fetal or maternal infection.
    7. Bleeding disorder mother of the third quarter.
    8. Women with severe mental illness.
    9. Women who have decided to give birth by elective Caesarean section.
    10. Women who suffer from lactose intolerance.
    11. Women whose condition does not make them eligible for the study, according to the researcher.
    1. Mujeres a las que se les hayan practicado cesárea en embarazos anteriores.
    2. Mujeres que estén siendo tratadas con medicamentos por enfermedad crónica.
    3. Mujeres que hayan padecido patología gestacional durante el presente embarazo (diabetes, hipertensión, infección actual del tracto urinario, anemia grave) y/o presenten un embarazo de moderado/alto riesgo.
    4. Presencia de patología fetal (malformaciones, retraso del crecimiento intrauterino, etc.)
    5. Presencia de alteraciones placentarias (arteria umbilical única, insuficiencia placentaria, placenta previa, etc.)
    6. Presencia de infección fetal o materna actual o resuelta en un tiempo inferior a 15 días.
    7. Trastorno hemorrágico materno del tercer trimestre.
    8. Mujeres con enfermedad mental grave.
    9. Mujeres que hayan decidido parir mediante cesárea electiva.
    10. Mujeres que padezcan intolerancia a la lactosa.
    11. Mujeres cuya condición no les hace elegibles para el estudio, según el investigador.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the duration of the first stage of labor.
    La variable principal de valoración es el tiempo de duración de la primera etapa del parto.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the first satage of labor
    Durante la primera etapa del parto
    E.5.2Secondary end point(s)
    ? Duration latent phase of the first stage of labor
    ? total time duration of labor
    ? Changes in cervical ripening: Test score modified Bishop.
    ? Administration of oxytocin as a regulator of the dynamic once work has started spontaneously birth:
    ? Evaluation of the use of
    ? Cesarean: Complications during delivery:
    ? Premature rupture of membranes:
    ? Induction of labor (drugs, Hamilton maneuver, amniotomy, etc): Type of anesthesia used during delivery and instant start.
    ? instrumental delivery:
    ? APGAR test score at one minute and five minutes of birth.
    ? Height, weight and head circumference of the newborn.
    ? Satisfaction survey of pregnant women.
    ? Clinical Obstetric history:
    ? socio-demographic variables:
    ? blood safety variables: liver function (transaminases), renal profile (creatinine and urea) and CBC.
    ? Incidence and severity of adverse events during the study.
    ? Tiempo de duración la fase latente de la primera etapa del parto
    ? Tiempo de la duración total del parto
    ? Evolución de la maduración cervical: Puntuación del Test de Bishop modificado.
    ? Administración de oxitocina como regulador de la dinámica una vez que se ha iniciado el trabajo del parto de forma espontánea:
    ? Evaluación del uso de
    ? Cesáreas: Complicaciones durante el parto:
    ? Rotura prematura de membranas:
    ? Inducción al parto (fármacos, maniobra de Hamilton, amniotomía, etc): Tipo de anestesia utilizada en el parto e instante de inicio.
    ? Partos instrumentados:
    ? Puntuación del test de APGAR al minuto y a los 5 minutos del nacimiento.
    ? Talla, peso y perímetro cefálico del recién nacido.
    ? Cuestionario de satisfacción de la gestante.
    ? Antecedentes obstétricos clínicos:
    ? Variables socio-demográficas:
    ? Variables sanguíneas de seguridad: perfil hepático (Transaminasas), perfil renal (creatinina y urea) y hemograma.
    ? Incidencia y gravedad de los acontecimientos adversos ocurridos durante el estudio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During delivery
    Durante el parto
    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 No
    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) 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 concerned7
    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
    the last visit of the last subject undergoing the trial
    La última visita del último paciente incluido
    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 months6
    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: 114
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 No
    F.3.3.3Pregnant women Yes
    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 state114
    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
    No
    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 Decision2015-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-04-24
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