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    Summary
    EudraCT Number:2012-002547-15
    Sponsor's Protocol Code Number:UTM/2012
    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:2012-09-14
    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 number2012-002547-15
    A.3Full title of the trial
    UTILITY OF THE ocolytict MAINTENANCE TREATMENT IN THE MANAGEMENT OF THE THREAT OF PREMATURE
    UTILIDAD DEL TRATAMIENTO TOCOLÍTICO DE MANTENIMIENTO EN EL MANEJO DE LA AMENAZA DE PARTO PREMATURO (APP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    UTILITY OF THE ocolytict MAINTENANCE TREATMENT IN THE MANAGEMENT OF THE THREAT OF PREMATURE
    UTILIDAD DEL TRATAMIENTO TOCOLÍTICO DE MANTENIMIENTO EN EL MANEJO DE LA AMENAZA DE PARTO PREMATURO (APP
    A.4.1Sponsor's protocol code numberUTM/2012
    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 SponsorInstituto de Investigacion Sanitaria La Fe
    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 Investigacion Sanitaria La Fe
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstituto de Investigacion Sanitaria La Fe
    B.5.2Functional name of contact pointUREC
    B.5.3 Address:
    B.5.3.1Street AddressAv. Campanar
    B.5.3.2Town/ cityValencia
    B.5.3.3Post code46009
    B.5.3.4CountrySpain
    B.5.4Telephone number34963862758
    B.5.5Fax number34963494416
    B.5.6E-mailinvestigacion_clinica@iislafe.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 Progeffik 200 mg
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios EFFIK, 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 Vaginal capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPROGESTERONE
    D.3.9.1CAS number 57-83-0
    D.3.9.4EV Substance CodeSUB10076MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Yes
    D.2.1.1.1Trade name Adalat Oros
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER HISPANIA, S.L.
    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 Prolonged-release tablet
    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 INNNIFEDIPINE
    D.3.9.1CAS number 21829-25-4
    D.3.9.4EV Substance CodeSUB09253MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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
    Threat Preterm labor
    Amenza de parto prematuro
    E.1.1.1Medical condition in easily understood language
    Threat Preterm labor
    Ameza de parto anticipado
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    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
    To evaluate the perinatal and neonatal outcome
    Evaluar el desenlace perinatal y neonatal
    E.2.2Secondary objectives of the trial
    Objectify maternal side effects of nifedipine and progesterone
    Evaluate the outcome of pregnancy in women treated with nifedipine or with progesterone as maintenance tocolytic after an episode of APP which has been administered acute tocolysis and corticosteroids for lung maturation in full, compared with patients treated with placebo.
    Evaluar el desenlace de la gestación en mujeres tratadas con nifedipino o con progesterona como tocolítico de mantenimiento tras un episodio de APP en el que se ha administrado tocolisis aguda y corticoides para maduración pulmonar de forma completa, en comparación con pacientes tratadas con placebo.
    Objetivar los efectos secundarios maternos del nifedipino y de la progesterona.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Women with singleton pregnancies with intact membranes have passed an episode of APP (uterine contractions with cervical change) successfully treated with acute tocolysis with atosiban. Cervical length ? 25 mm
    Mujeres con gestaciones únicas con membranas intactas que hayan pasado un episodio de APP (contracciones uterinas con modificaciones cervicales) de forma exitosa tratado con tocolisis aguda con atosibán.
    Longitud cervical ? 25 mm.
    E.4Principal exclusion criteria
    Cervical dilation ? 3 cm, multiple gestation, maternal medical contraindication to tocolysis with nifedipine, atosiban or progesterone, or obstetric contraindication to tocolytic therapy (severe preeclampsia, intrauterine infection, placental abruption, fetal anomaly incompatible with life, fetal death).
    Dilatación cervical ?3 cm; gestación múltiple; contraindicación médica materna para tocolisis con nifedipino, atosibán o progesterona; o contraindicación obstétrica para tratamiento tocolítico (preeclampsia grave, infección intrauterina, desprendimiento prematuro de placenta, anomalía fetal incompatible con la vida, muerte fetal).
    E.5 End points
    E.5.1Primary end point(s)
    Decrease preterm delivery (before 37 weeks of gestation)
    Disminución parto pretérmino ( antes de la 37 semana de gestación)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At birth.
    En el parto
    E.5.2Secondary end point(s)
    Gestational age at birth (weeks), prolongation of pregnancy in women with APP (days), the presence of a recurrent episode of APP and the presence of more than one recurrent episodes of APP). It quantifies the number of women with PP before 34 weeks gestation, before 37 weeks and after 37 weeks
    La edad gestacional al nacimiento (semanas), la prolongación de la gestación en mujeres con APP (días), la presencia de un episodio de APP recurrente y la presencia de más de un episodios de APP recurrente). Se cuantificará el número de mujeres con PP antes de la 34 semanas de gestación, antes de la 37 semana y después de la 37 semana
    E.5.2.1Timepoint(s) of evaluation of this end point
    From the beginning of treatment, during the course of pregnancy and at delivery.
    A partir del inicio del tratamiento, durante el curso de la gestación y en el momento del 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 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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    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 months0
    E.8.9.1In the Member State concerned 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: 50
    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 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 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 state50
    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)
    it is not different from the expected normal treatment of that condition
    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 Decision2012-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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