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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2006-006318-14
    Sponsor's Protocol Code Number:MON-E-14
    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:2007-02-27
    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 number2006-006318-14
    A.3Full title of the trial
    Evaluación de una nueva pauta terapéutica con Fosfomicina trometamol en el tratamiento de las ITUs bajas de la mujer postmenopáusica.
    Estudio multicéntrico, aleatorizado, prospectivo y controlado, comparativo entre fosfomicina trometamol en pauta de 2 dosis separadas por 72 horas, versus pauta corta de 3 días de ciprofloxacino.
    A.4.1Sponsor's protocol code numberMON-E-14
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPharmazam, S.A.
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 MONUROL 3 gr
    D.2.1.1.2Name of the Marketing Authorisation holderPHARMAZAM
    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 Powder for oral solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 Ciprofloxacino EFG
    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 Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Evaluar la eficacia y la seguridad de una nueva pauta terapéutica de Fosfomicina trometamol (dos dosis de 3 g separadas por 72 horas) en el tratamiento de las infecciones urinarias bajas de la mujer postmenopáusica, en comparación a la pauta corta de 3 días de ciprofloxacino, como tratamiento de referencia.
    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
    - Evaluar la eficacia y la seguridad de una nueva pauta terapéutica de Fosfomicina trometamol (dos dosis de 3g separadas por 72 horas) en el tratamiento de las infecciones urinarias bajas de la mujer postmenopáusica, en comparación a la pauta corta de 3 días de ciprofloxacino, como tratamiento de referencia.
    E.2.2Secondary objectives of the trial
    - Comparar los dos tratamientos en términos de erradicación bacteriana de los uropatógenos inicialmente resistentes al tratamiento asignado, en la visita 2 al finalizar el tratamiento antibiótico.
    - Comparar los dos tratamientos en términos de tiempo transcurrido desde el inicio de la toma de la medicación en estudio hasta la desaparición de los síntomas clínicos de ITU baja (evaluación en control telefónico a los 2-4 días de iniciar el tratamiento y en visita 2 a los 5-9 días de finalizar el tratamiento).
    - Comparar los dos tratamientos en términos de curación clínica de las ITUs bajas de la mujer postmenopáusica, en la visita 2, tras finalizar el tratamiento antibiótico.
    - Comparar el porcentaje de recaídas y/o reinfecciones ocurridas a las 4-6 semanas de finalizar el tratamiento en cada uno de los dos grupos de estudio.
    - Evaluar la remisión espontánea de la bacteriuria asintomática post-tratamiento, evidenciada en la visita 2 y evaluada en la visita 3.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Paciente postmenopáusica, con menopausia natural, inducida o precoz (mínimo de 12 meses sin menstruaciones), de edad igual o superior a 60 años.
    - Paciente con presencia de signos y síntomas clínicos de ITU baja (p.ej.: disuria, frecuencia, urgencia, dolor suprapúbico) de inicio ≤ a 72 horas previas a la inclusión en el estudio.
    - Paciente con cultivo de orina positivo, de muestra recogida bajo condiciones normales de asepsia y dentro de las primeras 24 horas desde su inclusión en el estudio (el cultivo de orina se define como positivo si el recuento de bacterias es > 103 UFC/mL en presencia de síntomas y de leucocituria positiva41,42). Si se identifica más de un patógeno, éstos solo serán incluidos en estudio si tiene una presencia >105 UFC/mL en el recuento de colonias.
    - Pacientes capaces de comunicarse correctamente con el personal del estudio y capaces de entender y leer con fluidez el lenguaje local.
    - Pacientes de las que se ha obtenido el consentimiento informado.
    E.4Principal exclusion criteria
    - Pacientes con síntomas de ITU baja de más de una semana de duración.
    - Pacientes con signos y síntomas clínicos sugestivos de infección del tracto urinario superior: Fiebre (T>38ºC), escalofríos, malestar general, náuseas y/o vómitos, dolor de espalda o molestias lumbares.
    - Pacientes que presenten una ITU baja intratable o complicada que requiera una pauta terapéutica de ≥7 días de tratamiento.
    - Pacientes con alguna contraindicación a la toma de fosfomicina o de ciprofloxacino.
    - Pacientes con hipersensibilidad conocida a fosfomicina o a ciprofloxacino o bien a alguno de los componentes de los preparados en estudio.
    - Pacientes en tratamiento antibiótico durante las 48 horas previas a su inclusión en el estudio.
    - Pacientes portadoras de sonda vesical.
    - Pacientes con vejiga neurogénica o evidencia clínica conocida de uropatía obstructiva causada por nefrolitiasis, tumor o fibrosis.
    - Pacientes con historia conocida de deterioro renal grave indicada por valores de creatinina superiores a los límites de normalidad, o bien que hayan sido sometidas a un transplante renal.
    - Pacientes con retención de orina residual severa.
    - Pacientes con síntomas de vaginitis activa sintomática.
    - Pacientes con evidencia clínica conocida o analítica de disfunción hepática (GOT y GPT superior al doble del valor límite superior del rango normal).
    - Pacientes diabéticas.
    - Pacientes inmunodeprimidas (leucocitos<1.000/mm3).
    - Pacientes de las que se sospeche una bajo cumplimiento predecible.
    - Participación en un ensayo clínico con un fármaco no registrado diferente en un plazo de 30 días al comienzo del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Porcentaje de erradicación bacteriana tras finalizar el tratamiento antibiótico (resultado bacteriológico en V2).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned8
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state224
    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 Decision2007-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-02-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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