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    Summary
    EudraCT Number:2015-001181-26
    Sponsor's Protocol Code Number:VPH-GXL-2013-01
    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:2015-06-01
    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 number2015-001181-26
    A.3Full title of the trial
    Evaluation of the impact of LacTEST on diagnostic thinking and on patient management, and of the reproducibility (Test-Retest), for the diagnosis of hypolactasia in adults and elderly patients presenting with clinical symptoms of lactose intolerance.
    Evaluación del impacto de LacTEST en el pensamiento diagnóstico y en el manejo terapéutico del paciente, y de reproducibilidad (Test-Retest), para el diagnóstico de la hipolactasia en adultos y población anciana que presenten síntomas clínicos de intolerancia a la lactosa.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of LacTEST for the diagnosis of hypolactasia in adults and elderly patients presenting with clinical symptoms of lactose intolerance.
    Evaluación del test de lactosa LacTEST como diagnóstico de la hipolactasia en adultos y población anciana que presenten síntomas clínicos de intolerancia a la lactosa.
    A.4.1Sponsor's protocol code numberVPH-GXL-2013-01
    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 SponsorVenter Pharma S.L.
    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 supportVenter Pharma; S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPivotal, S.L.
    B.5.2Functional name of contact pointPaz González
    B.5.3 Address:
    B.5.3.1Street AddressC/ Gobelas, 19
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28023
    B.5.3.4CountrySpain
    B.5.4Telephone number349170812501255
    B.5.5Fax number34917081301
    B.5.6E-mailpaz.gonzalez@pivotal.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 LacTEST 0,45g
    D.2.1.1.2Name of the Marketing Authorisation holderVenter Phama, 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.3.1Product nameGaxilose
    D.3.4Pharmaceutical form Powder and solvent for oral solution
    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 INNGAXILOSE
    D.3.9.3Other descriptive nameLacTEST
    D.3.9.4EV Substance CodeSUB172203
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.45
    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
    Evaluación del impacto de LacTEST en el pensamiento diagnóstico y en el manejo terapéutico del paciente, y de reproducibilidad (Test-Retest), para el diagnóstico de la hipolactasia en adultos y población anciana que presenten síntomas clínicos de intolerancia a la lactosa.
    Evaluation of the impact of LacTEST on diagnostic thinking and on patient management, and of the reproducibility (Test-Retest), for the diagnosis of hypolactasia in adults and elderly patients presenting with clinical symptoms of lactose intolerance.
    E.1.1.1Medical condition in easily understood language
    Lactose intolerance due to either primary or secondary hypolactasia (lactase deficiency).
    Intolerancia a la lactosa debida a hipolactasia (deficiencia de lactasa).
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    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 is to demonstrate non ?inferiority of Gaxilose test, compared with Hydrogen Breath Test (HBT) using a validated method, of the impact on diagnostic thinking for the diagnosis of hypolactasia.
    El objetivo primario es demostrar la no-inferioridad del test de Gaxilosa, en comparación con el Test de Hidrógeno Espirado (THE) usando un método validado, en el impacto en el pensamiento diagnóstico para el diagnóstico de la hipolactasia.
    E.2.2Secondary objectives of the trial
    1. to demonstrate non ?inferiority of Gaxilose test, compared with Hydrogen Breath Test (HBT), on the impact on patient management for the diagnosis of hypolactasia;
    2. to demonstrate Gaxilose test reproducibility with urine accumulated from 0-4h after Gaxilose administration;
    3. to demonstrate Gaxilose test reproducibility with urine accumulated from 0-5h after Gaxilose administration;
    4. safety assessments.
    1. Demostrar la no-inferioridad del test de Gaxilosa, en comparación con el THE, en el impacto en el manejo terapéutico del paciente para el diagnóstico de la hipolactasia.
    2. Demostrar la reproducibilidad del test de Gaxilosa con orina acumulada de 0-4h después de la administración de Gaxilosa.
    3. Demostrar la reproducibilidad del test de Gaxilosa con orina acumulada de 0-5h después de la administración de Gaxilosa.
    4. Evaluar la seguridad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adults of either sex, between 18 and 70 years old.
    2. Capacity for understanding and giving the informed consent to participate in this study.
    3. Patients with clinical suggestive of lactose intolerance, primary or secondary, who have not been diagnosed and that fulfil the requirements allowed by the Gaxilose summary of product characteristics
    1. Adultos de ambos sexos, de entre 18 y 70 años de edad.
    2. Capacidad de entender y dar el consentimiento informado para participar en este estudio.
    3. Pacientes con clínica sugerente de intolerancia a la lactosa primaria o secundaria, que no hayan sido diagnosticados y que cumplan los requisitos permitidos por la ficha técnica en vigor de Gaxilosa.
    E.4Principal exclusion criteria
    1. Pregnant women or breast-feeding women.
    2. Unable or reticent to give the informed consent or to comply with the study?s requirements.
    3. Severe renal insufficiency.
    4. Portal hypertension: ascites, cirrhosis.
    5. Medical records of total gastrectomy and/or vagotomy.
    6. Patients diagnosed with myxedema.
    7. Patients with Diabetes Mellitus.
    8. Patients who are participating or have participated in any clinical trial within the 3 months previous to their inclusion in the study.
    9. Patients who are drug abuse consumers.
    10. Patients under treatment with antibiotics, sulphamides and antiparasitics, who cannot suspend the treatments 7 days prior to the performance of the hydrogen breath test.
    11. Patients with any recognized and already existing disorder that might interfere with the any of the lactose intolerance diagnosis tests.
    12. Patients who have taken aspirin of indomethacin in the 48h preceding the performance of the Gaxilose test.
    13. Patients with glomerular filtration rate (GFR) less 90 ml/min/1.73 m2.
    1. Mujeres embarazadas o en periodo de lactancia.
    2. Incapacidad o reticencia a dar el consentimiento informado o a cumplir los requerimientos del estudio.
    3. Insuficiencia renal severa.
    4. Hipertensión portal: ascitis, cirrosis.
    5. Gastrectomía total y/o vagotomía.
    6. Pacientes diagnosticados con mixedema.
    7. Pacientes con Diabetes Mellitus.
    8. Pacientes que estén participando o hayan participado en cualquier ensayo clínico en los 3 meses previos a su inclusión es este estudio.
    9. Pacientes que abusen de drogas.
    10. Pacientes bajo tratamiento con antibióticos, sulfamidas, antiparasitarios, que no puedan suspender los tratamientos durante los 7 días previos a la realización del THE.
    11. Pacientes con cualquier desorden reconocido y ya existente que pueda interferir con cualquiera de los tests de diagnóstico de la intolerancia a la lactosa.
    12. Pacientes que hayan tomado aspirina o indometacina durante las 48h previas a la realización del test de Gaxilosa.
    13. Pacientes con tasa de filtración glomerular (TFG) inferior a 90 mL/min/1,73 m2.
    E.5 End points
    E.5.1Primary end point(s)
    To analyse the change in diagnostic certainty and in patient management consequent to HBT or Gaxilose test implementation in the clinical practice.
    Analizar el cambio en la certeza diagnóstica y en el manejo terapéutico del paciente que aparezca como consecuencia de la implementación del THE o del test de Gaxilosa en la práctica clínica.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Visual Analogue Scale (VAS) pre-test and post-test.
    - Intended management pre-test and post-test questionnaires.
    - Escala Analógica Visual (VAS) pre-test and post-test.
    - Cuestionarios de manejo terapéutico previsto pre-test y post-test
    E.5.2Secondary end point(s)
    Not applicable
    No aplicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplicable
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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) 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 Yes
    E.8.1.3Single blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Test de Hidrógeno Espirado (THE)
    Hydrogen Breath Test (HBT)
    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 concerned6
    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
    Útima visita, último paciente
    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 months2
    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: 144
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 144
    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 state144
    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)
    None
    Ninguno
    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 Decision2015-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-07
    P. End of Trial
    P.End of Trial StatusOngoing
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