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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   42883   clinical trials with a EudraCT protocol, of which   7063   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).

    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2016-004021-16
    Sponsor's Protocol Code Number:FIM-PXE-2016-01
    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:2017-03-10
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2016-004021-16
    A.3Full title of the trial
    Response to oral lansoprazole in inorganic pyrophosphate levels in patients with Grönblad-Stranberg disease (Pseudoxanthoma Elasticum)
    Respuesta al lansoprazol oral de los niveles del pirofosfato inorgánico en pacientes con enfermedad de Grönblad-Stranberg (Pseudoxantoma Elasticum)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Response to oral lansoprazole in patients with Pseudoxanthoma Elasticum
    Respuesta al lansoprazol oral en pacientes con Pseudoxantoma Elasticum
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberFIM-PXE-2016-01
    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 SponsorFundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS)
    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 supportFIMABIS
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFIMABIS
    B.5.2Functional name of contact pointGloria Luque
    B.5.3 Address:
    B.5.3.1Street AddressCalle Doctor Miguel Díaz Recio 28 local
    B.5.3.2Town/ cityMálaga
    B.5.3.3Post code29010
    B.5.4Telephone number+34951291977
    B.5.5Fax number+34951440263
    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. name Lansoprazole
    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 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 INNLansolprazole
    D.3.9.1CAS number 103577-45-3
    D.3.9.3Other descriptive nameLANSOPRAZOLE
    D.3.9.4EV Substance CodeSUB08403MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Grönblad-Stranberg disease (Pseudoxanthoma Elasticum)
    Enfermedad de Grönblad-Stranberg (Pseudoxantoma Elasticum)
    E.1.1.1Medical condition in easily understood language
    Grönblad-Stranberg disease (Pseudoxanthoma Elasticum )
    Enfermedad de Grönblad-Stranberg (Pseudoxantoma Elasticum)
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10037150
    E.1.2Term Pseudoxanthoma elasticum
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Verify the changes in plasmatic PPi and the main molecules that regulate them (ENPP1-3, TNAP) after oral administration of lansoprazole in patients with Pseudoxanthoma Elasticum (PXE).
    Verificar los cambios del PPi plasmático, y las principales moléculas que los regulan (ENPP1-3, TNAP) tras la administración oral de lansoprazol en pacientes con diagnóstico de Pseudoxantoma Elasticum (PXE).
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.- Patients ≥18 years diagnosed of PXE according to the 2010 criteria of PLOMP et al (10) in follow-up at the Internal Medicine Consultation of the Virgen de la Victoria Hospital in Málaga and at the Internal Medicine Consultation of the Hospital Virgen de la Macarena de Sevilla and that meet at least two of the following criteria:
    A. Retinal lesions peau d'orange type and / or angioid streaks.
    B. Skin lesions consisting of papules or yellowish plaques on the lateral side of the neck and / or body flexures (axilary folds, elbows, knees) or alterations in the skin biopsy with fragmentation and / or conglomerates of and / or elastic fiber calcification.
    C. A pathogenic mutation of the two alleles of the ABCC6 gene.
    1.- Pacientes ≥18 años diagnosticados de PXE según los criterios de 2010 de PLOMP et al (10) en seguimiento en la Consulta de Medicina Interna del Hospital Virgen de la Victoria de Málaga y en la Consulta de Medicina Interna del Hospital Virgen de la Macarena de Sevilla y que cumplan, al menos, dos de los siguientes criterios:
    A. Lesiones retinianas del tipo de piel de naranja y/o estrías angioides.
    B. Lesiones cutáneas consistentes en pápulas o placas amarillentas en la cara lateral del cuello y/o flexuras del cuerpo (axilas, codos, rodillas) o alteraciones en la biopsia de piel con fragmentación y/o conglomerados de y/o calcificación de las fibras elásticas.
    C. Una mutación patogénica de los dos alelos del gen ABCC6.
    E.4Principal exclusion criteria
    1.- Refuse to give informed consent.
    2.- Vegetarian diet or extreme diets.
    3.- Pregnancy or intention during study period.
    4.- Age <18 years.
    5.- Known hypersensitivity to "prazoles" or proton pump inhibitors.
    6.- Ingestion of medications that may interfere with PPIs (antifungal and atazanavir).
    7.- Previous treatment with proton pump inhibitors, except for a 15 day wash period if the patient's clinical situation allows it
    1.- Negativa al consentimiento informado.
    2.- Dieta vegetariana o dietas extremas.
    3.- Embarazo o intención del mismo en los meses de duración del estudio.
    4.- Edad < 18 años.
    5.- Hipersensibilidad conocida a los medicamentos tipos “prazoles” o inhibidores de la bomba de protones.
    6.- Ingesta de medicamentos que puedan interferir con los IBP (antifúngicos y atazanavir).
    7.- Toma previa de inhibidores de la bomba de protones, salvo periodo de lavado de 15 días si la situación clínica del paciente lo permite
    E.5 End points
    E.5.1Primary end point(s)
    Verify the changes in plasmatic PPi and the main molecules that regulate them (ENPP1-3, TNAP) after oral administration of lansoprazole in patients with Pseudoxanthoma Elasticum (PXE).
    Verificar los cambios del PPi plasmático, y las principales moléculas que los regulan (ENPP1-3, TNAP) tras la administración oral de lansoprazol en pacientes con diagnóstico de Pseudoxantoma Elasticum (PXE).
    E.5.1.1Timepoint(s) of evaluation of this end point
    8th and 16th week
    Semanas 8 y 16
    E.5.2Secondary end point(s)
    Not applicable
    No aplica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplica
    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 Yes
    E.6.4Safety No
    E.6.5Efficacy No
    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. 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 No
    E.8.1.6Cross over Yes
    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 concerned2
    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
    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 months24
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state20
    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)
    Patients will continue to receive our medical follow-up, and will received best treatment available.
    Los pacientes seguirán recibiendo nuestro seguimiento médico y recibirán el mejor tratamiento disponible
    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 Decision2018-10-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-23
    P. End of Trial
    P.End of Trial StatusOngoing
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