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    Summary
    EudraCT Number:2012-004410-34
    Sponsor's Protocol Code Number:FOM_PER_1_12
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-10-29
    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 number2012-004410-34
    A.3Full title of the trial
    Influence of timolol maleate (ophthalmic gel 1 mg/g) on the keratometry and the parameters of corneal biomechanics in patients with keratoconus.
    Influencia del maleato de timolol (gel oftálmico 1mg/g) en la queratometría y parámetros de biomecánica corneal en pacientes con queratocono.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of timolol maleate on general structural characteristics of the cornea in patients with keratoconus (abnormal conical shape of the cornea).
    Efecto del maleato de timolol sobre las caracteristicas estructurales de la córnea en pacientes con queratocono (deformación anormal de la córnea).
    A.4.1Sponsor's protocol code numberFOM_PER_1_12
    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 SponsorCristina Peris Martínez
    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 supportFundacion Oftalmológica del Mediterráneo
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCristina Peris Martínez
    B.5.2Functional name of contact pointCristina Peris Martínez
    B.5.3 Address:
    B.5.3.1Street AddressBifurcación Pio Baroja-General Avilés
    B.5.3.2Town/ cityValencia
    B.5.3.3Post code46015
    B.5.3.4CountrySpain
    B.5.4Telephone number34962328100
    B.5.5Fax number34962328102
    B.5.6E-mailperis_crimar@gva.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 Timogel 1mg/g 30 monodosis
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoires Théa
    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 Eye drops, solution in single-dose container
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTimolol maleate
    D.3.9.1CAS number 26921-17-5
    D.3.9.3Other descriptive nameTIMOLOL MALEATE
    D.3.9.4EV Substance CodeSUB04875MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number1
    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 Hidrathea
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoires Théa
    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 nameHidrathea
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOphthalmic use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium Chloride
    D.3.9.1CAS number 7647-14-5
    D.3.9.3Other descriptive nameSODIUM CHLORIDE SOLUTION 0.9%
    D.3.9.4EV Substance CodeSUB20079
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number0.9
    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
    Keratoconus
    Queratocono
    E.1.1.1Medical condition in easily understood language
    Pathological conical shape of the cornea
    Deformación cónica de la cornea de origen patológico
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10023353
    E.1.2Term Keratoconus
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - Decrease in the keratometry measurement in patients with keratoconus.

    - Improvement in the corneal biomechanic parameters (corneal hysteresis-CH and corneal resistance factor-CRF) in patients with keratoconus.
    -Reducción de la la queratometría en pacientes con queratocono.

    -Mejora de los parámetros de biomecánica corneal (histéresis corneal-CH y factor de resistencia corneal-CRF) en pacientes con queratocono.
    E.2.2Secondary objectives of the trial
    -Determination of a possible relationship between the improvement of keratometry and corneal biomechanic parameters and the decrease of the intraocular pressure.

    -Establish de safety of timolol maleate treatment in patients with keratoconus.
    -Determinación de la posible correlación entre el grado de reducción de la queratometría, CH, CRF y el grado de reducción de la PIO en estos pacientes.

    -Establecer la seguridad del tratamiento con maleato de timolol en pacientes con queratocono.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female, from 18 years of age.
    2.Patients with keratoconus grade I, II, or III on the Amsler-Krumeick scale
    3.Patient must provide written informed consent.
    1. Hombres o mujeres de 18 años o mayores.
    2. Pacientes con queratocono grado I, II, III según clasificación de Amsler-Krumeich
    3. Pacientes que hayan dado el consentimiento informado por escrito en el que se explicará qué tipo de pruebas han de realizar
    E.4Principal exclusion criteria
    1.Patient with keratoconus grade IV on the Amsler-Krumeick
    2.Any other ectasia including secundary ioatrogenic ectasia after Lasik surgery, radial keratotomy, traumatic ectasia, etc.
    3.Lid anatomic or functional anomaly affecting blinking function
    4. Any ocular or systemic pathology affecting the normal ocular function and interfering with study results.
    5. Contact lenses wear at the inclusion visit and for whole study time.
    6. Any corneal surgery.
    7. Any ocular surgery including refractive surgery, intraocular surgery or lid surgery, modifying the corneal surface of the patients.
    8. History of any ocular trauma, ocular inflammation or ocular infection (viral, bacterial, fungal, protozoal).
    9. Within the 30 days before the Screening Visit history of any ocular pathology requesting topical treatment.
    10. Patients with glaucoma or ocular hypertension
    11. Medical history of corneal dystrophy or showing the pathology at the selection visit.
    12. Best corrected distance visual acuity (BCDVA) score ? 35 ETDRS letters or ? 20/200 Snellen.
    13. Patients using systemic or ocular treatment for glaucoma or ocular hypertension, including other beta-blockers agents
    14. Patients using any other treatment which increases or decreases intraocular pressure
    15. Patients using any eye drop containing adrenaline
    16. Presence or history of cancer, other serious diseases and metabolic serious diseases.
    17. Patient with aggressive treatment since last year.
    18. Patient with not controlled disease since 6 months (arterial hypertension, thyroid dysfunction, autoimmune disease, patients with improper metabolic control including out range glycaemia.
    19. Presence or history of respiratory disease of asthma, COPD, bronchial hyperactivity, allergic rhinitis.
    20. Presence or history of cardiovascular diseases such as cardiac insufficiency, cardiogenic shock, 2nd and 3th degree AV block, bradycardia, Reynaud disease, peripheral circulation distress, hypotension
    21. Patients with pheochromacytoma
    22. Presence or history of metabolic acidosis
    23. Presence or history of psoriasis
    24. Medical history of anaphylactic reaction
    25 Any change on systemic within 30 days before to the screening visit, or any unexpected change of medication during the whole study
    26. Patients with allergic response to study drugs, to study related drugs or to drugs used during study procedures
    27. Medical history of neoplastic disease in last 5 years
    28. Pregnant or child feeding women
    29. Childbearing women not using contraception methods
    30. Patients being treated with floctafenin and sultopride or having treated with them in the last 30 days before inclusion visit
    31. Patients receiving systemic treatment of bepridil, verapamil and/or diltiazem or having used them in the last 30 days before inclusion visit
    32. Patients receiving systemic treatment of beta-blockers or having used them in the last 30 days before inclusion visit
    33. Patients receiving any systemic treatment having negative effect on cardiac conductibility (amiodarone, propafenone, anti-bradicardia agents, etc) or having used them in the last 7 days before inclusion visit
    34. Patients receiving any systemic treatment increasing the beta-blocking or hypotensive effect (quinidine, baclofen, imipramine, etc) or having used them in the last 7 days before inclusion visit
    35. Patients receiving any systemic treatment having antihypertensive effect (central hypertensive drugs, NSAID, dipiramidol) or having used them in the last 7 days before inclusion visit
    1. Ojos con queratocono avanzado (grado IV de Amsler).
    2. Ojos con otras ectasias, incluyendo las iatrogénicas secundarias a cirugía de superficie ocular con láser excimer, quratotomía radial, traumáticas, etc…
    3. Anatomía palpebral o función de parpadeo alterada.
    4. Cualquier patología ocular o sistémica con repercusión ocular que pudiera interferir en la interpretación de los resultados el estudio.
    5. Pacientes portadores de lentes de contacto en la visita de inclusión y durante la totalidad del estudio.
    6. Ojos sometidos a cirugía corneal.
    7. Cualquier cirugía ocular (incluyendo cirugía refractiva con láser, cirugías intraoculares y cirugías palpebrales) que pueda modificar la superficie corneal de los pacientes.
    8. Historia de traumatismo ocular, infección, inflamación ocular,…
    9. Cualquier enfermedad ocular que requiera tratamiento tópico durante 1 mes previo al estudio.
    10. Ojos con glaucoma establecido o hipertensión ocular asociada.
    11. Ojos con antecedentes o presentando cualquier tipo de distrofia corneal.
    12. Ojos con una agudeza visual corregida ≤ 35 EDTRS ó ≤20/200 Snellen.
    13. Pacientes usando fármacos para el tratamiento de la hipertensión ocular o glaucoma a nivel tópico, incluidos otros fármacos tópicos conteniendo beta-bloqueantes.
    14. Pacientes en tratamiento con otros fármacos que reduzcan o aumenten la tensión ocular de manera probada.
    15. Pacientes en tratamiento con preparaciones farmacéuticas tópicas conteniendo adrenalina.
    16. Pacientes padeciendo o habiendo padecido cáncer, otras enfermedades graves o enfermedades metabólicas graves.
    17. Pacientes recibiendo o habiendo recibido tratamiento agresivo durante el último año.
    18. Pacientes con una enfermedad no estabilizada en un periodo de al menos 6 meses antes de la visita de selección (hipertensión arterial descontrolada, mal funcionamiento de la tiroides, enfermedad autoinmune no controlada, pacientes con control metabólico inadecuado incluyendo una glicemia fuera de rango).
    19. Pacientes con antecedentes o presentando trastornos respiratorios como asma, EPOC, hiperreactividad bronquial, rinitis alérgica, etc.
    20. Pacientes con antecedentes o presentando trastornos cardiovasculares como insuficiencia cardíaca, shock cardiogénico, bloqueo aurículoventricular de 2º y 3er grado, angina prinzmatal, enfermedad del seno, bloqueo senoauricular, bradicardia, enfermedad de Reynaud, alteraciones de circulación periférica, hipotensión, etc.
    21. Pacientes presentando feocromocitona sin tratamiento.
    22. Pacientes con antecedentes o presentando acidosis metabólica.
    23. Pacientes con antecedentes o presentando psoriasis.
    24. Presencia o antecedentes reacción anafiláctica grave.
    25. Cualquier cambio de medicación sistémica dentro de los 30 días previos a la visita de selección o cualquier cambio no previsto durante el transcurso del estudio.
    26. Pacientes con hipersensibilidad conocida a los componentes del producto o de la misma familia o que se utilizan en los procedimientos/exámenes exploratorios.
    27. Pacientes con antecedentes de enfermedad neoplásica en los últimos 5 años.
    28. Mujeres embarazadas o lactantes
    29. Mujeres con capacidad de procrear sin tratamiento anticonceptivo
    30. Pacientes bajo tratamiento sistémico con preparaciones farmacéuticas conteniendo floctafenina y sultoprida o que hayan sido tratados con estos principios activos hace menos de 30 días respecto a la visita de inclusión.
    31. Pacientes bajo tratamiento sistémico con preparaciones farmacéuticas conteniendo bepridilo, verapamilo y/o diltiazem o que hayan sido tratados con estos principios activos hace menos de 30 días respecto a la visita de inclusión
    32. Pacientes bajo tratamiento sistémico con preparaciones farmacéuticas conteniendo beta-bloqueantes o que hayan sido tratados con ellos hace menos de 30 días respecto a la visita de inclusión.
    33. Pacientes bajo tratamiento sistémico con preparaciones farmacéuticas conteniendo cualquier fármaco que pueda alterar la contractibilidad, el automatismo y la conducción cardíaca (amiodarona, propafenona, fármacos antibradicárdicos, etc.) o que haya sido tratados con ellos hace menos de 7 días respecto a la visita de inclusión.
    34. Pacientes bajo tratamiento sistémico con preparaciones farmacéuticas conteniendo cualquier fármaco que potencie el efecto beta-bloqueante o hipotensivo (quinidina, baclofeno, antidepresivos imipramínicos, neurolépticos, dihidropiridinas, pilocarpina, amifostina, alfa-bloqueantes de uso urológico) o que haya sido tratados con ellos hace menos de 7 días respecto a la visita de inclusión.
    35. Pacientes bajo tratamiento sistémico con preparaciones farmacéuticas conteniendo fármacos con capacidad antihipertensivos (antihipertensivos centrales, AINES, dipiramidol) o que haya sido tratados con ellos hace menos de 7 días respecto a la visita de inclusión.
    E.5 End points
    E.5.1Primary end point(s)
    -Achieving the decrease on the patient keratometry. Decrease of at least 1 grade from baseline measurement will be considered as probed efficiency.

    -Improving corneal biomechanic parameters (corneal hysteresis and corneal resistance factor): a decrease from baseline on biomechanic parameters of at least 30% will be considered as efficient.
    -Conseguir un grado de reducción de la queratometría en pacientes con queratocono de grado I, II, ó III: reducción de al menos 1 grado se considerará como eficaz.

    -Mejora de los parámetros de biomecánica corneal (histéresis corneal-CH y factor de resistencia corneal-CRF) en pacientes con queratocono. La obtención de una reducción de al menos un 30% respecto a los valores basales, se considerará eficaz.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Analysis of both primary variable of clinic efficiency, keratometry and corneal biomechanic parameters, will be performed at last visit, visit 5 on month 6.
    El análisis de las dos variables de eficacia primaria se valorarán en la última visita (visit 5/mes 6).
    E.5.2Secondary end point(s)
    - Establishing the possible relationship between improvement of keratometry, and corneal biomechanic parameters and decrease in the intraocular pressure.

    - Establishing the safety of the treatment, showing treatment effects on corneal epithelium.
    - Establecer la posible correlación entre el grado de reducción de los valores de los parámetros de queratometría, histéresis corneal (CH) y factor de resistencia corneal (CRF), y el grado de reducción de la presión intraocular (PIO).

    - Establecer la seguridad del producto por observación de la integridad epitelial corneal.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Measurements and analysis of all secundary variable will be performed during complete study trial at visit 2, 3, 4 and 5
    Las medidas y análisis de las variables secundarias se llevaran a cabo durante la totalidad del estudio (visita 2, 3, 4 y 5)
    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 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 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.8.2.4Number 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
    The end of the study has been programmend 6 months after D0. Once the study is finished, protocol does not plan any other optional follow-up visit, except in specific cases (SAE ongoing). PI as sponsor of the study can terminate the study at any time if problems of security, ethics, etc are observed. In that case termination must be communicated to CCAA.
    Se considera que el fin del estudio será a los 6 meses de la visita de inclusión del último paciente incluido (última visita de seguimiento del último paciente reclutado). Después el protocolo no prevé ninguna visita opcional de seguimiento, excepto si es necesario (seguimiento de AA graves no resueltos).
    El investigador principal y promotor del estudio podrá terminar el estudio en cualquier momento (seguridad, futilidad, ética, administrativa) notificandolo por escrito a las AACC.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state30
    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)
    In case of general and especific results of the study were positif and investigators can really observe a significant improvement on keratocunus on the study patients, he can decide continuing with using timolol maleate as treatment for controling the pathology. The investigator, in base of obtained results, will decide for each particular case before prescriving the treatment to the patient.
    En el caso que los resultados globales e individuales sean positivos y se observe una mejora significativa del grado de queratocono en los pacientes del estudio, el investigador podrá usar el maleato de timolol como tratamiento para el control de la enfermedad. El investigador, según los resultados obtenidos, valorará cada caso de forma individual antes de someter al paciente a dicho tratamiento.
    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 Decision2013-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-29
    P. End of Trial
    P.End of Trial StatusCompleted
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