Prove cliniche Nct

Summary
EudraCT Number:2004-003215-22
Sponsor's Protocol Code Number:vit-001
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:2005-11-03
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
A. Protocol Information
A.1Member State ConcernedSpain - AEMPS
A.2EudraCT number2004-003215-22
A.3Full title of the trial
Ensayo clínico piloto, unicéntrico, aleatorizado, doble ciego, con dos grupos paralelos sobre el efecto del Tacalcitol en pacientes afectos de vitíligo.
A.4.1Sponsor's protocol code numbervit-001
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 SponsorAntonio Noda Cabrera
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 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 Information not present in EudraCT
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 nameBonalfa (0'0004% pomada 50 g)
D.3.2Product code 7069034
D.3.4Pharmaceutical form Ointment
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPCutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNTACALCITOL
D.3.10 Strength
D.3.10.1Concentration unit µg microgram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number4
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin No
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 Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
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 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 placeboOintment
D.8.4Route of administration of the placeboCutaneous use
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
vitiligo vulgaris
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 5.0
E.1.2Level NEC
E.1.2Classification code 10040829
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
Estudiar el efecto de tacalcitol en la repigmentación de las lesiones por vitiligo vulgaris
E.2.2Secondary objectives of the trial
A) Evaluar la eficacia de tacalcitol según la pertenencia del paciente a alguno de los siguientes subgrupos:
1)Duración de la enfermedad (< 5 años ó < 5 años).
2)Presencia de anticuerpos circulantes.
3)Presencia de fenómeno de Koebner +.

B) Evaluar la tolerabilidad y seguridad del tacalcitol durante los 120 días de tratamiento.
E.2.3Trial contains a sub-study Information not present in EudraCT
E.3Principal inclusion criteria
1)Pacientes de ambos sexos igual o mayor de 18 años
2)Pacientes afectos de vitíligo vulgar en zonas distintas a cara y región genital.
3)El paciente ha dado su consentimiento.
4)El paciente es capaz de seguir el período de tratamiento
E.4Principal exclusion criteria
1)Embarazo o lactancia materna; rechazo a permanecer con anticoncepción fiable durante el periodo del tratamiento.
2)Pacientes con hipercalcemia conocida u otras alteraciones del metabolismo óseo.
3)Enfermedades activas o crónicas que el investigador considere motivo de no participación.
4)Pacientes que precisen tratamiento con fármacos que puedan causar fotosensibilidad, como por ejemplo las tiacidas.
5)Hipersensibilidad alérgica conocida al tacalcitol o cualquier fármaco similar.
6)Insuficiencia renal moderada a grave.
Pacientes que participen en otro ensayo clínico.
E.5 End points
E.5.1Primary end point(s)
A)Variable principal de evaluación.

La variable principal es el área de repigmentación de las lesiones de vitíligo, calculada a partir de la medición de las fotografías mediante un procedimiento informático.

B)Variables secundarias a estudiar.

1) Repigmentación en zonas que no se hallan incluidas en el estudio: cara y genitales.
2) Valor pronóstico de respuesta al tratamiento de:
-Presencia de Koebner + ó –
-Duración de la enfermedad < ó > de 5 años.
-Presencia de anticuerpos antitiroglobulina, antitiroideos y anticélula parietal gástrica.
4) Diferencias del área de repigmentación entre las lesiones de vitíligo del grupo tratado y de los grupo control.
5) Tolerabilidad y seguridad del tacalcitol durante los 120 días de tratamiento
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 Information not present in EudraCT
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 No
E.8.1.3Single blind No
E.8.1.4Double blind Yes
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 Yes
E.8.2.3Other No
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 Information not present in EudraCT
E.8.7Trial has a data monitoring committee Information not present in EudraCT
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 years
E.8.9.1In the Member State concerned months4
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 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) No
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 Information not present in EudraCT
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
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 state76
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 Decision2005-02-04
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2004-05-27
P. End of Trial
P.End of Trial StatusOngoing

Sponsor e collaboratori

Condizioni mediche

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