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    Summary
    EudraCT Number:2011-004953-17
    Sponsor's Protocol Code Number:TUD-OCTpro-053
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-09
    Trial results View 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 ConcernedGermany - BfArM
    A.2EudraCT number2011-004953-17
    A.3Full title of the trial
    Measurement of epidermal and dermal thickness under therapy with Pimecrolimus 1 % Creme (Elidel® 1 % Creme), Hydrocortisonacetat 1 % Creme (Hydrogalen® Creme), Betamethasonvalerat 0,1 % Creme (Betagalen® Creme), Methylprednisolonaceponat 0,1 % Creme (Advantan® Creme), Dermatop® Basecreme and without therapy by optical coherencetomography (OCT) and 20-MHZ-ultrasound.
    Bestimmung epidermalen und dermalen Hautdicke unter Behandlung mit Pimecrolimus 1 % Creme (Elidel® 1 % Creme), Hydrocortisonacetat 1 % Creme (Hydrogalen® Creme), Betamethasonvalerat 0,1 % Creme (Betagalen® Creme), Methylprednisolonaceponat 0,1 % Creme (Advantan® Creme), Dermatop® Basiscreme und ohne Behandlung mittels Optischer Kohärenztomographie (OCT) und 20-MHz-Ultraschall.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Measurement of coutaneous thickness under therapy with glucocorticoids of different strengh, calcineurininhibitor and basecreme, using different technical advices like ultrasound and optical coherencetomography.
    Bestimmung der Veränderung der Hautdicke unter Behandlung mit einem Calcineurininhibitor, Glukokortikoiden der Stärke I und III, sowie einer Basiscreme mittels unterschiedlicher Messmethoden.
    A.3.2Name or abbreviated title of the trial where available
    OCT-proaktiv-Studie
    A.4.1Sponsor's protocol code numberTUD-OCTpro-053
    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 SponsorTechnical university Dresden
    B.1.3.4CountryGermany
    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 supportTechnical university Dresden
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTechnical University Dresden
    B.5.2Functional name of contact pointDr. R. Aschoff
    B.5.3 Address:
    B.5.3.1Street AddressFetscherstr. 74
    B.5.3.2Town/ cityDresden
    B.5.3.3Post code01307
    B.5.3.4CountryGermany
    B.5.4Telephone number+49351458-2007
    B.5.5Fax number+49351458-5739
    B.5.6E-mailRoland.Aschoff@uniklinikum-dresden.de
    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 Elidel® 1 % Creme
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameElidel 1% Creme
    D.3.2Product code D11AX15
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    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 INNElidel
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1 to %
    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 Hydrogalen® Creme
    D.2.1.1.2Name of the Marketing Authorisation holderGALENpharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameHydrogalen Creme
    D.3.2Product code D07AA02
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 50-23-7
    D.3.9.3Other descriptive nameHYDROCORTISONE
    D.3.9.4EV Substance CodeSUB08065MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1 to %
    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: 3
    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 Betagalen® Creme
    D.2.1.1.2Name of the Marketing Authorisation holderGALENpharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameBetaGalen Creme
    D.3.2Product code D07AC01
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 2152-44-5
    D.3.9.3Other descriptive nameBETAMETHASONE VALERATE
    D.3.9.4EV Substance CodeSUB00786MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1 to %
    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: 4
    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 Advantan® Creme
    D.2.1.1.2Name of the Marketing Authorisation holderIntendis GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameAdvantan
    D.3.2Product code D07AC14
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 86401-95-8
    D.3.9.3Other descriptive nameMETHYLPREDNISOLONE ACEPONATE
    D.3.9.4EV Substance CodeSUB08873MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1 to %
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCream
    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
    - age 18-40 years
    - health volunteers
    - normal dermis
    - written accordance of the test person
    - Alter 18 Jahre bis 40 Jahre,
    - hautgesunde Probanden,
    - normale alterstypische Haut,
    - Hauttyp I-III nach Fitzpatrick,
    - schriftliches Einverständnis des Probanden
    E.1.1.1Medical condition in easily understood language
    healthy volunteers, aged 18 to 40
    Gesunde Proband im Alter von 18 bis 40 Jahren, welche gesunde Haut besitzen.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Equipment and Supplies [E07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10071104
    E.1.2Term Glucocorticoid therapy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10068183
    E.1.2Term Calcineurin inhibitor induced pain syndrome
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    If there is no dermal and epidermal thinning under therapy with the active components twice weekly for 12 weeks, this OCT-proactive trial is a safety-contribution for the actual therapy-plan of patiens with atopic dermatitis.
    Sollte in der klinischen Prüfung nachgewiesen werden, dass bei zweimal wöchentlicher Anwendung und über einen Anwendungszeitraum von 12 Wochen keine Epidermisverdünnung auftritt, so würde die klinische Prüfung die Sicherheit dieses Therapieschemas unterstützen. Diese OCT-proaktiv-Studie stellt einen Beitrag zur Sicherheit des gegenwärtig empfohlenen Behandlungsschemas bei atopischem Ekzem dar.
    E.2.2Secondary objectives of the trial
    -measurement of cutaneous thickness by usind 20-MHZ-ultrasound,
    - measurement of cutaneous atrophy and teleangiectasies by using dermaphot®
    - measurement of cutaneous water content by usind corneometer
    - measurement of epidermal water loss from the cutaneous tissue by using Tewameter
    -Bestimmung der Dermisdicke mittels 20-MHz-Ultraschall,
    -Bestimmung der Hautatrophie und der Teleangiektasien mittels Dermaphot®
    -Bestimmung der Hautfeuchtigkeit mittels Corneometer,
    -Bestimmung der Hautfeuchtigkeitsabgabe mittels Tewameter
    This trial contribue to the safety of this therapy regimes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - age 18-40 years
    - health volunteers
    - normal dermis
    - written accordance of the test person
    - Alter 18 Jahre bis 40 Jahre,
    - hautgesunde Probanden,
    - normale alterstypische Haut,
    - Hauttyp I-III nach Fitzpatrick,
    - schriftliches Einverständnis des Probanden
    E.4Principal exclusion criteria
    - pregnant or nursing woman,
    - missing contraception,
    - external or systemic therapy in the last 6 months with special drugs (Retinoids, Glucocorticoisteroids, Calcineurininhibitors,..)
    - disease of the epidermis (atopic dermatitis, psoriasis, erythrodermie,...), skin disease who makes topical application of cremes impossible
    - intensive UV-exposition or UV-therapy within the last 4 weeks or in trial,
    - simultaneous participance in other clinical studies and participation in a second trial within the last 30 days
    -hypersensitivity against Elidel®, Hydrogalen® Creme, Betagalen® Creme, Advantan® Creme, or Dermatop® Basecreme,
    - disease with anticipate a therapy with Elidel®, Betagalen® Creme, Ecural® Fettcreme, Hydrogalen® Creme, Advantan® Creme or Dermatop® Basecreme,
    - use of immunsuppressive drugs, or severe systemic disease,
    - non-compliance,
    -vaccination within the last 14 days
    -Schwangerschaft oder Stillzeit,
    -Fehlende oder unsichere Kontrazeption für Probanden im gebärfähigen Alter,
    -Frauen im gebärfähigen Alter, außer Frauen, die die folgenden Kriterien erfüllen:
    ▪ post-menopausal (12 Monate natürliche Amenorrhoe),
    ▪ postoperativ (6 Wochen nach beidseitiger Ovarektomie mit oder ohne Hysterektomie),
    ▪ regelmäßige und korrekte Anwendung einer Verhütungsmethode mit Fehlerquo-te <1 % pro Jahr (z.B. Implantate, Depotspritzen, orale Kontrazeptiva, Intrauterine Device - IUD),
    ▪ sexuelle Enthaltsamkeit,
    ▪ Vasektomie des Partners.
    - Frauen in der Stillzeit,
    - Äußerliche oder systemische Behandlung innerhalb der letzten 6 Monate vor Beginn der Studie mit Medikamenten (z. B. Retinoide, Glukokortikosteroide, Calcineurininhibitoren, Teer), die vermutlich oder bekannterweise einen Effekt auf Hautdicke oder Bildung von Teleangiektasien haben,
    - Intensive natürliche oder künstliche UV-Lichttherapie innerhalb der letzten 4 Wochen vor Beginn der Studie und / oder während der Studie,
    - Gleichzeitige Teilnahme an anderen Studien,
    - Teilnahme an anderen klinischen Studien innerhalb der letzten 30 Tage vor Beginn der Studie,
    -Überempfindlichkeit gegen einen Bestandteil von Elidel®, Hydrogalen® Creme, Betagalen® Creme, Advantan® Creme, oder Dermatop® Basiscreme,
    - Mangelnde oder zweifelhafte Kooperationsfähigkeit oder –bereitschaft,
    - Anderweitige Gründe, welche gemäß Prüfarzt eine Teilnahme an der Studie ausschließen,
    - Impfungen sollten vor Behandlungsbeginn durchgeführt werden oder 14 Tage, bei Lebendimpfstoff 28 Tage nach Absetzen einer Therapie mit topischen Calcineurininhibitoren.
    E.5 End points
    E.5.1Primary end point(s)
    Measurement of epidermal and dermal thickness under therapy with Pimecrolimus 1 % Creme (Elidel® 1 % Creme), Hydrocortisonacetat 1 % Creme (Hydrogalen® Creme), Betamethasonvalerat 0,1 % Creme (Betagalen® Creme), Methylprednisolonaceponat 0,1 % Creme (Advantan® Creme), Dermatop® Basecreme and without therapy by optical coherencetomography (OCT) and 20-MHZ-ultrasound.
    Bestimmung epidermalen und dermalen Hautdicke unter Behandlung mit Pimecrolimus 1 % Creme (Elidel® 1 % Creme), Hydrocortisonacetat 1 % Creme (Hydrogalen® Creme), Betamethasonvalerat 0,1 % Creme (Betagalen® Creme), Methylprednisolonaceponat 0,1 % Creme (Advantan® Creme), Dermatop® Basiscreme und ohne Behandlung mittels Optischer Kohärenztomographie (OCT) und 20-MHz-Ultraschall.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The study lasts 9 months. first patient, first visit: november 2011, last patient, last visit: july 2012. Duration per volunteer: 12 weeks exculsive 4 weeks observationtime. 12 weeks of treatement and 4 weeks observation without treatement
    Die Studiendauer beträgt 9 Monate. Der Beginn der Studie ist für November 2011 geplant. Voraussichtlich wird im Juli 2012 die Abschlussuntersuchung des zuletzt aufgenommenen Probanden stattfinden. Die Studiendauer pro Proband beträgt 12 Wochen exklusive 4 Wochen Nachbeobachtungszeit.
    E.5.2Secondary end point(s)
    -measurement of cutaneous thickness by using 20-MHZ-ultrasound,
    - measurement of cutaneous atrophy and teleangieectasies by using dermaphot®
    - measurement of cutaneous humidity by usind corneometer
    - measurement of epidermal water content of the cutaneous tissue by using Tewameter
    -Bestimmung der Dermisdicke mittels 20-MHz-Ultraschall,
    -Bestimmung der Hautatrophie und der Teleangiektasien mittels Dermaphot, ®
    -Bestimmung der Hautfeuchtigkeit mittels Corneometer,
    -Bestimmung der Hautfeuchtigkeitsabgabe mittels Tewameter
    E.5.2.1Timepoint(s) of evaluation of this end point
    Primary Endpoint: EOS
    Secondary Endpoint: EOS
    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 No
    E.6.4Safety Yes
    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.7.1.3.1Other 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 Yes
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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
    NA
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial 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: 30
    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 Yes
    F.3.2Patients No
    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 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)
    Nach 12-wöchiger Therapie findet ein 4-wöchiger Beobachtungszeitraum statt.
    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 Decision2012-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-01
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