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    Summary
    EudraCT Number:2004-002673-22
    Sponsor's Protocol Code Number:309189
    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:2006-01-25
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2004-002673-22
    A.3Full title of the trial
    Estudio doble ciego, controlado con placebo, aleatorizado, multicéntrico, paralelo, para comparar la eficacia y la seguridad de Adventan crema dos veces por semana con Advabase crema, durante una fase de mantenimiento de 16 semanas tras el tratamiento con éxito de la Dermatitis Atópica con Adventan crema
    A.3.2Name or abbreviated title of the trial where available
    Advantan maintenance study
    A.4.1Sponsor's protocol code number309189
    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 SponsorSchering AG
    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 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.2.1.1.1Trade name Advantan Cream 0,1 %
    D.2.1.1.2Name of the Marketing Authorisation holderSchering Deutschland GmbH
    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 nameAdvantan Creme
    D.3.2Product code SH C 440 F
    D.3.4Pharmaceutical form Cream
    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 INNMethylprednisolonaceponat
    D.3.9.2Current sponsor codeSH C 440 F
    D.3.9.3Other descriptive nameAdvantan Creme
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    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) 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 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
    Atopic Dermatitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.1
    E.1.2Level PT
    E.1.2Classification code 10012438
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Long term management of atopic dermatitis
    E.2.2Secondary objectives of the trial
    Efficacy and safety of Advantan Creme
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    To be randomized, each patient must fulfill all of the inclusion criteria listed below.
    1. Fully informed written consent of the legal representative and assent of the patient
    2. Acute flare of atopic dermatitis according to the Investigator’s Global Assessment
    (IGA >= 4) ‘Severe’ or ‘Very Severe’
    3. History of moderate to severe form of atopic dermatitis for at least two years
    4. Age of 12 years at Screening or older
    5. Wash out periods to be observed before Baseline:
    - At least 4 weeks have passed since any use of systemic therapy for atopic dermatitis (AD), e. g., systemic corticosteroids (including inhaled or intranasal > 1mg/d), cyclosporine A, azathioprine, mycophenolate mofetil, or phototherapy
    - At least 4 weeks have passed since any use of systemic AD therapy, e. g., systemic corticosteroids (including inhaled or intranasal > 1mg/d), cyclosporine A, azathioprine, mycophenolate mofetil, or phototherapy
    - At last 4 weeks have passed since any vaccination
    - At least 4 weeks have passed since local AD therapy using Protopic or Elidel
    - At least 2 weeks (4 weeks for Terfenadine) have passed since antihistaminic therapy, unless taken regularly during the previous year
    - At least 1 week has passed since local AD therapy using corticosteroids
    6. At least 4 weeks have passed since participation in an investigational drug study
    7. Willingness to follow all study procedures – including the self-responsible part of to decide what is considered a relapse
    E.4Principal exclusion criteria
    For scientific and safety reasons and in accordance with the respective product information, patients exhibiting any of the criteria below are to be excluded from the Study:
    1. Pregnancy, breast feeding
    2. Any conditions that could interfere with any evaluation in the study
    3. Indication for systemic AD therapy
    4. Known sensitivity to Advantan, Advabase and / or to any content of the respective formulations
    5. Known immune, hepatic, or renal insufficiency
    6. Acute herpes simplex or mollusca contagiosa infection
    7. Acute and severe impetigo contagiosa. A slight superinfection of eczema is no exclusion criterion
    8. Severe other viral, bacterial, or fungal skin infection (chicken pox, prominent tinea corporis)
    9. Acute infestations (e.g. head lice, scabies)
    10. Any conditions that compromise the patient's ability to understand the patient information, to give informed consent/assent, to comply with the trial protocol, or to complete the study
    11. Patient is considered a dependent person, e.g., a relative / family member and / or is a member of the investigator’s staff
    12. Forfeited freedom by administrative or legal award or adult subject to administrative guardianship
    E.5 End points
    E.5.1Primary end point(s)
    Time to relapse is the primary end point. It is defined as the number of days from End of AP (last continuous Advantan dose) until the disease relapses and the patient requests more intense treatment. The relevant date to calculate time to relapse is the date when the patient seeks treatment exceeding the maintenance regimen, not necessarily the installation of the new treatment. The patient should return to a visit to the investigator to raise this request, and the date will be recorded. Time to relapse will be calculated from the calendar dates by central study management, and not at the trial site. MP stops with this date, and the end of study medication visit is to be performed.
    If the patient concludes the scheduled 16 weeks MP without relapse, this fact will be recorded instead of a time to relapse.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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.8.5The trial involves multiple Member States Yes
    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
    Last patient last visit
    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 days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-01-25. Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Because of minor age, patients are not legally acceptable consenters
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 250
    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)
    Normal treatment of atopic dermatitis
    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 Decision2005-04-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-03-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-06-13
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