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    Summary
    EudraCT Number:2004-001273-26
    Sponsor's Protocol Code Number:CASM981CES02
    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:2004-09-16
    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 number2004-001273-26
    A.3Full title of the trial
    A 3 weeks study randomized, multicenter, double blind, vehicle controlled , parallel-group to evaluate the efficacy and safety of Pimecrolimus cream 1% in children between 2 – 11 years with mild to moderate atopic dermatitis
    A.3.2Name or abbreviated title of the trial where available
    SPEED
    A.4.1Sponsor's protocol code numberCASM981CES02
    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 SponsorNOVARTIS FARMACEUTICA, S.A
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 Elidel
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Farmaceutica S.A.
    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 nameElidel
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpimecrolimus
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    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 placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mild to moderate Atopic Dermatitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level LLT
    E.1.2Classification code 10003641
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that pimecrolimus cream 1 % is superior to vehicle cream in time of improvement of pruritus, administered twice a day to both groups on the areas affected by AD, in patients between 2 – 11 years of age with mild-to-moderate AD.
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy (IGA and EASI improvement) of Pimecrolimus cream 1 % administered b.i.d. over vehicle cream 1 %.
    - To evaluate the improvement of the sleep (when it is affected in the baseline) with Pimecrolimus cream 1 % treatment administered b.i.d. in regards of ASM981 vehicle cream.
    - To determine safety and tolerability of Pimecrolimus cream 1 % treatment.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    - Male or female
    - Age: between 2 – 11 years
    - Outpatients with diagnosis atopic dermatitis using diagnostic criteria of Williams and cols.
    - AD affecting ≥ 5% of Total Body Surface Area (estimated using the patient’s palm of the hand as approximately 1% TBSA)
    - Baseline Investigator’s Global Assessment score of 2 (mild) or 3 (moderate)
    - Baseline visit pruritus associated to atopic dermatitis
    - Patients or patient’s legal guardian who has been informed of the study procedures and has signed the informed consent form approved for the study prior to starting any study related procedures, including washout (in case that it would be necessary).
    E.4Principal exclusion criteria
    - Who are using a topical medication (prescription or OTC medications) for pruritus relief within 7 days of study start
    - Who are taking any systemic (oral/IM/IV) medication known to have a sedating side affect or known to affect pruritus such as tranquilizers, hypnotic agents, anxiolytics (including oral doxepin), tricyclic antidepressants, corticosteriods or antihistamines (sedating or non-sedating) within 1 week prior to first application of study medication.
    - Phototherapy (e.g., UVB, PUVA) or systemic therapy (e.g., immunosuppressants, corticosteroids, cytostatics) known or suspected to have an effect on atopic dermatitis within 1 month prior to first application of study medication.
    - Topical tacrolimus ointment (Protopic) or ASM981 (Pimecrolimus) cream within 4 weeks prior to first application of study medication regardless of whether the medication was given as an investigational drug.
    - Topical therapy (e.g. tar, topical corticosteroid) known or suspected to have a therapeutic effect on atopic dermatitis within 7 days prior to first application of study medication
    - Systemic antibiotics within 1 week prior to first application of study medication
    - Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or a history of malignant disease
    - Concurrent skin disease (e.g., acne) of such severity in the study area that it could interfere with the evaluation
    - Atopic dermatitis triggered by a known irritant/allergen that is unavoidable
    - Active bacterial, viral or fungal infections that require treatment with a prohibited medication
    - Active infection at the site(s) of treatment
    - Atopic dermatitis that, in the investigator’s opinion, requires systemic therapy and will not be controlled with study medication
    - Investigational drugs within 8 weeks prior to first application of study medication or use of other investigational drugs during the course of this study
    - Known hypersensitivity to any ingredient of ASM981 cream 1% (see the Investigators Brochure)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is to demonstrate that the therapeutic efficacy of Pimecrolimus cream 1 % administered b.i.d. is superior to ASM981 vehicle cream administered b.i.d. evaluating the time to pruritus improvement
    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 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 No
    E.6.13Others Information not present in EudraCT
    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 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 months9
    E.8.9.1In the Member State concerned days
    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) Yes
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children aged 2-11 years needs legal representative authorization
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state117
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 117
    F.4.2.2In the whole clinical trial 117
    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 Decision2004-08-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-05-19
    P. End of Trial
    P.End of Trial StatusCompleted
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