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    Summary
    EudraCT Number:2011-006275-20
    Sponsor's Protocol Code Number:LP0074-33
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-06-26
    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 number2011-006275-20
    A.3Full title of the trial
    A phase II exploratory study evaluating the efficacy of topical cromoglicate solution(20mg/ml) compared to topical solution vehicle in the treatment of mastocytosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study evaluating the efficacy of topical cromoglicate solution compared to placeboin the treatment of mastocytosis
    A.3.2Name or abbreviated title of the trial where available
    Cromoglicate in Mastocytosis
    A.4.1Sponsor's protocol code numberLP0074-33
    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 SponsorLEO Pharma A/S
    B.1.3.4CountryDenmark
    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 supportLEO Pharma A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLEO Pharma A/S
    B.5.2Functional name of contact pointInternational Clinical Development
    B.5.3 Address:
    B.5.3.1Street AddressIndustriparken 55
    B.5.3.2Town/ cityBallerup
    B.5.3.3Post code2750
    B.5.3.4CountryDenmark
    B.5.4Telephone number004572262067
    B.5.5Fax number004572263321
    B.5.6E-mailcasper.clemmensen@leo-pharma.com
    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 Como-Stulln UD
    D.2.1.1.2Name of the Marketing Authorisation holderPharma Stulln 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 nameCromo-Stulln UD
    D.3.4Pharmaceutical form Cutaneous solution
    D.3.4.1Specific paediatric formulation No
    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 INNCROMOGLICATE SODIUM
    D.3.9.1CAS number 15826-37-6
    D.3.9.2Current sponsor codeLP0075
    D.3.9.4EV Substance CodeSUB01492MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 placeboCutaneous solution
    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
    mastocytosis
    Juckreiz bei Patienten mit Mastocytose
    E.1.1.1Medical condition in easily understood language
    mastocytosis
    Mastocytose
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10012812
    E.1.2Term Diffuse cutaneous mastocytosis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10056452
    E.1.2Term Indolent systemic mastocytosis
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the clinical efficacy of treatment with topical cromoglycate solution in patients with mastocytosis
    E.2.2Secondary objectives of the trial
    To investigate the safety of treatment with topical cromoglycate solution in patients with mastocytosis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent has been obtained
    2. Chronic stable symptomatic maculopapulous cutaneous mastocytosis or indolent systemic mastocy-tosis with skin involvement and a positive Darier’s Sign
    3. Age between 18 and 70 years
    4. Either sex
    5. Any race or ethnicity
    6. Attending hospital outpatient clinic or the private practice of a dermatologist
    1. Unterschriebene Einverständniserklärung wurde eingeholt
    2. Chronisch stabile, symptomatische, makulopapulöse kutane Mastozytose oder indolente systemische Mastozytose mit Hautbeteiligung und positiven Da-rier-Zeichen
    3. Alter zwischen 18 und 70 Jahre
    4. Beiderlei Geschlechts
    5. Jede Rasse oder ethnische Zugehörigkeit
    6. Behandlung in einer Krankenhausambulanz oder privaten Praxis eines Dermatologen

    E.4Principal exclusion criteria
    1. The presence of autoimmune and infectious disease including aggressive systemic mastocytosis
    2. Medical history or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or is-chemia
    3. Medical history or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy, hyper/hypokalemia
    4. Evidence of severe renal dysfunction (creatinine > 1,5 times upper reference value)
    5. Evidence of significant hepatic disease (liver enzymes > 2 times upper reference value)
    6. Presence of active cancer which requires chemothera-py or radiation therapy
    7. Commitment to an institution in terms of § 40 Abs. 1 S. 3 Nr. 4 AMG
    8. Intake of antihistamines or leukotriene antagonists within 7 days prior to the beginning of the study
    9. Intake of oral corticosteroids within 14 days prior to randomisation
    10. Use of depot corticosteroids or chronic systemic corticosteroids within 21 days prior to randomisation
    11. Radiation therapy of target areas including UV therapy within 4 weeks prior to randomisation
    12. Confounding other dermatological diseases or conditions that can affect the symptoms of the target areas
    13. Known or suspected hypersensitivity to component(s) of investigational products.
    14. Current participation in any other interventional clinical trial.
    15. Subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within the last 4 weeks or 5 half-lives (whichever is longer) prior to randomisation
    16. Previously randomised in this clinical trial
    17. In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state).
    18. Females who are pregnant, of child-bearing potential and wishing to become pregnant during the trial or are breast feeding.
    19. Females of child-bearing potential with positive pregnancy test at visit 1.
    20. Subjects (or their partner) not using an adequate method of contraception (according to national re-quirements, as applicable)
    1. Das Vorhandensein von Autoimmun- und einer Infektionserkrankungen einschließlich einer aggressiven systemischen Mastozytose
    2. Epilepsie, signifikante neurologische Erkrankungen, cerebrovasculäre Attacken oder Ischämien jeweils bestehend oder in der Anamnese
    3. Myokardinfarkt oder kardiale Arrythmien, die medikamentöse Behandlung erfordern, Hyper-/Hypokalämie jeweils bestehend oder in der Anamnese
    4. Nachgewiesene schwere renale Dysfunktionen (Kreatinin > 1,5 mal über dem höherem Referenzwert)
    5. Nachgewiesene schwere Leberfunktionsstörungen (Leberenzyme > 2 mal über dem höherem Referenzwert)
    6. Bestehende aktive Krebserkrankung, die Chemotherapie oder Bestrahlung erfordert
    7. Unterbringung in einer Einrichtung gemäß § 40 Abs. 1 S. 3 Nr. 4 AMG
    8. Einnahme von Antihistaminika oder Leukotrien-Antagonisten innerhalb von 7 Tagen vor Studienbeginn
    9. Einnahme von oralen Kortikosteroiden innerhalb von 14 Tagen vor Randomisierung
    10. Anwendung von Depot-Kortikosteroiden oder chronisch systemischen Kortikosteroiden innerhalb von 21 Tagen vor Randomisierung
    11. Therapeutische Bestrahlung der Zielbereiche einschließlich UV-Therapie innerhalb von 4 Wochen vor Randomisierung
    12. Andere dermatologische Erkrankungen oder Bedingungen die zu Verwechslung oder Beeinflussung der Symptome an der Zielläsion führen können
    13. Bekannte oder vermutete Überempfindlichkeiten auf Bestandteile der Studienmedikation
    14. Gegenwärtige Teilnahme an einer anderen klinischen Studie

    15. Personen, die mit einer anderen nicht zugelassen Substanz behandelt wurden (z.B. ein Wirkstoff, der noch nicht für die klinische Anwendung durch Zulassung verfügbar gemacht wurde) innerhalb der letzten 4 Wochen oder 5 Halbwertszeiten (je nachdem was länger ist) vor Randomisierung
    16. Personen, die bereits schon früher einmal in dieser Studie randomisiert wurden
    17. Personen, die nach Einschätzung des Prüfarztes den Anforderungen des Studienprotokolls voraussichtlich nicht nachkommen werden (z.B. Alkoholismus, Drogenabhängigkeit oder psychischer Zustand)
    18. Frauen, die schwanger sind oder im gebärfähigen Alter und wünschen während der Studie schwanger zu werden oder die stillen.
    19. Frauen im gebärfähigen Alter mit einem positiven Schwangerschaftstest zu Visit 1.
    20. Personen (oder deren Partner) die keine adäquate Verhütungsmethode anwenden (definiert als Pearl Index < 1)
    E.5 End points
    E.5.1Primary end point(s)
    Clinical evaluation of treatment response comparing cromoglicate to vehicle. Evaluation of mechanically induced changes of lesions (Darier’s Sign) by the investigator using a composite score (Maximum = 9 points) evaluating wheal, erythema and itching each on a 4 point scale (0= no, 1=mild, 2= moderate, 3= severe) and VAS.
    Klinische Beurteilung des Ansprechens der Behandlung mit Cromoglicat im Vergleich zu Vehikel. Beurteilung der mechanisch induzierten Änderungen der Läsionen (Darier’s Zeichen) durch den Prüfarzt indem eine zusammengesetzte Benotung (Maximum = 9 Punkte) verwendet wird, die Quaddeln, Erythem und Juckreiz jeweils auf einer 4-Punkte-Skala (0= keine, 1=mild, 2= mäßig, 3= schwer) auswertet und VAS (Visuelle Analog Skala).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation on Visit 2 after 14 days on treatment
    Evaluierung an Visit 2 nach 14-tägiger Behandlungsdauer
    E.5.2Secondary end point(s)
    Change from baseline of mechanically induced wheal and flare response comparing cromoglycate to placebo and active. Evaluation by volumetric and thermographic analyses
    Gene expression
    Immunohistochemistry
    Änderungen zu Baseline bezogen auf Quaddelbildung und Brennen im Vergleich von Cromoglicat zu Vehikel.
    Die Auswertung erfolgt durch volumetrische und thermografische Analysen.
    Gen-Expression
    Immunohistochemie
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation on Visit 2 after 14 days on treatment
    Evaluierung an Visit 2 nach 14-tägiger Behandlungsdauer
    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 No
    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) 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 No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    left/right comparison study, each subject will use blinded actice and placebo
    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.8.2.4Number of treatment arms in the trial1
    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
    LVLS
    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 months5
    E.8.9.1In the Member State concerned 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: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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)
    expected normal treatment of that condition
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-08-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-03-05
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