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    The EU Clinical Trials Register currently displays   41232   clinical trials with a EudraCT protocol, of which   6757   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2011-004094-93
    Sponsor's Protocol Code Number:PAFCUTIII
    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:2012-01-27
    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 number2011-004094-93
    A.3Full title of the trial
    Double-blind, three-way cross-over, placebo controlled study to assess the efficacy, safety and mechanisms of treatment with rupatadine 20 and 40mg in cold contact urticaria (CCU)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of rupatadine in cold contact urticaria
    A.3.2Name or abbreviated title of the trial where available
    PAFCUTIII
    A.4.1Sponsor's protocol code numberPAFCUTIII
    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 SponsorAllergie-Centrum Charité
    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 supportJ. Uriach Cia., S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité-Universitätsmedizin Berlin
    B.5.2Functional name of contact pointAllergie-Centrum Charité
    B.5.3 Address:
    B.5.3.1Street AddressCharitéplatz 1
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code10117
    B.5.3.4CountryGermany
    B.5.4Telephone number+4930518 043
    B.5.5Fax number+4930518 972
    B.5.6E-mailmarcus.maurer@charite.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 Rupafin
    D.2.1.1.2Name of the Marketing Authorisation holderJ. Uriach Cia., S.A.
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRupatadine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    D.3.11.13.1Other medicinal product typeAntihistamine
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cold contact urticaria
    E.1.1.1Medical condition in easily understood language
    Cutaneous condition characterized by wheals, and occurs in rainy, windy weather, and after contact with cold objects
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10009869
    E.1.2Term Cold urticaria
    E.1.2System Organ Class 10040785 - Skin and subcutaneous 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
    To assess the effects of rupatadine 20 mg and 40 mg on symptom
    development during the induction of skin lesions in CCU patients
    challenged with defined temperatures using Temptest® 3.0
    E.2.2Secondary objectives of the trial
    To assess the effects of rupatadine on mast cell mediator release in blood during the induction of skin lesions in CCU patients challenged with cold water bath provocation with defined temperatures. Mediator measurements will include histamine and other mast cell-derived inflammation markers (e.g. PAF/LysoPAF, PGD2)
    To assess the effect of rupatadine on mast cell activation in the skin of CCU patients
    To assess the safety and tolerability of rupatadine
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Informed consent signed and dated.
    • Reliable method of contraception for women of childbearing potential during the study and 3 months thereafter.
    • Outpatients with CCU for more than 6 weeks confirmed by
    positive response with wheal and itch on Temptest®.
    • Age 18 and above years.
    • No participation in other clinical trials 1 month before and after
    participation in this study.
    E.4Principal exclusion criteria
    • Subjects who are inmates of psychiatric wards, prisons, or other state institutions. Existing or planned placement in an institution after ruling according to § 40 passage 1, number 4 AMG (Arzneimittelgesetz).
    • The presence of permanent severe diseases, especially those affecting the immune system, except urticaria and cold urticaria.
    • The presence of permanent gastrointestinal condition which may
    influence the oral therapy (chronic diarrhoea diseases, congenital
    malformations or surgical mutilations of gastrointestinal tract).
    • History or presence of epilepsy, significant neurological disorders,
    cerebrovascular attacks or ischemia.
    • History or presence of myocardial infarction or cardiac arrhythmia
    which requires drug therapy.
    • ECG alterations of repolarisation (QTc prolongations > 450ms).
    • Blood pressure >180/100 mmHg and/or heart rate >100/min.
    • Evidence of significant hepatic or renal disease (GOT and/or GPT 3 times above the upper reference value, serum creatinine 1.5 times above the upper reference value).
    • History of hypersensitivity or allergic reaction to rupatadine or any other antihistamine compounds.
    • Presence of active cancer which requires chemotherapy or radiation therapy.
    • Presence of lactose and galactose intolerance or glucose-galactose malabsorption.
    • Simultaneous chronic spontaneous or physical urticaria that could interfere CCU clinical assessment.
    • Intake of antihistamines or antileukotrienes within 7 days before
    beginning of the study.
    • Intake of oral or depot corticosteroids within 14 days prior to
    screening visit.
    • Use of systemic immunosupressants/immunomodulators like
    cyclosporine A, dapsone, methotrexate, mycophenolate, chloroquine, and comparable drugs within 28 days prior to screening visit.
    • Use of ketoconazole, erythromycin or potential inhibitors of the
    isoenzyme CYP3A4 of the cytochrome P450.
    • Currently abusing drugs or alcohol.
    • Unwilling or unable to comply with the protocol.
    • Pregnancy or breast-feeding.
    E.5 End points
    E.5.1Primary end point(s)
    - Change in critical stimulation time thresholds (CSTT) and critical
    temperature thresholds (CTT) after treatment with different dosages of rupatadine (20 mg and 40 mg) measured by Temptest® 3.0
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 2, Visit 3, Visit 4, Visit 5
    E.5.2Secondary end point(s)
    - Change in mast cell mediator release, including histamine,
    PAF/LysoPAF and PGD2 after treatment with rupatadine (20 and 40 mg) compared to placebo
    - Change in mast cell activation (measured by intracutaneous codeine,histamine, PAF and saline injection)
    - Safety and tolerability: This includes physical examination, routine safety laboratory assessments, clinical observation, vital signs and adverse event reporting
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 3, Visit 4, Visit 5
    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 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 Yes
    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.8.2.4Number of treatment arms in the trial6
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 Yes
    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 months7
    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 months7
    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: 24
    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 Yes
    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 2012-01-27. Yes
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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)
    All patients will be offered a follow up visit at the out-patients clinic of the corresponding study place to receive best medical care after having participated in the study.
    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 Decision2012-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-02
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