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    The EU Clinical Trials Register currently displays   43977   clinical trials with a EudraCT protocol, of which   7312   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).

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    Summary
    EudraCT Number:2004-002823-42
    Sponsor's Protocol Code Number:A00401
    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:2005-03-22
    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 number2004-002823-42
    A.3Full title of the trial
    A multicentre, double-blind, parallel, randomized, placebo-controlled study :
    Evaluation of the efficacy and safety of Levocetirizine 5 mg and Desloratadine 5 mg
    administered orally as capsules once daily, in the morning, over 2 weeks in patients
    suffering from Seasonal Allergic Rhinitis (SAR) due to grass pollen
    A.4.1Sponsor's protocol code numberA00401
    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 SponsorUCB S.A. Pharma Sector
    B.1.3.4CountryBelgium
    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.2.5The 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 namelevocetirizine
    D.3.2Product code ucb 28556
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNLevocetirizine Dihydrochloride
    D.3.9.1CAS number 130018-87-0
    D.3.9.2Current sponsor codeucb 28556
    D.3.9.3Other descriptive name[2-[4-[(R)-p-chloro-α -phenylbenzyl]-1-piperazinyl]
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.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 Information not present in EudraCT
    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 namedesloratadine
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNDesloratadine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 placeboCapsule*
    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
    Allergic Rhinitis (AR)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.1
    E.1.2Level LLT
    E.1.2Classification code 10001723
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare clinical efficacy of Levocetirizine 5 mg and Desloratadine 5 mg as
    measured by the mean change from the baseline of Total 4 Symptom Score (T4SS)
    over two weeks of treatment. T4SS: sum of the individual symptom scores for
    sneezing, rhinorrhea, nasal pruritus, ocular pruritus, evaluated on a 4-point scale
    retrospectively over the past 24 hours.
    E.2.2Secondary objectives of the trial
    • To compare clinical efficacy of Levocetirizine 5 mg and Desloratadine 5 mg as
    measured by the mean change from the baseline of T4SS over the first week of
    treatment.
    •To compare clinical efficacy of Levocetirizine 5 mg and Desloratadine 5 mg as
    measured by the mean change from the baseline of the 5 individual symptom scores
    for sneezing, rhinorrhea, nasal pruritus, ocular pruritus and nasal congestion
    evaluated on a 4-point scale retrospectively over the past 24 hours, over the first
    week and over two weeks of treatment.
    •To compare clinical efficacy of Levocetirizine 5 mg and Desloratadine 5 mg vs.
    placebo as measured by the mean change from the baseline of T4SS and the 5
    individual symptom scores for sneezing, rhinorrhea, nasal pruritus, ocular pruritus
    and nasal congestion evaluated on a 4-point scale retrospectively over the past 24
    hours, over the first week and over two weeks of treatment.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    To enter the study, subjects should meet the following criteria:
    At Visit 1
    • Be informed of the nature and aims of the study (refer to ICF) and be their written
    informed consent to participate in this study
    •Male or female out subject aged ≥18 years
    •Female subjects of childbearing potential must agree not to become pregnant during thestudy. Female subjects are considered of non-childbearing potential before menarche,or at least two years after menopause, or if they had a total hysterectomy or a bilateralovariectomy or a congenital sterility. When sexually active, females of childbearingpotential must be using either oral contraceptives, contraceptive trans-dermal device,contraceptive injections for at least two months; have had a bilateral tubal ligation; havemonogamous relationship with vasectomized partner or agree to use intra-uterinedevice, diaphragm with spermicide, or male condom with spermicide.
    •Be able to understand the information given and the text of the informed consent, tocomplete the daily record card (See Appendix 18.1), as well as to discuss with the
    Investigator.
    •At least 2-year history of seasonal allergic rhinitis that became symptomatic during theannual grass pollen season.
    •A skin test or a RAST (Radio Allergo Sorbent Test) for grass pollens :
    • a skin prick test is positive when the wheal is > 3mm larger than the diluent
    control,
    •a RAST is positive if > class 3 or > 3.5 IU/mL.
    These tests must have been performed during the preceding year. If none is available, a
    skin test should be performed at Visit 1.
    At Visit 2
    • Have rhinitis symptoms of such severity that the mean T4SS (Total 4 Symptom Score:
    Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus) over the baseline period must be≥6. The mean T4SS is calculated taking into account only the days on which the
    scores of these four symptoms are available. For this reason, the selection period can be reduced up to three days or increased up to seven days if necessary.
    The rhinitis symptoms (Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and
    Nasal Congestion) must be evaluated and recorded on the diary card by the subjects
    using the following scale:
    0 = Absent
    1 = Mild (present but not disturbing)
    2 = Moderate (disturbing but not hampering daytime activities and/or sleep)
    3 = Severe (hampering daytime activities and / or sleep)
    E.4Principal exclusion criteria
    To enter study at Visit 1, subjects should not:
    • Be pregnant (positive urinary pregnancy test) or lactating,
    •Have an ear, nose, throat (ENT) infection during the two weeks preceding Visit 1 (e.g.sinusitis, purulent rhinorrhea, common cold…),
    •Have an associated asthma requiring corticosteroid treatment,
    •Have an atopic dermatitis or an urticaria requiring an antihistamine treatment or the
    administration of oral or topical corticosteroids,
    •Have an associated ENT disease such as vasomotor rhinitis, significant chronic
    sinusitis, obstructive nasal polyposis, obstructive deviation of the nasal septum, rhinitismedicamentosa,
    •Have another clinically significant disease (cardiovascular, hepatic, renal, auto-immuneor associated with hematology, neurology, psychiatry), or any other disease whichwould disturb absorption, distribution, metabolism or excretion of the investigationalproducts,
    •Be initiating or changing the dose of an immunotherapy regimen during the course ofthe study or during the preceding month
    •Have to use during the course of the study any of the following medications or have
    used them within the specified wash-out periods :
    intranasal or systemic corticosteroids 30 days
    ketotifen 14 days
    nedocromil, cromoglicate 14 days
    other topical corticosteroids 14 days
    loratadine, desloratadine 10 days
    leukotriene antagonists or synthesis inhibitors 7 days
    other antihistamines 3 days
    decongestants (per os, nasal spray or drops) 3 days
    •Be hypersensitive to levocetirizine or its excipients, or to any other piperazine
    derivatives such as hydroxyzine, cetirizine, cyclizine, meclozine, buclizine,
    •Be hypersensitive to desloratadine or its excipients.
    •Known lack of response to H1-antihistamine treatment,
    •Be incapable of giving their written informed consent,
    •Be expected to be non compliant with the study treatments or with the requirements of the protocol,
    •Have a history of alcoholism, drug addiction, mental instability,
    •Have participated in a clinical trial during the last three months,
    •Have already been selected in this study,
    •Be intending to donate blood during the study,
    •Be neither an investigator, a co-investigator, their children or spouses, nor anyone of the study co-workers
    To continue the study at Visit 2, subjects should not:
    • Have a selection period (Visit 1-Visit 2) inferior to three days or superior to seven days
    •Have a mean T4SS < 6 over the selection period
    Have taken any prohibited medication during the selection period
    • Have presented during the selection period with any of the exclusion criteria checked at Visit1
    E.5 End points
    E.5.1Primary end point(s)
    Criteria for evaluation :
    Efficacy variables :
    Primary:
    Change from the baseline of T4SS (T4SS: sum of the individual symptom scores for
    sneezing, rhinorrhea, nasal pruritus, ocular pruritus, evaluated on a 4-point scale
    retrospectively over the past 24 hours) over two weeks of treatment with
    Levocetirizine 5 mg, Desloratadine 5 mg or placebo.
    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 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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) Yes
    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
    The end of trial is defined as the date of database lock as, at that time, interactions between the Sponsor and the Investigator(s) with possible impact on subjects data have ended.
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 2005-03-22. 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state260
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 729
    F.4.2.2In the whole clinical trial 729
    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 Decision2005-05-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-04-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2005-12-09
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