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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   42330   clinical trials with a EudraCT protocol, of which   6971   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:2004-002971-18
    Sponsor's Protocol Code Number:A00391
    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:2005-10-04
    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 number2004-002971-18
    A.3Full title of the trial
    A monocenter, double-blind, randomized trial, with two parallel groups comparing the clinical efficacy of levocetirizine 5 mg capsules and desloratadine 5 mg capsules taken once a day over 3 weeks of treatment in adult subjects suffering from seasonal allergic rhinitis (SAR) due to grass pollen
    A.4.1Sponsor's protocol code numberA00391
    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.2.1.1.1Trade name Xusal
    D.2.1.1.2Name of the Marketing Authorisation holderUCB 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 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-a-phenylbenzyl)-1- piperazinyl)ethoxy)acetic acid dihydrochloride.
    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.2.1.1.1Trade name Aerius 5mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderSP Europe
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adult subjects suffering from seasonal allergic rhinitis (SAR) due to grass pollen
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.1
    E.1.2Level LLT
    E.1.2Classification code 10039776
    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 subjects’ satisfaction/dissatisfaction (percentage of switches: i.e., subject’s choice after one week of treatment to continue with the administered treatment or to switch to the alternative treatment) after the first week of treatment.

    E.2.2Secondary objectives of the trial
    •To investigate the correlation between the switch
    •and the mean T5SS over the first week of treatment.
    •and the mean change from the baseline in T5SS over the first week of treatment.
    •and the mean of 5 individual symptom scores over the first week of treatment.
    •and the mean change from the baseline in the 5 individual symptom scores over the first week of treatment.
    •To compare levocetirizine 5 mg and desloratadine 5 mg after the first week of treatment in the switched population analyzing the reason for dissatisfaction.
    •To assess, at the end of the study, subjects’ satisfaction/dissatisfaction of their choice of treatment after the first week of treatment.
    •To investigate subject’s evaluation of disease evolution as assessed on the standard 7 point Global Evaluation Scale after the first week of treatment.
    •To evaluate the safety profile of levocetirizine.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    The subjects should meet the following criteria at V1 (or at pre-screening visit (V0) when applicable):

    •Have been informed of the nature and aims of the study (refer to ICF) and have given their written informed consent signed and dated (at V1 or at pre-screening visit (V0)).

    •At least 2-year history of SAR that became symptomatic during annual from grass pollen season and requiring treatment (also at least since 2 years) during annual from grass pollen.

    •Adult subjects older than 18 years of either sex.

    •Out-patients.

    •Positive skin prick test (wheal > 3 mm larger than the diluent control) or RAST (≥ 3.5 IU/ml) to grass pollen (less than 1 year).

    •Female subjects of childbearing potential must agree not to become pregnant during the study. 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 bilateral ovariectomy or a congenital sterility. When sexually active, females of childbearing potential must be using a medically accepted contraceptive method (hormonal birth control, per os, injectable or by implant, for at least 2 months), have had a bilateral tubal ligation, have monogamous relationship with vasectomized partner or agree to use intrauterine device, diaphragm with spermicide or male condom with spermicide. The female subject must understand the consequences and potential risks of inadequately protected sexual activity, be educated about and understand the proper use of contraceptive medthod, and undertake to inform the Investigator of any potential change in status. Female subjects with childbearing potential are eligible if they have a negative urine pregancy test at V1.

    •Subjects considered as reliable and mentally capable of adhering to the protocol (i.e., completing the daily record card), according to the judgement of the Investigator (at V1 or at pre-screening visit (V0)).


    The subjects should meet the following criteria at V2:

    •Minimum mean T5SS of 8 during the baseline 3 to 7 days period.
    E.4Principal exclusion criteria
    To enter the study at Visit 1, the subjects should not:

    •Be pregnant (positive urinary pregnancy test) or lactating.

    •Have an ear, nose and throat (ENT) or eye infection during the two weeks preceding visit 1 (e.g., sinusitis, purulent rhinorrhea, common cold, ...)

    •Have an associated asthma requiring a daily treatment other than β2 short acting agonist prn

    •Have atopic dermatitis or urticaria requiring antihistamine treatment or the administration of oral or topical corticosteroids and any other disease requiring 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, rhinitis medicamentosa

    •Have another clinically significant disease (e.g. cardiovascular, hepatic, renal, auto-immune or associated with haematology, neurology, psychiatry) or any other disease which would disturb absorption, distribution, metabolism or excretion of the investigational products.

    •Be incapable of giving their written informed consent

    •Be initiating or changing the dose of an immunotherapy regimen during the course of the study or during the month preceding visit 1.

    •Intake of medications prohibited before the screening visit V1, with the following wash-out periods:
    •intranasal or systemic corticosteroids (30 days)
    •ketotifen (14 days)
    •nedocromil or cromoglycate (14 days)
    •topical corticosteroids (14 days)
    •loratadine, desloratadine (10 days)
    •leukotriene antagonist or synthesis inhibitors (7 days)
    •H1 antihistamines (3 days)
    •decongestants (per os, nasal sprays or drops) (3 days)

    •Be hypersensive to levocetirizine or its excipients, desloratadine or to any other piperazine derivatives such as hydroxyzine, cetirizine, cyclizine, meclozine, buclizine.

    •Be expected non compliant with the investigational products or with the protocol requirements

    •Have a known lack of response to H1- antihistamines,

    •Have an history of alcoholism, drug addiction, mental instability,

    •Have participated in a clinical trial during the last three months before V1,

    •Have already been selected in this trial

    •Subjects intending to donate blood during the trial

    •The investigator, co-investigators, as well their children or spouses and all the study collaborators should not be enrolled in this study.

    To continue the study at Visit 2, the subjects should not:

    •Have a selection period (Visit 1-Visit 2) inferior to three days or superior to seven days

    •Have a mean T5SS < 8 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 Visit 1

    E.5 End points
    E.5.1Primary end point(s)
    Criteria for evaluation :
    Efficacy variables:
    Primary variable:
    Percentage of subjects who decided to switch to alternative treatment.

    Secondary variables:
    •T5SS over Week 1 – mean absolute score and mean change in score from baseline.
    •Individual symptom scores over Week 1 – mean absolute score and mean change in score from baseline.
    •Global Evaluation Scale score at the end of Week 1.
    •Reasons for switching to alternative treatment at the end of Week 1
    •Number of subjects, at the end of Week 3, satisfied by their choice to switch to alternative treatment

    Exploratory variables:
    •T4SS over Week 1 - mean absolute score and mean change in score from baseline.
    •T4SS over Week 3 - mean change in score from Week 1
    •Individual symptom score over Week 3 - mean change in score from Week 1
    •Time to first feeling of symptom improvement during Week 1
    •Time to first feeling of sufficient symptom improvement during Week 1
    •VAS score rating the speed of overall symptom relief at end of Week 1
    •VAS score rating the severity of blocked nose at randomization and at the end of Week 1 – mean absolute score and mean change in score from randomization to the end of Week 1
    •VAS score rating the speed of blocked nose relief at end of Week 1
    •VAS score rating the impact on quality of sleep and daily activities at end of Week 1
    Safety variables :
    Frequency, severity, nature and duration of adverse events reported by the subjects during the whole duration of the study, physical examination and vital signs.
    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 No
    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 No
    E.8.2.3Other No
    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 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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months3
    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 2005-10-04. 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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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 Decision2005-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-02-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2005-09-22
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