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    Summary
    EudraCT Number:2006-001245-33
    Sponsor's Protocol Code Number:BILA 2006/UCI
    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:2006-07-07
    Trial 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 number2006-001245-33
    A.3Full title of the trial
    Double-blind, randomised, placebo-controlled, phase III study comparing the efficacy and safety of bilastine 20 mg once daily and levocetirizine 5 mg for the treatment of chronic idiopathic urticaria.
    A.4.1Sponsor's protocol code numberBILA 2006/UCI
    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 SponsorFAES FARMA 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 No
    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 nameBilastine
    D.3.4Pharmaceutical form Tablet
    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 INNBilastine
    D.3.9.1CAS number 202189-78-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 No
    D.3.11.8Extractive medicinal product No
    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 Yes
    D.2.1.1.1Trade name Xazal
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma
    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 nameXazal
    D.3.4Pharmaceutical form Film-coated tablet
    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-hydrochloride
    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 No
    D.3.11.8Extractive medicinal product No
    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 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
    Chronic Idiopathic Urticaria
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10021247
    E.1.2Term Idiopathic urticaria
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of the study is to evaluate the efficacy and tolerability of Bilastine 20 mg, compared to Levocetirizine and placebo for the treatment of chronic idiopathic urticaria.
    E.2.2Secondary objectives of the trial
    To assess the overall efficacy of Bilastine for the treatment of each CIU symptom compared to Levocetirizine.
    • Overall assessment by the investigator at the end of treatment using the Global Clinical Impression scale.
    • To assess the patient Quality of Life (QoL) by a specific questionnaire, DLQI.
    • Evaluation of the tolerability of each study drug by assessment of:
    • Adverse events
    • Biological safety by performing two blood tests (haematology and biochemistry) before and after treatment.
    • Cardiologic safety by performing an ECG before and after treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients of either sex between 18 and 70 years of age.
    • Patients with a documented history of chronic idiopathic urticaria for at least 6 weeks prior to entry in the study, characterized by erythematous skin wheals accompanied by itching, occurring regularly, at least 3 times per week.
    • Subjects who have given their informed consent to participate in the study after having received information about the design, aims and potential risks that could result from the study and having been informed that they can refuse to take part in or withdraw from the study at any time.
    • Patients with active chronic idiopathic urticaria in the week before randomization visit (D-7), and at the randomization visit (D0). Patients should have for at least 3 days (consecutive or not) a moderate score (> 2) for at least 2 of the following symptoms.
    -Itching intensity 0 = Absent, 1 = Mild (not annoying), 2 = Moderate (little disruption of activity), 3 = Severe (intense with disruption of activity)
    -Wheals number 0 = Absent, 1 = Some (< 10), 2 = Numerous (>10), 3 = Extensive areas of the body covered
    -Maximum size of the wheals 0 = Absent, 1 = < 1’5 cm, 2 = > 1’5 cm y < 2’5 cm, 3 = ≥ 2’5 cm
    • Patients willing to attend the required visits scheduled in the protocol, and fill in the diary card provided.
    Patients must undergo a medical examination to participate in the study, and it should be normal.
    E.4Principal exclusion criteria
    Patients meeting any of the following criteria may not be enrolled in this study:
    • Patients that suffered other kind of dermatological pathology that can interfere in the evaluation of the chronic idiopathic urticaria: (isolated hereditary angioedema, dermographism, physics urticaria, urticaria due to a medicine or food allergy, infectious urticaria, contact urticaria, urticaria caused by vasculitis and/or colagenosis, paraneoplasic urticaria, parasitary urticaria, urticaria related with thyroid pathology, eczema or athopic dermatitis.
    • Patients who have a history of autoimmune disorders, Hodgkin’s disease, lymphoma, leukemia and generalized cancer.
    • Patients who are taking or have taken any of the following medications prior to enrolment in the study and have not complied with the specified wash-out period: Note: These wash-out periods should refer to the randomisation date.
    - Systemic or topical corticosteroids: 4 weeks.
    - Antihistamines: Astemizole (6 weeks), loratadine and desloratadine (10 days), other systemic antihistamines (3 days).
    - Anti-leukotrienes (3 days)
    - Doxepine (10 days)
    - Delayed-release corticosteroids (3 months).
    - Ketotifen (2 weeks).
    - Tricyclic antidepressants (1 week)
    - Macrolides antibiotics and imidazolic antifungals (systemic)
    - H2 antihistamines.
    - Anticholinergics.
    - Drugs with antihistamine properties (phenothiazine).
    - Sodium chromoglycate, nedocromil. (2 weeks).
    - and any other drug with sedating action, anxiolytics, hypnotics, opioids, neuroleptics.
    For those treatments with no wash-out period in brackets, the interruption of the treatment at the randomization visit is allowed.
    • Hypersensitivity to H1 antihistamines, benzimidazoles or lactose.
    • Severe concomitant disease that could interfere with treatment response (hepatic, renal, cardiovascular), electrocardiographic abnormalities, arrhythmias, recent acute myocardial infarction or neoplastic diseases.
    • Pregnant or breast-feeding women. Women who could potentially become pregnant must use an effective birth control method (oral contraceptives, intrauterine device, condom or diaphragm). The patient’s agreement to use it will be considered sufficient for participation in the study.
    Before the randomization a urine pregnancy test will be conducted in women with childbearing potential.
    • Patients who will be operating heavy machinery or need to drive motor vehicles as an essential part of their profession.
    • Patients with a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study or patients unable to sign the informed consent form
    • Patients unable to comply with the study requirements or unable to complete the patient diary and take the study treatment.
    • Patients who have a known lack of response to H1-antihistamines.
    • Patients who have a recent history (within previous 12 months) of drug addiction or alcohol abuse.
    • Patients whose health could be harmed by their participation in the study.
    • Patients who are currently participating in or have participated in another clinical trial within the last three months.

    Any waiver of these inclusion and exclusion criteria must be approved by the investigator and the Sponsor (or its representative) on a case-by case basis prior to enrolling the subject. This must be documented by both the Sponsor and the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline, in the Total Symptom Score (TSS), over the 28 days of the treatment period according to the patient’s assessment in the diary card. (Reflective symptoms)
    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 Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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) Yes
    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 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 Information not present in EudraCT
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months8
    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 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 2006-07-07. 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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 540
    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 Decision2006-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-09-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-08-07
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