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    Summary
    EudraCT Number:2005-002749-38
    Sponsor's Protocol Code Number:BT0800NED001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-09-01
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2005-002749-38
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled exploratory trial to evaluate a one-week oral treatment with R129160 (60 mg o.d.) in patients with chronic idiopathic urticaria
    A.3.2Name or abbreviated title of the trial where available
    oral treatment with R129160 (60 mg o.d.) in patients with chronic idiopathic urticaria
    A.4.1Sponsor's protocol code numberBT0800NED001
    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 SponsorBarrier Therapeutics nv
    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 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 nameVapitadine
    D.3.2Product code R129160
    D.3.4Pharmaceutical form Oral solution
    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 INNvapitadine
    D.3.9.1CAS number 279253-83-7
    D.3.9.2Current sponsor codeR129160
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 placeboOral solution
    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 10009159
    E.1.2Term Chronic urticaria
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate effect of the IMP on the itch, associated with Chronic Idiopathic Urticaria
    E.2.2Secondary objectives of the trial
    Evaluate the effect of the IMP on the Chronic idiopathic Urticaria lesions
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects, male or female, aged between 18 and 65 (extremes included)
    2. Women of childbearing potential must have a negative urine pregnancy test at screening, must have used a highly effective stable form of birth control (with a failure rate of less than 1%) for at least one month prior to screening and must agree to remain on this effective form of birth control until the first menses after 30 days following the end of study medication treatment. This effective form of birth control consists of oral contraceptives or a contraceptive implant or a depot injection or a contraceptive patch or an IUD.
    3. In addition, women of childbearing potential should use a double barrier method (one of the methods mentioned above under item 6 together with a condom and spermicidal agent or a diaphragm and spermicidal agent) from inclusion up to 7 days after end of treatment.

    4. Confirmed diagnosis of CIU, with history of signs and symptoms for at least 3 days/week during more than 6 consecutive weeks in the 12 months preceding Visit 1, with active disease at the time of inclusion
    5. During run-in period (from Visit 1 to Visit 2), pruritus and wheals present for at least 2 days
    6. At least moderate pruritus (score of 2 or more) and wheals present (score of 1 or more) during the previous 12 hours
    7. Ability to assess their symptom scores accurately and to complete the diary
    8. Availability of signed informed consent prior to beginning clinical trial protocol-specific procedures, indicating an understanding of the purpose of this trial and a willingness to adhere to the treatment regimen and trial procedures described in this clinical trial protocol
    9. In good general health and free of any disease state or physical condition which, in the investigator’s opinion, exposes the subject to an unacceptable risk by trial participation
    E.4Principal exclusion criteria
    Subjects with urticaria associated with a known underlying disease (eg Hodgkin disease, lupus erythematosus, hepatitis, vasculitis, hyperthyroidism), with physical urticaria (cold, heat, sun-induced, pressure or dermographism, aquagenic), with cholinergic urticaria, with hereditary angioedema or with urticaria due to medications, insect bites, food or any other known etiology
    2. Subjects, previously unresponsive to at least two different antihistamines for the treatment of chronic idiopathic urticaria
    3. History of drug allergy to antihistamines, other anti-allergic compounds, quinine or any of the components of the trial medication
    4. History or suspicion of alcohol and/or drug abuse
    5. Subjects having following concomitant disorders: significant hepatic, renal or bone marrow diseases, severe neuropathy including multiple sclerosis, significant psychiatric disorders or any other serious disease (including cancer and subjects known to be HIV positive), significant infection that requires systemic antibiotic treatment
    6. Subjects previously randomized in the trial.
    7. Any disease state or physical condition that, in the investigator’s opinion, may impair evaluation of itch and/or the urticaria, or may interfere with the treatment
    8. Any disease state or surgery known to affect the GI absorption of drugs
    9. Out-of-range laboratory test results that the investigator considers as pathologic
    10. History of heart failure, myocardial infarction within the past six months, cardiac arrhythmia, or under treatment for heart disorders
    11. Clinically significant abnormal ECG-intervals or morphology of the ECG; QT or QTc >470 ms in females or >450 ms in males
    12. Use of following medication, unless discontinued at Visit 1: oral and/or topical antihistaminic compounds, including H2 antagonists (exception for Hismanal®: discontinued for at least 4 weeks before Visit 2); topical corticosteroids; topical immuno-modulating agents; other topical and/or systemic anti-allergic or anti-pruritic agents; non steroidal anti-inflammatory drugs (NSAIDs)
    13. Use of sedatives or hypnotics within 7 days prior to Visit 1
    14. Use of oral corticosteroids; oral immuno-modulating agents; antidepressants, antipsychotics or tranquillizers within 21 days prior to Visit 1
    15. Use of intramuscular or intra-articular corticosteroids 90 days prior to Visit 1
    16. Pregnant or breastfeeding women, or women of childbearing potential not using adequate contraceptives.
    17. Received another investigational drug within the 30 days prior to entry into the trial
    E.5 End points
    E.5.1Primary end point(s)
    For each treatment arm, the change in the average itch severity score over the one week treatment period relative to baseline is summarized as mean, median, standard deviation, range, and distribution-free 95% confidence intervals for the median for both the intention-to-treat and per-protocol population.
    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 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 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) No
    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.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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 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 years1
    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 years1
    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) 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 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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 48
    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)
    None
    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 Decision2006-09-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-12-12
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