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    Summary
    EudraCT Number:2006-001449-33
    Sponsor's Protocol Code Number:P04849
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-05-18
    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 ConcernedGreece - EOF
    A.2EudraCT number2006-001449-33
    A.3Full title of the trial
    A study of the efficacy, safety, and quality of life (QOL) in patients with chronic idiopathic urticaria dosed with AERIUS Tablets (5 mg, 10 mg, or 20 mg once daily).
    A.3.2Name or abbreviated title of the trial where available
    ACCEL
    A.4.1Sponsor's protocol code numberP04849
    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 SponsorSchering Plough Research Institute, A Division of Schering Corporation
    B.1.3.4CountryUnited States
    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 Yes
    D.2.1.1.1Trade name Aerius
    D.2.1.1.2Name of the Marketing Authorisation holderSP Europe
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameAerius
    D.3.2Product code SCH 34117
    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 INNdesloratadine
    D.3.9.3Other descriptive namedesloratadine, SCH 34117
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5 to mg
    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 placeboFilm-coated tablet
    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
    Subjects with an active episode of chronic idiopathic urticaria (CIU) and are taking a second-generation antihistamine will be selected for the study. The urticaria activity score (UAS) must be between 10-30, inclusive, at the end of the baseline week (entry period).
    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 primary objective of this study is to compare the effects of desloratadine 20 mg daily with desloratadine 5 mg daily in subjects with chronic idiopathic urticaria. The primary effect variable is the change in the UAS from baseline (Baseline Week - entry period). The primary time point is the final/terminal week of the “Dose-Response Treatment Period”.
    E.2.2Secondary objectives of the trial
    To compare the effects on the UAS changes at the final week of and weekly during the Dose-Response Treatment Period (DRTP) from baseline (Baseline Week) of DL 10 mg vs DL 5 mg daily and DL 20 mg vs DL 10 mg daily in patients with CIU. To compare the percent of responders for each week during the DRTP in each treatment group. To compare the changes at the end of the DRTP (Visit 3) from baseline visit (Visit 2) in the DLQI, ESS, MOS-SS, and Overall Condition of CIU, and responses to the questions about interference with sleep and activities of daily living. To evaluate the patients' assessment of Global Therapeutic Response at Visit 3. To determine the proportion of patients who discontinued from the study. Subgroup analyses based on the prior antihistamine medication will be analyzed for the efficacy variables. Safety information will be collected from the diaries and at each visit.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must satisfy the following criteria before being enrolled/randomized into the study.
    1) Subject must demonstrate willingness to participate in the study.
    2) Subject must be 18 to 75 years of age, of either gender, and any race.
    3) Subject must have had this episode of chronic idiopathic urticaria for at least 6 weeks or more, and has been dosing with a “2nd generation AH” for 2 weeks or longer, and
    4) Subject’s current episode of urticaria is sufficiently symptomatic at the Screening Visit to qualify for this study, in the opinion of the investigator.
    5) Subject has a Baseline Week (entry period) UAS between 10 and 30 inclusive.
    6) Patient must understand and be willing to assess and record symptom scores.
    7) Has voluntarily signed a written informed consent.
    8) Subjects must confirm that all prior medication washout times have been observed.
    9) Subject must confirm that he/she is practicing adequate contraception:
    Female volunteers of childbearing potential (including women who are less than 1 year postmenopausal and women who will be sexually active during the study) must agree to use a medically accepted method of contraception or be surgically sterilized prior to screening, while receiving protocol-specified medication, and for 30 days after stopping the medication. Women who are postmenopausal for >1 year (i.e., women who have experienced 12 consecutive months of amenorrhea) will be exempted from the use of contraception during the study. Nonsterile or premenopausal female subjects must be using a medically accepted method of birth control, ie, double-barrier method (eg, male or female condom and spermicide), oral contraceptive, Depo-Provera, NuvaRing, contraceptive transdermal patch, etc, for female subjects of childbearing potential prior to screening and during the study. Women of childbearing potential should be counseled in the appropriate use of birth control while in the study. Vasectomy or tubal ligation is considered a single barrier. Women who are not currently sexually active must agree and consent to use one of the above-mentioned methods if they become sexually active while participating in the study.
    10) If subject is a female volunteer of childbearing potential, she must have a negative urine pregnancy test at Screening/Visit 1.
    11) Subjects must be free of any clinically relevant disease other than chronic idiopathic urticaria (CIU) that would, in the principal investigator’s and/or sponsor’s opinion, interfere with the conduct of the study or study evaluations.
    12) Subjects must be able to adhere to the dosing and visit schedules and agree to record symptom severity scores, medication times, concomitant medications, and adverse events (AEs) accurately and consistently in a daily diary.
    E.4Principal exclusion criteria
    A subject who meets any of the following exclusion criteria will be disqualified from participation in the study:
    1) Is a female who is pregnant, or intends to become pregnant during the study.
    2) Is nursing, or intends to be nursing during the study or within 90 days after study completion.
    3) Has not observed the designated washout periods for any of the prohibited medications outlined in Section 6.2.
    4) Has used any investigational product within 30 days prior to enrollment.
    5) Have any of the following clinical conditions:
    (a) Symptomatic seasonal or perennial allergic rhinitis.
    (b) Asthma not controlled by short-acting beta-2 agonists used as necessary.
    (c) The presence of permanent severe diseases, especially those affecting the immune system, except urticaria.
    (d) The presence of a permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhea diseases, congenital malformations or surgical mutilations of gastrointestinal tract).
    (e) History of/or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia.
    (f) History of/or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy.
    (g) Evidence of/or a history of significant renal disease.
    (h) Evidence of/or a history of significant hepatic disease.
    (i) Presence of cancer which requires chemotherapy or radiation therapy.
    (j) Presence of glaucoma.
    (k) Presence of urinary bladder neck obstruction with emptying difficulties.
    (l) Presence of acute urticaria .
    (m) BMI > 35
    6) Has any clinically significant deviation from the appropriate reference range in the physical examination, or other clinical evaluation that, in the investigator’s judgment, may interfere with the study evaluation or affect subject safety.
    7) Is in a situation or condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
    8) Is participating in any other clinical study(ies).
    9) Is on the staff, affiliated with, or a family member of the staff personnel directly involved with this study.
    10) Is allergic to or has a history of hypersensitivity to the study drug (desloratadine), to any of its excipients, or to loratadine.
    11) Has the rare hereditary problem of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint(s) for the study is change of the UAS from baseline, that is, the UAS at the end of the Baseline Week (entry period). The primary time point is the final/terminal week (week 4) of the “Dose-Response Treatment Period.” The primary comparison is between the 20 mg and 5 mg groups.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    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 Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Information not present in EudraCT
    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) 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    5 mg desloratadine
    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.8.5.1Number 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
    Last visit of the last case in 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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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.1.3Elderly (>=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 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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 450
    F.4.2.2In the whole clinical trial 600
    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)
    Follow SOC for each subject post study completion.
    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 Decision2007-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-04-04
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