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    Summary
    EudraCT Number:2008-006788-35
    Sponsor's Protocol Code Number:0818D1521
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-11-14
    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 ConcernedFrance - ANSM
    A.2EudraCT number2008-006788-35
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled, 2-period crossover study to evaluate effects of multiple oral doses of S-555739 on nasal allergen challenge in subjects with intermittent grass pollen sensitive allergic rhinitis.
    A.4.1Sponsor's protocol code number0818D1521
    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 SponsorShionogi & Co., Ltd.
    B.1.3.4CountryJapan
    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 nameS-555739
    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.3.9.1CAS number 932372-01-5
    D.3.9.2Current sponsor codeS-555739
    D.3.9.3Other descriptive name[2-(Oxazol-2-yl)-5-(4-{4-[(propan-2-yl)oxy]phenylsulfonyl}piperazin-1-yl)phenoxy] acetic acid
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Allergic rhinitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10001723
    E.1.2Term Allergic rhinitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effects of multiple oral doses of S-555739 100 mg once daily on allergen challenge induced total nasal airway resistance (NAR) between active and placebo treatments at Day 7.
    E.2.2Secondary objectives of the trial
    - To evaluate the effects of multiple oral doses of S-555739 100 mg once daily on allergen challenge induced total nasal airway resistance (NAR) between active and placebo treatments at Day 9
    - To evaluate the effects of multiple oral doses of S-555739 100 mg once daily on nasal peak inspiratory flow, internal nasal luminal volume and minimum cross sectional area between active and placebo treatments
    - To evaluate the effects of multiple oral doses of S-555739 100 mg once daily on nasal symptoms of allergic rhinitis between active and placebo treatments.
    - To evaluate the general safety and tolerability of multiple oral doses of S-555739 100 mg once daily.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following to be included in the study:

    1) Those who understand the procedures of the study and agree to participate in the study by providing written informed consent.
    2) Men and women between 18 and 55 years of age at screening. Women should be no longer of child bearing potential (should be surgically sterilised or should be post-menopausal confirmed by FSH dosage).
    3) Those with body mass index (BMI) of ≥18.0 to <29 kg/m2
    4) Current non-smokers from at least 6 months before the study initiation.
    5) Those judged to be in generally good health and without any clinically significant findings on the basis of the medical history, physical and nasal examination, and laboratory evaluation.
    6) Those who have positive responses to allergen-induced NAC at the screening visit.
    7) Those with at least a documented history, (from the data collected at the screening visit), of seasonal allergic rhinitis during the grass season but are currently asymptomatic.
    8) Those demonstrating a positive percutaneous allergen skin test response to grass pollens (timothy (Phleum pratense), orchard (Dactylis glomerata), ryegrass (lolium perenne), Kentucky blue grass (poa pratensis) and/or sweet vernal grass (anthoxanthum odoratum)).
    9) Must be affiliated with, or a beneficiary of, a French social security system.
    10) The Investigator must consult the "Fichier des Volontaires pour la Recherche Biomédicale" (the "National Index of volunteers") to register each volunteer in the index and to ensure that the exclusion period is respected and that the maximum annual compensation is not exceeded.
    E.4Principal exclusion criteria
    Subjects who meet any of the following criteria must be excluded from the study:

    1) Current or recent past abusers of alcohol (alcohol consumption > 40 grams/day), or those with a positive alcohol breath test at screening or current users or recent past abuser of illicit drugs (amphetamines, benzodiazepines, barbiturates, cannabis, cocaine, opiates).
    2) Women of child bearing potential.
    3) Those who have participated in a clinical trial involving an investigational or marketed drug within 3 months of screening.
    4) Those in a situation or any condition which, in the opinion of the investigator, may interfere with optimal participation in the study.
    5) Those not willing to discontinue grapefruit whole or juice consumption during the study.
    6) Those male subjects not willing to use contraceptive barriers during the study.
    7) Those with a documented evidence of perennial allergic rhinitis at screening.
    8) Those with active allergic rhinitis within 3 weeks prior to randomisation.
    9) Those receiving medications for allergic rhinitis and/or asthma within 3 weeks prior to randomisation.
    10) Those with a history of exclusively seasonal allergic asthma
    11) Those with a positive wheal for house dust mite with no history of perennial disease and that is not clinically associated with symptoms.
    12) Those with a positive skin prick test for at least one of the tree pollens Alder, Hazel tree, Ash tree, and Cypressus ashei
    13) Those with an upper respiratory tract infection (URI), sinusitis, infectious rhinitis, ocular infection, or history of any of these within 3 weeks prior to randomisation.
    14) Those unable to perform the active anterior rhinomanometry procedure.
    15) Those with a baseline total NAR >0.4 Pa/cm3/s.
    16) Those who respond to an intranasal control solution provocation with a >30% increase in total NAR.
    17) Those who do not show PD100 at a 100IR allergen dose at screening test
    18) Those who have undergone major surgical (requiring general anaesthetic) procedures or procedures to the nasopharynx within 4 weeks of screening.
    19) Those with a history of an anaphylactic allergic reaction related to food or administration of either a marketed or investigational drug.
    20) Those currently using any prescription or non-prescription drugs on a regular basis or within 2 weeks prior to screening
    21) Those who have a positive reaction to any of the following tests: HBs antigen, anti-HCV antibodies, anti-HIV1 antibodies, anti-HIV2 antibodies
    22) Those who had used any of the following drugs within the specified period of time: parenteral corticosteroids within 90 days; oral corticosteroids within 30 days prior to randomisation
    23) Those who have donated 400 mL of blood within 12 weeks before randomisation or 200 mL or more within 4 weeks before randomisation or of any amount from screening to first visit
    24) Those who have received immunotherapy within 6 months of screening.
    25) Subject being the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff directly involved in the conduct of the protocol.
    26) Volunteers without health insurance
    27) Volunteers unable to be contacted in case of emergency
    28) The participants belonging to any of the following categories: incarcerated persons, patients in an emergency situation, in-patients with mental disorders.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change in total Nasal Airways Resistance (NAR) after PD100 challenge at Day 7 on active and placebo treatments.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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 No
    E.8.1.6Cross over Yes
    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 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 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 years0
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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 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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state20
    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)
    Provided in the protocol.
    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 Decision2009-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-07-17
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