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    The EU Clinical Trials Register currently displays   38462   clinical trials with a EudraCT protocol, of which   6315   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2008-006787-11
    Sponsor's Protocol Code Number:0819D1522
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-01-20
    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 ConcernedUK - MHRA
    A.2EudraCT number2008-006787-11
    A.3Full title of the trial
    A randomized, double blind, placebo-controlled, 2-period cross over study to evaluate effects of S-555739 on prostaglandin D2 (PGD2) induced nasal airway resistance in healthy adult volunteers
    A.4.1Sponsor's protocol code number0819D1522
    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 once daily on prostaglandin D2 (PGD2) induced total nasal airway resistance (NAR) in healthy adult subjects.
    E.2.2Secondary objectives of the trial
    - To evaluate the effects of a single oral dose of S-555739 (100mg) on prostaglandin D2 (PGD2) induced total nasal airway resistance (NAR).
    - To evaluate the effects of S-555739 on the changes in nasal cross sectional area and volume following challenge with a range of doses of PGD2.
    - To measure the effects of S-555739 on the nasal symptoms resulting from challenge with PGD2, including rhinorrhea, nasal congestion, sneezing and pruritis.
    - 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 criteria 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. Male between 18 and 55 years of age at screening.
    3. Those with a body mass index (BMI) of ≥18.0 to <29 kg/m2.
    4. Those judged to be in generally good health and with no clinically significant findings on the basis of the medical history, physical examination and laboratory evaluation.
    5. Those who have positive responses to PGD2 induced NAR (PD75 ≤32 µg) at the screening visit.
    6. Provide written (signed) informed consent to participate in the trial prior to any trial specific screening procedures, with the understanding that the subject has the right to withdraw from the trial at any time, without prejudice.
    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. Smokers within 6 months before the study.
    3. Those who have participated in a clinical trial involving an investigational or marketed drug within 4 weeks 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 with active allergic rhinitis within 3 weeks prior to randomisation.
    7. Those with perennial allergic rhinitis history who present current symptoms or within 3 weeks prior to randomisation.
    8. Those receiving medications for allergic rhinitis and/or asthma within 3 weeks prior randomisation..
    9. Those with an upper respiratory tract infection (URI), sinusitis, infectious rhinitis, ocular infection, or history of any of these within 3 weeks prior to the randomisation.
    10. Those unable to tolerate the active posterior rhinomanometry and / or acoustic rhinometry procedures.
    11. Those with a baseline total NAR >0.4 Pa/cm3/s.
    12. Those who respond to intranasal control solution provocation with a >30% increase in total NAR.
    13. Those who have undergone major surgical (requiring general anaesthetic) procedures or procedures to the nasopharynx within 4 weeks of randomisation.
    14. Those with a history of an anaphylactic allergic reaction related to food or administration of either a marketed or investigational drug.
    15. Those currently using any prescription or non-prescription drugs on a regular basis or within 2 weeks prior to randomisation.
    16. Those who have received immunotherapy within 6 months of randomisation.
    17. Those who have donated 400 mL of blood within 12 weeks before randomisation or 200 mL or more, within the 4 weeks before randomisation or any amount from screening to first visit.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of subjects with a higher PD75 on Day 8 of the S-555739 period than at Day 8 of the placebo period. PD75 is a dose of PGD2 required to induce a 75% increase in total NAR by the PGD2 challenge agent.
    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 months4
    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 No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state16
    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 Decision2008-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-05-30
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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