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    Summary
    EudraCT Number:2014-000306-36
    Sponsor's Protocol Code Number:XEN-D0501-CL-04
    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:2014-03-31
    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 number2014-000306-36
    A.3Full title of the trial
    A double-blind, randomised, placebo-controlled, crossover study to assess the efficacy of XEN D0501, a TRPV1 antagonist, in reducing the frequency of cough in patients with chronic idiopathic cough
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A controlled study to look into reducing the number of times a patient suffering from an unexplained cough actually needs to cough by using the investigation medicine XEN-D0501.
    A.4.1Sponsor's protocol code numberXEN-D0501-CL-04
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorXention Limited
    B.1.3.4CountryUnited Kingdom
    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 supportXention Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationXention Limited
    B.5.2Functional name of contact pointChief Medical Officer
    B.5.3 Address:
    B.5.3.1Street AddressIconix Park, London Road, Pampisford
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB22 3EG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+ 441223493900
    B.5.5Fax number+ 44 1223493901
    B.5.6E-mailinfo@xention.com
    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 nameXEN-D0501
    D.3.2Product code XEN-D0501
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNNone
    D.3.9.1CAS number None
    D.3.9.2Current sponsor codeXEN-D0501
    D.3.9.3Other descriptive nameBAY 69-9426, BR4874
    D.3.9.4EV Substance CodeSUB31588
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 Cough
    E.1.1.1Medical condition in easily understood language
    A persistent cough, the cause of which is unknown.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10066656
    E.1.2Term Chronic cough
    E.1.2System Organ Class 100000004855
    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 effectiveness of XEN-D0501 over placebo in reducing objective daytime cough frequency.
    E.2.2Secondary objectives of the trial
    To evaluate the effectiveness of XEN-D0501 over placebo using:
    - capsaicin cough responses,
    - objective 24-hour cough frequency,
    - hourly change in cough frequency,
    - cough severity (via visual analogue scale [VAS]),
    - urge to cough (via VAS)
    - global rating of change scale,
    - Leicester Cough Questionnaire (LCQ),
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female patients aged 18 years or over with chronic idiopathic cough, defined as:
    a) Attending a specialist cough clinic with a history of cough for more than 8 weeks
    b) Idiopathic cough (defined as a cough for which no objective evidence of an underlying trigger can be determined after investigation) or treatment-resistant cough (defined as a cough that is unresponsive to 8 weeks of targeted treatment for identified underlying triggers including reflux disease, asthma and post-nasal drip).
    2. Normal chest radiography i.e., chest X-ray or CT thorax, prior to the study (within 12 months of Visit 1)
    3. Normal spirometry (i.e. forced expiratory volume in 1 second [FEV1] >80% predicted)
    4. Day time cough frequency >1.5 coughs/hour (from 24-hour cough monitor at Visit 3),
    5. Emax from capsaicin challenge >10 coughs (from challenge cough monitor at Visit 3),
    6. Women must be of non-child bearing potential.
    a) Non-child bearing potential is defined as amenorrhoeic for at least 1 year AND, if aged under 60 years, have serum follicle stimulating hormone [FSH] level of at least 30 IU/L or have undergone a hysterectomy or bilateral oophorectomy (tubal ligation is not acceptable). Women who are taking hormone replacement therapy (HRT) do not have to have FSH assessments, but the amenorrhea (before starting HRT) must have been naturally (spontaneously) occurring and have been accompanied by an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms).
    b) If female partners of male patients are of childbearing potential, the patient must be willing to use contraception (e.g. condoms plus spermicide) AND their female partner must also be using contraception (e.g. hormonal or intra-uterine device). This double contraception must be used from the first dose of study drug until at least 90 days after the last dose of study drug.
    7. Written informed consent.
    E.4Principal exclusion criteria
    1. Body Mass Index (BMI) >35 kg/m2,
    2. Current smokers or patients with urine cotinine ≥500 ng/mL,
    3. Ex-smoker of <6 months,
    4. Cumulative smoking history of ≥10 pack years
    5. Upper respiratory tract infection within the last 6 weeks prior to randomisation (Visit 3),
    6. Feverish illness within the last 1 week prior to randomisation (Visit 3),
    7. Concomitant medications which may influence cough or interact with study drugs e.g. opioids, gabapentin, pregabalin, amitriptyline, ACE inhibitors, potent CYP3A4 inhibitors (such as ketoconazole, clarithromycin or HIV protease inhibitors) and systemic corticosteroids (use of local injectable, topical or inhaled corticosteroids is permitted),
    8. Patients with concomitant conditions which may influence the cough reflex or the patient’s ability to participate in the study e.g. diabetes, cerebrovascular disease, Parkinson’s disease,
    9. History of drug or alcohol dependency or abuse within approximately the last year prior to screening (Visit 1),
    10. Regular alcohol consumption; >21 units/week for males, or >14 units/week for females, during the study (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine),
    11. Any known allergy to the study drugs,
    12. Pregnant and/or lactating women,
    13. History or evidence of urinary retention, bladder outlet obstruction or benign prostatic hypertrophy,
    14. Any clinically significant abnormalities in haematology or clinical biochemistry tests prior to randomisation (Visit 3),
    15. Serum alanine transaminase (ALT), aspartate transaminase (AST) or gamma-glutamyl transpeptidase (GGT) greater than twice the upper limit of normal (ULN) at Visit 1,
    16. Total serum bilirubin >1.5x ULN at Visit 1,
    17. History of any kind of cancer within the last 5 years unless non-invasive, in remission and approved in writing by Sponsor,
    18. Evidence of any other clinically significant disease or condition which in the opinion of the investigator would preclude the patient’s participation in this study,
    19. QTcF value at Visit 1 (mean) of >450 msec (males) or >470 msec (females),
    20. Patients with uncontrolled hypertension, systolic blood pressure >160 mmHg or diastolic blood pressure >90 mmHg at Visit 1 (mean) or Visit 2,
    21. Received investigational or marketed products as part of any other clinical study within 30 days (or 5 half-lives whichever is longer) prior to screening (Visit 1),
    22. Patient is unable or unwilling to co-operate with the study procedures.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline after 14-days treatment in objective daytime cough frequency on XEN-D0501 compared to placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 14 days
    E.5.2Secondary end point(s)
    Change from baseline after 14 days treatment for XEN D0501 compared to placebo for the following parameters:
    - capsaicin cough response (Emax)
    - objective 24-hour cough frequency
    - hourly change in cough frequency
    - cough severity (VAS)
    - urge to cough (VAS)
    - Leicester Cough Questionnaire
    Difference between XEN-D0501 and placebo after 14 days treatment for :
    - Global rating of change scale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    14 Days
    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 No
    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.8.2.4Number of treatment arms in the trial1
    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 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 No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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 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.1.2.1Number of subjects for this age range: 17
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 8
    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 state25
    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)
    Normal treatment for the condition
    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 Decision2014-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-15
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