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    Summary
    EudraCT Number:2009-013334-24
    Sponsor's Protocol Code Number:KN0203Y-001
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-11-19
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-013334-24
    A.3Full title of the trial
    Double-blind placebo-controlled proof of concept study with the µ-receptor agonist KN203 in patients with overactive bladder syndrome
    Double-blind, randomized, parallel groups prospective phase II-a study for 8 weeks with two dosages of KN203 (20 and 40 mg b.i.d.) and placebo
    A.3.2Name or abbreviated title of the trial where available
    KN0203Y-001
    A.4.1Sponsor's protocol code numberKN0203Y-001
    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 SponsorKeyNeurotek Pharma GmbH
    B.1.3.4CountryGermany
    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 nameKN203
    D.3.2Product code KN203
    D.3.4Pharmaceutical form Prolonged-release 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.3.9.2Current sponsor codeKN203
    D.3.9.3Other descriptive name(2R,3R)-1-Dimethylamino-3-(3-methoxy-phenyl)-2-methyl-pentan-3-ol; hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.IMP: 2
    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 nameKN203
    D.3.2Product code KN203
    D.3.4Pharmaceutical form Prolonged-release 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.3.9.2Current sponsor codeKN203
    D.3.9.3Other descriptive name(2R,3R)-1-Dimethylamino-3-(3-methoxy-phenyl)-2-methyl-pentan-3-ol; hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 placeboProlonged-release 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
    Women with urgency-frequency syndrome with urinary incontinence due to detrusor instability diagnosed by cystometry.

    oder

    Patients with overactive bladder with or without urinary urge incontinence due to detrusor instability whereby the diagnosis is based on the patient’s history and and bladder diaries.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10059617
    E.1.2Term Overactive bladder
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10012548
    E.1.2Term Detrusor instability
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of two different dose regimens of KN203 after 8 weeks of treatment in comparison to baseline and between parallel groups and placebo.
    E.2.2Secondary objectives of the trial
    To assess clinical, laboratory, physical safety as well as quality-of-life parameters (King’s Health Questionnaire) following twice daily oral doses of KN203 for 8 weeks.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    In a subset of patients (the study will aim at 30 patients) a pharmacodynamic secondary endpoint (change in detrusor activity as measured by cystometry on day 1 (start of treatment) and day 57 (end of treatment) will be investigated.
    E.3Principal inclusion criteria
    1) Female patients of any racial origin with overactive bladder syndrome with or without urinary urge incontinence

    2) Age 18 – 70 years inclusive

    3) Likely to meet both criteria at study entry in 4 week:
    ������ at least 10 micturitions per 24 h
    ������ at least 2 episodes of urinary urge/urgency per 24 h

    4) Willingness to undergo a diagnostic cystometry (for a subgroup).

    5) For women with child-bearing potential: negative pregnancy test at trial start and highly effective double contraceptive methods throughout the study. Acceptable methods of birth control include: hormonal contraceptives for at least the 28 days (one cycle) before study enrolment or an intra-uterine device (IUD), either of which combined with a barrier method (male or female condom, diaphragm).

    6) Written Informed Consent given and able to understand the Consent Form

    7) Patient is mentally able to fulfill the study requirements
    E.4Principal exclusion criteria
    1) Clinically significant stress urinary incontinence (defined as leakage following more strenuous activity such as climbing stairs, e.g. Stamey grade II or III)
    2) Previous surgery affecting bladder function
    3) Diabetes mellitus
    4) Chronic obstipation with regular use of laxatives
    Pelvic organ prolapse stage III and IV
    5) Urinary incontinence due to neurological disease
    6) Pelvic organ prolapse stage III and IV
    7) Symptoms of urge due to bladder stones, interstitial cystitis, tumour, tuberculosis, or radiotherapy
    8) Symptomatic or recurrent urinary tract infection (more than 3 episodes per year), or a urinary tract infection within two weeks before study enrolment
    9) Significant post voided residual urine (>100 ml) detected by sonography
    10) Polyuria of more than 3 litres per 24 hours
    11) Non-medicinal treatment of urgency and/or incontinence within 3 months before study enrolment (e.g. bladder training). (note: starting non-medicinal treatment for urgency and/or incontinence before study entry is not allowed.)
    12) Electrostimulation implants for urinary incontinence
    13) Indwelling or intermittent catheterisation
    14) Known contraindication/hypersensitivity to opioids
    15) Prescription or over-the-counter medications (including herbal remedies) started within 28 days before study enrolment, unless used for no more than 10 days in total. Paracetamol, acetyl salicylic acid, metoclopramide, or preparations for topical use without systemic effect can be used without restriction (note: the starting of medication before study entry is not allowed)
    16) Therapy within the last 28 days with
    - opioids (including buprenorphine and tramadol, and patches applied to
    the skin thereof)
    - monoamine oxidase (MAO) inhibitors
    - dexamethasone, cimetidine, fluoxetine, fluvoxamine, indomethacin,
    ketoconazole, lansoprazole, omeprazole, paroxetine, probenicid, ticlopidine
    Note: these medications are not permitted during the study
    17) Therapy with diuretics if the patient has had or is planned to have initiation, discontinuation, or change in dose of diuretics 28 days before or during treatment with study medication
    18) Unwillingness to stop therapy with other medicinal treatments for urgency and/or incontinence if these are being taken
    19) Participation in an investigational drug study or device study within one month, of study enrolment, or previous participation in this study, or parallel participation in another study
    20) Known to or suspected of not being able to comply with the study protocol (including completion of patient diary)
    21) Not able to communicate meaningfully with the investigator and staff
    22) Pregnancy and/or lactation
    23) History of alcohol, medication or drug dependency
    24) History of major psychiatric illness, dementia, Parkinson’s disease, epilepsy or suicide risk
    25) Poor general health status ; e.g. NYHA class ≥3; uncontrolled hypertension
    26) Known chronic disease (e.g. hepatic, renal or gastrointestinal) that might effect drug absorption, distribution, metabolism or excretion
    E.5 End points
    E.5.1Primary end point(s)
    Frequency of micturition per 24 h at end of treatment (Visit 8); versus baseline (day 1) and between parallel groups including placebo.
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of life
    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 Yes
    E.8.1.7.1Other trial design description
    All patients go through a single blind placebo run-in phase of 2 weeks
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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
    Last visit of 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 months9
    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 months9
    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 No
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 180
    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)
    After end of trial the patients will receive the standard medical treatment according to medical indication.
    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 Decision2009-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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