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    Summary
    EudraCT Number:2011-004594-82
    Sponsor's Protocol Code Number:CSU11001
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-10-20
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2011-004594-82
    A.3Full title of the trial
    Efficacy of an intravesical instillation with neomycin solution in acute cystitis: a double-blind, placebo-controlled trial in patients with permanent intravesical catheter
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    not available
    A.3.2Name or abbreviated title of the trial where available
    Efficacy of intravesical instillation of neomycin solution in patients with acute cystitis and intra
    A.4.1Sponsor's protocol code numberCSU11001
    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 SponsorSchur Pharmazeutika GmbH & Co. KG
    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 supportSchur Pharmazeutika GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSchur Pharmazeutika GmbH & Co. KG
    B.5.2Functional name of contact pointP. Venezia
    B.5.3 Address:
    B.5.3.1Street AddressSchimmelpfennigstrasse 22
    B.5.3.2Town/ cityDüsseldorf
    B.5.3.3Post code40597
    B.5.3.4CountryGermany
    B.5.4Telephone number00492115560881
    B.5.5Fax number0049211570356
    B.5.6E-mailschurvenezia@aol.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 nameNeomycin sulfate solution
    D.3.2Product code not applicable
    D.3.4Pharmaceutical form Intravesical solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravesical use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNEOMYCIN SULFATE
    D.3.9.1CAS number 1405-10-3
    D.3.9.2Current sponsor codenot applicable
    D.3.9.3Other descriptive nameNEOMYCIN SULFATE
    D.3.9.4EV Substance CodeSUB03409MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 placeboIntravesical solution
    D.8.4Route of administration of the placeboIntravesical use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of urinary tract infection
    E.1.1.1Medical condition in easily understood language
    Treatment of urinary tract infection
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10046571
    E.1.2Term Urinary tract infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10046577
    E.1.2Term Urinary tract infections
    E.1.2System Organ Class 10021881 - Infections and infestations
    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 effect of intravesical neomycin sulfate 15 mg/ml (Neomycin sulfate solution) as compared to placebo for the treatment of acute urinary tract infection in patients with permanent intravesical catheter based on the proportion of patients with a result of <10^5 CFU/ml in urine determined by means of Uricult® Trio test (CLED medium) either 24 or 48 hours after the end of 5 days of treatment at the earliest time point at which no measurable concentration of neomycin is registered in urine.
    E.2.2Secondary objectives of the trial
    - To evaluate the proportion of patients with a result of <10^3 CFU/ml
    determined in urine between 24 and 48 hours after the end of treatment
    by means of Uricult® Trio test (CLED medium),
    - To evaluate leukocytes in urine between 24 and 48 hours after the end
    of treatment determined by means of a dipstick test,
    - To evaluate the proportion of patients in which resistance to neomycin
    develops in the course of treatment, defined as at least one type of
    microorganism isolated from the CLED medium of the Uricult® Trio being
    sensitive before treatment and becoming resistant after treatment,
    - To evaluate the ratings of suprapubic tenderness and change in the
    character of the urine by the investigator,
    - To evaluate the ratings of overall efficacy by the investigator.
    - To evaluate the safety of the test product
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1] 18 years and older
    [2] Patients with long term indwelling intravesical catheter (urethral or suprapubic) in place for at least 28 days
    [3] Patients with significant bacteriuria defined as ≥10^5 CFU/ml
    determined bymeans of Uricult® Trio test (CLED medium)
    [4] Patients with ability to follow study instructions and likely to attend
    and complete all required visits
    [5] Written informed consent of the patient
    E.4Principal exclusion criteria
    1. Hypersensitivity to the active substances or to any of the excipients of
    the study drug, or to any related drug
    2. Severe urinary tract infection (e.g. with fever of >39°C) which
    requires systemic antibacterial treatment
    3. Urinary tract infection other than cystitis: pyelonephritis, prostatitis
    4. Urinary tract infection caused by or associated with nephrolithiasis
    5. Cystitis caused by or associated with urolithiasis of the bladder
    6. Exchange of the intravesical catheter during the trial
    7. Patients with chronic kidney disease of stage 3 or higher: glomerular
    filtration rate of less than 60 ml/min or serum creatinine above 150 μmol/l
    8. Treatment with systemic antibiotics within the last 14 days before
    screening or during the trial
    9. Intravesical administration of antibacterial medication (including disinfectants like povidone iodine or similar) within the last 4 days before screening or during the trial
    10. Administration into the catheter of antibacterial medication
    (including disinfectants like povidone iodine or similar) during the trial
    11. Indwelling intravesical catheter with an antibacterial internal coating
    12. Inability to contain the trial medication in the urinary bladder for at
    least 60 minutes on more than 2 occasions
    13. Lesions of the epithelium of the urinary bladder
    14. Hearing or vestibular impairment
    15. Myasthenia gravis
    16. Concomitant intake/administration of muscle relaxing agents
    17. Pregnancy or lactation
    18. Simultaneous participation in another clinical study or participation in any clinical study involving an investigational drug within 3 months prior to start of the present study
    19. Severe physical or mental concomitant diseases that might ham-per
    the realization of the trial according to protocol
    20. Legal incapacity and/or other circumstances rendering the patient
    unable to understand the nature, scope and possible consequences of the study
    21. Unreliability or lack of cooperation
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with a result of <10^5 CFU/ml in urine determined by means of Uricult® Trio test (CLED medium) either 24 or 48 hours after the end of 5 days of treatment at the earliest time point at which no measurable concentration of neomycin is registered in urine.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 5 days of treatment
    E.5.2Secondary end point(s)
    a) proportion of patients with a result of <10^3 CFU/ml in urine determined by means of Uricult® Trio test (CLED medium) either 24 or
    48 hours after the end of 5 days of treatment at the earliest time point at
    which no measurable concentration of neomycin is registered in
    urine
    b) proportion of patients positive for leukocytes in urine determined
    daily for the duration of the trial by means of a dipstick test,
    c) proportion of patients in which resistance to neomycin develops in the
    course of treatment, defined as at least one type of microorganism
    isolated from the CLED medium of the Uricult® Trio being sensitive
    before treatment and becoming resistant after treatment,
    d) ratings of suprapubic tenderness and character of the urine by the
    investigator,
    e) ratings of overall efficacy by the investigator
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 5 days of treatment
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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 Yes
    E.6.13.1Other scope of the trial description
    It is not the aim of the present trial to show complete eradication of bacteria in urine after treatment with the test product.
    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) Yes
    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
    The trial will be performed in up to 2 stages
    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 trial2
    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 concerned20
    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
    End of the clinical part of the trial is the last (final) visit out.
    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 months6
    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 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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2011-10-20. Yes
    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 state400
    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)
    No special treatment from the expected normal treatment of that
    condition. End of the trial is the last (final) visit out.
    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 Decision2012-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-02-19
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