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    Summary
    EudraCT Number:2004-004590-28
    Sponsor's Protocol Code Number:1207.5
    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:2005-02-23
    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 number2004-004590-28
    A.3Full title of the trial
    Efficacy and safety of 40 mg, 80 mg and 160 mg KUC 7483 BS administered twice daily and 160 mg administered once a day over 8 weeks in patients with overactive bladder syndrome (a double-blind, placebo-controlled, parallel groups, dose-ranging study)
    A.4.1Sponsor's protocol code number1207.5
    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 SponsorBoehringer Ingelheim 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 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 Information not present in EudraCT
    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 namenot available
    D.3.2Product code KUC 7483
    D.3.4Pharmaceutical form Capsule*
    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.3.8INN - Proposed INNn.a.
    D.3.9.1CAS number 476333-91-2
    D.3.9.2Current sponsor codeKUC 7483
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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 namenot available
    D.3.2Product code KUC 7483
    D.3.4Pharmaceutical form Capsule*
    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.3.8INN - Proposed INNn.a.
    D.3.9.1CAS number 476333-91-2
    D.3.9.2Current sponsor codeKUC 7483
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 placeboCapsule*
    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
    Patients aged 18-75 years, of both sexes with symptoms of overactive bladder syndrome for at least 6 months.

    Lower level term (LLT): Overactive bladder (10059617)
    System Organ Class: Renal and Urinary Disorders
    Preferred term: Hypertonic bladder"
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.1
    E.1.2Level LLT
    E.1.2Classification code 10059617
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of this trial is to investigate efficacy, safety and dose response relationship of different oral doses (40 mg, 80 mg and 160 twice daily and 160 mg once-daily) of KUC 7483 BS given over a 8 weeks period when compared to placebo in patients with overactive bladder.
    E.2.2Secondary objectives of the trial
    1. Other endpoints derived from bladder diary
    2. Quality of life
    3. Safety (details in section 5.2 of the protocol)
    4. Population pharmacokinetic analysis of KUC 7322 ZW including exploratory
    covariate screening
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Urinary frequency of more or equal 8 micturitions/ 24 hours,
    Urgency and/or urge urinary incontinence episodes more or equal 1/24 hours
    Is a male or a female outpatient more or equal 18 years and less or equal 75 years of age.
    Has had symptoms of overactive bladder syndrome with symptoms of frequency, with or without nocturia, and urgency with or without urge urinary incontinence, for a minimum of 6 consecutive months prior to the study entry
    Has no language or cognitive barriers,
    Agrees to comply with the requirements of the protocol
    Has signed a written informed consent document prior to entry into the study.
    Is able to use a toilet independently and without difficulty.
    E.4Principal exclusion criteria
    Has known neurologic lesions or conditions (for example, multiple sclerosis, spinal cord lesions, Parkinson’s disease, myasthenia gravis) or local lesions (for example, bladder stones, tumours) that could cause the bladder overactivity
    Has incontinence with significant stress factor (>50% of incontinence episodes due to stress on the bladder diary collected at Visit 3)
    Has active or chronically recurring urinary tract infection (4 or more urinary tract infections per year)
    Had a lower urinary tract surgery within the past 6 months
    Has a significant haematuria (dipstick test ++ or +++)
    Has a current diagnosis of :
    a. urethral pain syndrome (defined by the ICS as an occurrence of recurrent episodic urethral pain usually on voiding, with daytime frequency and nocturia, in the absence of proven infection or other obvious pathology),
    b. interstitial cystitis,
    c. ureteric, bladder, urethral, or rectal fistula
    d. uncorrected congenital abnormality leading to urinary incontinence
    Has a current sign of significant vesical obstruction which in the opinion of the investigator could cause symptoms of urgency
    Has PVR volume ≥ 100 mL within 15 minutes of a spontaneous void.
    Has a current diagnosis or a history of urogenital cancer
    Has a diagnosis of voluminous uterine fibroma or ovarian cyst which in the opinion of investigator could cause symptoms of urgency
    Had continence surgery including periurethral bulk injections or received bladder neck bulking agent therapy, including collagen injections for incontinence, within 6 months prior to Screening Visit (Visit 1)
    Began pelvic floor muscle exercises (for example, Kegel or biofeedback) or a behavioral bladder training program within 3 months prior to Screening Visit (Visit 1)
    Had previous pelvic irradiation
    Has indwelling catheter or intermittent catheterization
    Had received local administration of botulinium toxin within twelve months prior to Screening (Visit 1)
    Risk of increased bleeding or full anticoagulation.
    Is pregnant or nursing women
    Is a woman of childbearing potential (last menstruation equal or less 1 year prior to signing informed consent) not using a medically approved means of contraception for the previous three months (i.e. intra uterine device, oral contraceptives, diaphragm or subdermal implants)
    Has a current diagnosis of diabetes mellitus type I or II
    Has an history of myocardial infarction or any cardiac ischemic condition
    Has an history of known valvular disorders
    Has a tachycardia defined as heart rate at rest above 90 bpm measured twice at 15 to 30 minutes interval
    Has a symptomatic arrhythmia despite antiarrhythmic medication, uncontrolled angina, or a significant abnormality on ECG at Visit 1 that, in the opinion of the investigator, requires investigation or intervention
    Has a history of GI bleeding within the past 5 years or current evidence of GI bleeding (visible or positive FOB test), with the exception of hemorroids
    Has an inflammatory bowel disease, a Crohn disease, an ulcerative colitis, an oesophagitis, a gastritis or a peptic ulcer
    Has a history of and/or active significant alcohol or drug abuse
    Has taken an investigational drug within one month or six half-lives (whichever is greater) prior to Screening (Visit 1)
    Currently participates in another study
    Had previously been randomized in this study
    Has a significant disease other than OAB, which in the opinion of the investigator may either put the patient at risk because of participation in the study or which may influence the results of the study or the patient’s ability to participate in the study
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the change from baseline to Visit 7 (week 8) in average number of micturitions per 24 hour period as recorded during a 7 day period in the bladder diary, compared to placebo.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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) Yes
    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 Information not present in EudraCT
    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 2005-02-23. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 425
    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 Decision2005-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-04-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2005-06-30
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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