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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2005-001936-59
    Sponsor's Protocol Code Number:191622-077
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-08-04
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2005-001936-59
    A.3Full title of the trial
    A multicenter, double-blind, randomized, placebo-controlled, parallel-group, dose-response study of the safety and efficacy of a single treatment of BOTOX® (botulinum toxin type A) purified neurotoxin complex in patients with idiopathic overactive bladder with urinary urge incontinence.
    A.4.1Sponsor's protocol code number191622-077
    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 SponsorALLERGAN LTD
    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.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 Yes
    D. name BOTOX®
    D. of the Marketing Authorisation holderAllergan Pharmaceuticals Ireland
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameBOTOX®
    D.3.2Product code 9060X
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeAGN 191622
    D.3.9.3Other descriptive nameBotulinum toxin type A (from Clostridium botulinum)
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration numberVials of 100 to Allergan Units
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 Yes
    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 placeboPowder for solution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Idiopathic overactive bladder (symptoms of frequency and urgency) with urinary incontinence.
    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 main objective of the study is to evaluate the safety and efficacy of a single treatment of each of 5 doses of BOTOX® compared to BOTOX® Placebo in patients with idiopathic overactive bladder with urinary urge incontinence who have not been adequately managed with anticholinergic therapy. The primary measure is the reduction of weekly frequency of urinary urge incontinence episodes.
    E.2.2Secondary objectives of the trial
    The study will also evaluate the following secondary measures in the study:
    • Number of episodes of micturition
    • Number of episodes of nocturia
    • Number of episodes of urgency
    • 24 hour total volume voided
    • Post void residual urine volume
    • Urodynamic parameters (which include post void residual volume, volume at first involuntary detrusor contraction, maximum cystometric capacity, peak (amplitude) detrusor pressure following first involuntary detrusor contraction, end fill pressure and detrusor compliance)
    • Health outcome measures (which include SF-36, King’s Health Questionnaire (symptoms component only), Incontinence Quality of Life Instrument, EQ-5D, Patient Satisfaction Questionnaire, Patient Global Assessment)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All inclusion criteria are listed since they are all equally important.

    • Patient is male or female, aged 18 to 85 years old
    • Patient weighs ≥ 50 kg (110 lbs)
    • Patient has symptoms of idiopathic overactive bladder (frequency and urgency) with urinary urge incontinence for a period of at least 6 months immediately prior to screening day -15, determined by documented patient history
    • Patient is able to complete study requirements including electronic bladder diary completion, using the toilet without assistance (patient’s incontinence is not due to inability to reach the toilet) and attend all study visits, in the opinion of the investigator
    • Written informed consent has been obtained
    • Patient has negative pregnancy test result if female and of child-bearing potential
    • Written Data Protection consent has been obtained
    • Patient experiences ≥8 episodes of urinary urge incontinence, with no more than one incontinence-free day, determined by completion of patient bladder diary collected over seven consecutive days during the screening period (screening day -14 to randomization day 0)
    • Patient experiences urinary frequency, defined as an average of ≥8 micturitions per day (normal voids only), with no more than one micturition-free day, determined by completion of patient bladder diary collected over seven consecutive days during the screening period (screening day -14 through randomization day 0)
    • Patient has not been adequately managed with one or more anticholinergic drugs for their overactive bladder symptoms, in the opinion of the investigator. Not adequately managed is defined as an inadequate response to or intolerable side effects after at least one month of anticholinergic therapy on an optimized dose
    • Patient is willing to use clean intermittent catheterization (CIC) to empty the bladder or is willing to have an indwelling catheter, if necessary following study treatment
    E.4Principal exclusion criteria
    All exclusion criteria are listed since they are all equally important.

    • Patient has symptoms of overactive bladder due to any known neurological
    reason e.g. spinal cord injury, multiple sclerosis, cerebral vascular accident,
    Alzheimer’s disease, Parkinson’s disease, etc.
    • Patient has received anticholinergic or sympathomimetic medication for the
    treatment of overactive bladder within 21 days of randomization (day 0)
    • Patient uses clean intermittent catheterization (CIC) to manage their urinary
    • Patient has history or evidence of any pelvic or urological abnormalities,
    bladder surgery or disease, other than “overactive bladder”, that may impact
    bladder function including:
    • bladder stones at the time of screening or within 6 months prior to
    • bladder stone surgery within 6 months prior to screening
    • surgery for stress incontinence, uterine prolapse, rectocele, or cystocele
    that has occurred < 1 year from screening
    • current or planned use of an implanted
    electrostimulation/neuromodulation device for treatment of urinary
    incontinence; use of other non-implantable electrostimulatory devices is
    also exclusionary
    • Patient has history or current diagnosis of bladder cancer or has urine
    cytology results which indicate bladder cancer at screening day -15.
    Suspicious urine cytology abnormalities require the investigator’s
    assessment to ensure that the findings are not indicative of malignancy.
    • Patient has a post void residual urine volume >200mL at screening day -15
    • 24 hour total volume voided > 3000 mL of urine, determined by completion
    of patient bladder diary collected during the seven consecutive days during
    the screening period (day -14 to day 0)
    • Patient has a predominance of stress incontinence, determined by patient
    history, in the opinion of the investigator
    • Patient is male with previous or current diagnosis of prostate cancer.
    Patients with a PSA level greater than 4.0 ng/mL will require a biopsy to
    rule out prostate cancer, unless a prostatic biopsy has been performed within
    the past 12 months
    • Patient is male, >40 years of age and has a urine flow rate <12 cc/second at
    screening day -15
    • Patient has serum creatinine level >2 times the upper limit of normal at
    screening day -15
    • Patient has a history of two or more treated urinary tract infections within 6
    months of screening day -15
    • Patient has urinary infection defined as a bacteriuria count of >10^5/mL
    conjoint with leukocyturia >5/hpf at screening day -15
    • Patient has asymptomatic urinary infection, defined as positive nitrites,
    blood and/or leukocyte esterase on urine dipstick reagent strip test at
    randomization day 0
    • A patient with current hematuria ( > 5 RBC/hpf at screening day -15 or
    randomization day 0) or a history of hematuria is excluded; 1) if the
    hematuria is due to a pathologic condition, or 2) is uninvestigated.
    • Patient has active genital infection, other than genital warts, either
    concurrently or within 4 weeks prior to screening day -15
    • Patient has a history of interstitial cystitis, in the opinion of the investigator
    • Patient has evidence of urethral obstruction, in the opinion of the
    investigator at screening day -15 or randomization day 0
    • Patient uses any anti-platelet, anti-coagulant therapy or medications with
    anticoagulant effects within 3 days prior to randomization day 0. Note:
    Some medications can be withheld > 3 days, per clinical judgment of the
    investigator. Please refer to Section 8.2.2 Prohibited
    Medications/Treatments for additional details.
    • Patient has hemophilia, or other clotting factor deficiencies or disorders that
    cause bleeding diatheses
    • Patient has previously been treated with any endovesical pharmacologic
    agent (e.g. capsaicin, resiniferatoxin)
    • Patient has had previous or current botulinum toxin therapy of any serotype
    for any condition
    • Patient has a known allergy or sensitivity to any components of the study
    medication, anesthetics or antibiotics to be used during the study
    • Any medical condition that may put the patient at increased risk with
    exposure to BOTOX® including diagnosed myasthenia gravis, Eaton-
    Lambert syndrome or amyotropic lateral sclerosis
    • Females who are pregnant, nursing or planning a pregnancy during the
    study or females of child-bearing potential who are unable or unwilling to
    use a reliable form of contraception during the study
    • Current or previous participation in another therapeutic study within 30
    days of screening day -15
    • Any condition or situation which, in the investigator's opinion, puts the
    patient at significant risk, could confound the study results, or may interfere
    significantly with the patient’s participation in the study
    E.5 End points
    E.5.1Primary end point(s)
    The primary measure is number of episodes of urinary urge incontinence (episodes to be indicated as urge or stress incontinence episodes as applicable), as recorded by patient bladder diary during 7 consecutive days prior to study visit day 0, and during seven consecutive days immediately prior to weeks 2, 6, 12, 18, 24, 30 and 36 (primary endpoint at week 12).
    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 Information not present in EudraCT
    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 Yes
    E.6.13Others Information not present in EudraCT
    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. 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 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.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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 Yes
    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 trial = last visit of the last subject
    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 months11
    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 months11
    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 2005-08-04. 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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 290
    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)
    Patients will be treated for their conditions according to the expected normal treatment of their condition after study participation.
    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 Decision2005-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-21
    P. End of Trial
    P.End of Trial StatusCompleted
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