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    Summary
    EudraCT Number:2009-013088-20
    Sponsor's Protocol Code Number:191622-520
    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:2009-08-06
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2009-013088-20
    A.3Full title of the trial
    A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of a Single Treatment of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex Followed by a Treatment with BOTOX® as Applicable in Patients with Idiopathic Overactive Bladder with Urinary Incontinence
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the Safety and Efficacy of BOTOX® in Patients with Idiopathic Overactive Bladder with Urinary Incontinence.
    A.4.1Sponsor's protocol code number191622-520
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00910520
    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 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 supportAllergan Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Ltd
    B.5.2Functional name of contact pointAllergan Ltd, EU Regulatory Affair
    B.5.3 Address:
    B.5.3.1Street Address1st Floor, Marlow International, Parkway
    B.5.3.2Town/ cityMarlow, Bucks
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 01628 494444
    B.5.5Fax number+44 01628 494449
    B.5.6E-mailml-eu_reg_affairs@allergan.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 Yes
    D.2.1.1.1Trade name BOTOX®
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan Ltd
    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 No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBotulinum toxin type A
    D.3.9.1CAS number 93384-43-1
    D.3.9.2Current sponsor codeAGN 191622
    D.3.9.3Other descriptive nameBotox purified neurotoxin complex
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100 to AGN 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) 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 Yes
    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 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
    Patients with symptoms of idiopathic overactive bladder (frequency and urgency) and urinary incontinence, whose symptoms have not been adequately managed with anticholinergic therapy
    E.1.1.1Medical condition in easily understood language
    Overactive bladder with urinary incontinence
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10059617
    E.1.2Term Overactive bladder
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    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 efficacy and safety of BOTOX® 100 U compared with placebo in patients with idiopathic OAB with urinary incontinence whose symptoms have not been adequately managed with anticholinergic therapy.
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent has been obtained.
    2. Written Authorization for Use and Release of Health and Research Study Information (US sites only) has been obtained.
    3. Written Data Protection Consent (EU sites only) has been obtained.
    4. Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable.
    5. Patient is male or female, aged ≥ 18 years old.
    6. Patient weighs ≥ 40 kg (88 lbs).
    7. Patient has symptoms of idiopathic OAB (frequency and urgency) with urinary incontinence for a period of at least 6 months immediately prior to screening, determined by documented patient history.
    8. Patient experiences ≥ 3 episodes of urinary urgency incontinence, with no more than one urgency incontinence-free day, in the 3-day patient bladder diary completed during the screening period (See Section 8.3.2.5 Patient Bladder Diary).
    9. Patient experiences urinary frequency, defined as an average of ≥ 8 micturitions (toilet voids) per day i.e. a total ≥ 24 micturitions in the 3-day patient bladder diary completed during the screening period (See Section 8.3.2.5 Patient Bladder Diary).
    10. Patient has not been adequately managed with one or more anticholinergic agents for treatment of their overactive bladder symptoms, in the opinion of the investigator.
    Not adequately managed is defined as:
    • an inadequate response after at least a 4-week period of anticholinergic therapy on an optimized dose(s), i.e., patient was still incontinent despite anticholinergic therapy, or
    • limiting side effects after at least a 2-week period of anticholinergic therapy on an optimized dose(s).
    An optimized dose is defined as an approved dose for the indication of OAB.
    11. Patient is willing to use clean intermittent catheterization (CIC) to empty the bladder at any time after study treatment if it is determined to be necessary by the investigator.
    12. Patient has a negative pregnancy test result if female and of childbearing potential.
    13. Patient has a negative urine dipstick reagent strip test at Randomization/Day 1 (for nitrites and leukocyte esterase) and, in the investigator’s opinion, patient is asymptomatic for UTI on day of treatment.
    14. Patient is able to complete study requirements including using the toilet without assistance, is able to collect volume voided per micturition measurements over a 24-hour period, complete bladder diaries and questionnaires, and attend all study visits in the opinion of the investigator.
    E.4Principal exclusion criteria
    The following are the key exclusion criteria (not exact wording).
    To ensure patients are not enrolled who are not in the target population:
    No. 1: patient has symptoms of OAB due to a known neurological reason (eg. spinal cord injury or multiple sclerosis)
    No. 2: patient has predominance of stress incontinence
    Ensuring do not enrol patients that are inappropriate, would confound study results or affect response to study treatment:
    No. 3: Patient has received anticholinergics or any other medications/therapies to treat symptoms of OAB including nocutria within 7 days of the start of the screening procedure.
    No. 4: Patient uses CIC or indwelling catheter to mange their urinary incontinence
    No. 5: Patient has been treated with any intravesical pharmacologic agent within 12 months of randomisation
    No. 6: Patient has had previous or current botulinum toxin therapy of any serotype for any urological condition.
    No. 7: Patient has had previous or current botulinum toxin therapy of any serotype for any nonurological condition within 12 weeks of Randomization.
    No. 8: Patient has been immunized for any botulinum toxin serotype.
    No. 9: Patient has history or evidence of any pelvic or urological abnormalities, bladder surgery or disease, other than ‘overactive bladder’, that may affect bladder function. (Note: list given in protocol)
    No. 10: Patient has a history of interstitial cystitis/painful bladder syndrome.
    No. 11: Patient has an active genital infection, other than genital warts, either concurrently or within 4 weeks prior to screening.
    No. 12: Patient has a history or current diagnosis of bladder cancer or other urothelial malignancy, and/or has uninvestigated suspicious urine cytology results.
    No. 13: Patient is male with previous or current diagnosis of prostate cancer or a prostate specific antigen (PSA) level of > 10 ng/mL at screening. Patients with a PSA level of ≥4 ng/mL but ≤ 10 ng/mL must have prostate cancer ruled out to the satisfaction of the investigator according to local site practice.
    No. 14: Patient has evidence of urethral and/or bladder outlet obstruction at screening or Randomization.
    No. 17: Patient has a 24hour total volume of urine voided > 3000 mL, collected over 24 consecutive hours during the 3-day bladder diary collection period prior to Randomization.
    Excluding patients based on potential risks associated with study drug or administration procedure:
    No. 15. Patient has a PVR urine volume of > 100 mL at screening.
    No. 16. Patient has had urinary retention or an elevated PVR urine volume that has been treated with an intervention (such as catheterization) within 6 months of screening.
    No. 18: Patient has a history of 2 or more UTIs within 6 months of Randomisation/Day 1 or is taking prophylactic antibiotics to prevent chronic UTIs.
    No. 19: Patient has a serum creatinine level > 2 times the upper limit of normal at screening.
    No. 20: Patient has current or previous uninvestigated hematuria. Patient with investigated hematuria may enter the study if urological/renal pathology has been ruled out to the satisfaction of the investigator.
    No. 21: Patient has hemophilia, or other clotting factor deficiencies, or disorders that cause bleeding diathesis.
    No. 22: Patient cannot withhold any antiplatelet, anticoagulant therapy or medications with anticoagulant effects for 3 days prior to Randomization.
    No. 23: Patient has a known allergy or sensitivity to any botulinum toxin preparation (including the study medication preparation), anesthetics or antibiotics to be used during the study.
    No. 24: Patient has any medical condition that may put them at increased risk with exposure to BOTOX® including diagnosed myasthenia gravis, EatonLambert syndrome, or amyotrophic lateral sclerosis.
    No. 27: Patient has 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.
    Ensuring do not enrol patients at risk of becoming pregnant:
    No. 25: Females who are pregnant, nursing or planning a pregnancy during the study or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study (Note: reliable forms are defined in the protocol).
    E.5 End points
    E.5.1Primary end point(s)
    There are two co-primary measures
    • Number of episodes of urinary incontinence
    • Proportion of patients who have a positive treatment response on the Treatment Benefit Scale (score of either 1 or 2, representing ‘greatly improved’ or ‘improved’)

    The primary time point is Week 12 following the first treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12 post treatment 1
    E.5.2Secondary end point(s)
    The secondary efficacy measures are:
    Number of micturition episodes
    Urinary Incontinence-Specific Quality-of-Life Instrument (I-QOL)
    King’s Health Questionnaire (KHQ)
    Number of urgency episodes.

    E.5.2.1Timepoint(s) of evaluation of this end point
    These will be measured for the duration of the study.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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) 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 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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Russian Federation
    United States
    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
    Provided in protocol
    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 months6
    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 months6
    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: 267
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 267
    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 2009-08-06. 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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 306
    F.4.2.2In the whole clinical trial 534
    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)
    On successful completion of this study, patients may have the opportunity to enroll into a Long Term Follow-up study (191622-096).

    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 Decision2009-09-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-08-17
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