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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   43973   clinical trials with a EudraCT protocol, of which   7311   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:2005-004281-17
    Sponsor's Protocol Code Number:191622-517-00
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-09-19
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2005-004281-17
    A.3Full title of the trial
    A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Response
    Study to Evaluate the Safety and Efficacy of a Single Treatment of BOTOX®
    (Botulinum Toxin Type A) Purified Neurotoxin Complex Injected into the Prostate
    for the Treatment of Lower Urinary Tract Symptoms in Patients due to Benign
    Prostatic Hyperplasia
    A.4.1Sponsor's protocol code number191622-517-00
    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 Inc.
    B.1.3.4CountryUnited States
    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 AuthorisationGermany
    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 IMPIntraprostatic use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBotulinium toxin type A (from Clostridium botulinium)
    D.3.9.1CAS number 93384-43-1
    D.3.9.2Current sponsor codeAGN 191622
    D.3.9.3Other descriptive nameClostridium botulinum Type A Neurotoxin complex (900 kD)
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100 Allergan Unit
    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 placeboIntraprostatic use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with lower urinary tract symptoms due to Benign Prostatic Hyperplasia

    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10004446
    E.1.2Term Benign prostatic hyperplasia
    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 safety and efficacy of a single treatment of 100 U, 200 U, or 300 U BOTOX® compared with placebo injected into the prostate to treat lower urinary tract symptoms in patients due to benign prostatic hyperplasia.

    E.2.2Secondary objectives of the trial
    None stated
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male, aged 50 years and older
    2. Weight at least 50 kg or 110 lbs
    3. Lower urinary tract symptoms in patients due to benign prostatic hyperplasia based on medical history and digital rectal exam, respectively.
    4. Lower urinary tract symptoms (except incontinence) for at least 3 months by patient report. These symptoms may include any or all of the following obstructive or irritative symptoms: weak urinary stream, prolonged voiding, abdominal straining, hesitancy, intermittency, incomplete bladder emptying,dribbling, frequency, nocturia, urgency, bladder pain, and dysuria.
    5. International Prostate Symptom Score (IPSS) greater than or equal to 12 at the
    screening visit (day -14).
    6. Total prostate volume by transrectal ultrasound of at least 30 mL but not greater
    than 100 mL determined at the screening visit (day -14).
    7. Peak urinary flow rate of at least 5 mL/sec, but not greater than 15 mL/sec with
    a voided urine volume of at least 125 mL at the screening visit (day -14).
    8. Post void residual urine volume less than 200 mL measured by ultrasound or bladder scan at the screening visit (day -14).
    9. If engaging in sexual activities, all patients must use a male condom for 3 months post-treatment irrespective of other contraceptive methods (e.g., vasectomy).
    Patient with a partner of child-bearing potential must also use a spermicide gel or cream with the male condom, if patient has not had a vasectomy or the female partner is not using an oral, patch, injectable contraceptive or intrauterine device (if she has not had a tubal ligation or hysterectomy).
    10. Written informed consent obtained including information regarding the collection, use, disclosure and protection of their personal information or Data Protection consent (European sites only).
    11. Patient is registered in the French social security system and fulfils necessary
    requirements as required by local law (French sites only).
    12. Able and willing to comply with study instructions and visit schedule.
    E.4Principal exclusion criteria
    1. Previous prostate surgery, including minimally invasive procedures (e.g., transurethral needle ablation, transurethral microwave therapy)
    2. Any prostate biopsy within 6 weeks of the screening visit (day -14). Patients will be allowed to be re-screened a minimum of 6 weeks after a negative biopsy result is documented. All other protocol inclusion and exclusion criteria must be met.
    3. Prominent median lobe at the screening visit (day -14), as determined by the investigator’s opinion (e.g., transrectal ultrasound or previous cystoscopy).
    4. Previous or current diagnosis of prostate cancer.
    5. Patient with a Prostate Specific Antigen (PSA) greater than 10 μg/L may not be enrolled. Patients with a total PSA greater than or equal to 4.0 μg/L and less than or equal to 10 μg/L must have prostate cancer ruled out to the satisfaction of the investigator according to local site practice.
    6. Alpha-adrenergic antagonists within 15 days prior to the screening visit (day -14) and patient is unwilling to remain off the medication for duration of the study.
    7. Medications in the following classes within 15 days of the screening visit (day -14) and patient is unwilling or unable to remain off chronic use of these medications for the duration of the study.
    • Alpha-adrenergic agonists
    • Drugs with anticholinergic/antimuscarinic activity if they are indicated for any form of urinary symptoms or bowel disease
    • Antispasmodics, including those indicated for gastrointestinal discomfort
    8. Medication in the following classes within 90 days of the screening visit (day -14) and throughout the duration of the study.
    • 5-alpha-reductase inhibitors
    • Androgens
    • Drugs with anti-androgenic activity (e.g., spironolactone)
    9. Phytotherapy taken for the treatment of prostate diseases or non-specific urinary
    symptoms within 30 days of the screening visit (day -14) and throughout the duration of the study.
    10. Medications with anti-platelet or anti-coagulant (e.g., including acetylsalicylic acid) effect are prohibited for a minimum of 3 days or longer according to clinical judgment of the investigator, prior to any study treatment until the end of the day of treatment (refer to Section 8.2.2 Prohibited Medications/Treatments for details).
    11. Symptomatic prostatitis (acute or chronic) within 12 months of the screening visit (day -14), as determined by patient history.
    12. History or evidence of any urologic abnormalities (e.g., urethral stricture), bladder surgery, or disease (other than BPH) that may impact bladder function.
    13. Evidence of anal stenosis or stricture or any other condition that may preclude the patient from receiving any administration of study procedures which are performed transrectally.
    14. Recurrent urinary tract infections (UTI) defined as 2 or more episodes in the 12
    months prior to the screening visit (day -14) or UTI in the last 6 months prior to
    randomization/ treatment visit (day 1).
    15. Urinary tract infection defined as a bacteriuria count of >10^4 CFU/mL conjoint with leukocyturia >5/hpf at the screening visit (day -14). In addition, patients with a
    lower bacteriuria count who, in the opinion of the investigator, have a UTI should also be excluded.
    16. Urinary tract infection (symptomatic or asymptomatic) at the treatment visit (day 1), prior to randomization. Asymptomatic urinary tract infection defined as positive nitrites, blood and/or leukocyte esterase on urine dipstick reagent test strip.
    17. History or evidence of interstitial cystitis based on the investigator’s opinion.
    18. History or evidence of bladder cancer.
    19. History or evidence of stones in the bladder are excluded. Patients with current
    evidence of asymptomatic stones in the kidney may be enrolled if no active intervention is planned.
    20. History or evidence of urinary incontinence not directly related to benign prostatic hyperplasia (e.g., sphincter conditions).
    21. Acute urinary retention or previous use of indwelling catheter for urinary
    retention within 3 months of the screening visit (day -14), except if urinary
    retention was associated with unrelated surgery and/or general/regional/local
    anesthesia and has resolved without any further intervention.
    22. Urethral instrumentation within 15 days of the screening visit (day -14), including urodynamic assessments (e.g. bladder catheterization).
    23. Previous radiation therapy to the pelvis.
    24. Patient with hematuria (>5 RBC/hpf) at the screening visit (day -14) or a history
    of hematuria is excluded: 1) if the hematuria is due to a pathological condition in the investigator’s opinion, or 2) if the hematuria is uninvestigated.
    25. Diagnosis or findings at the screening visit (day -14) consistent with a known
    primary neurologic condition known to affect bladder function (e.g. multiple sclerosis, Parkinson’s disease, spinal cord injury, stroke).

    Please refer to protocol for criterion 26 to 34.
    E.5 End points
    E.5.1Primary end point(s)
    Change of International Prostate Symptom Score (IPSS) score from baseline at 12 week visit.
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    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. 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA37
    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
    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 months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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 No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 175
    F.4.2.2In the whole clinical trial 350
    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 Decision2007-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-05-27
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