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    Summary
    EudraCT Number:2010-020172-30
    Sponsor's Protocol Code Number:191622-100
    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:2010-06-16
    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 number2010-020172-30
    A.3Full title of the trial
    A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Intraprostatic Administration of BOTOX® 200 U (Botulinum Toxin Type A) Purified Neurotoxin Complex to Treat Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test how effective BOTOX is in the treatment of lower urinary tract symptoms (such as weak urinary flow or frequent urination at night) caused by an enlarged prostate
    A.4.1Sponsor's protocol code number191622-100
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01107392
    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 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 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 pointEU Regulatory Affairs
    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+4401628 494444
    B.5.5Fax number+4401628 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 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 No
    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 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 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) 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 placeboIntraprostatic use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH).
    E.1.1.1Medical condition in easily understood language
    Lower urinary tract symptoms associated with an enlarged prostate such as a slow or weak urinary stream or frequent urination during the night.
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10004446
    E.1.2Term Benign prostatic hyperplasia
    E.1.2System Organ Class 10038604 - Reproductive system and breast 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 assess the efficacy of intraprostatic administration of BOTOX 200 U compared with
    placebo to treat LUTS due to BPH
    E.2.2Secondary objectives of the trial
    To assess the safety of BOTOX from intraprostatic injections
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male, aged 45 years and older
    • Weight ≥ 50 kilograms or 110 pounds
    • LUTS due to BPH for at least 6 months prior to screening
    • Previous (during the last 36 months) or current usage of a licensed oral treatment for BPH at an approved dose, for at least a 4 week duration for alpha-adrenergic antagonists and for at least a 24 weeks (6 months) duration for 5ARIs
    - Patients who will continue on adjuvant alpha antagonist therapy during the trial must have been on a stable dose for at least 3 months prior to screening and agree to remain on the same alpha antagonist and dose for the entire duration of the study.
    - Patients who will continue on adjuvant 5ARI therapy during the trial
    must have been on a stable dose for at least 18 months prior to
    screening and agree to remain on the same 5ARI and dose for the entire duration of the study
    • If engaging in sexual activities, all patients must be willing to use a male condom for 48 hours following each treatment
    • Ability to follow study instructions and likely to complete all required visits
    • Written informed consent and data protection consent has been obtained
    • IPSS ≥ 14 at any time prior to Treatment B
    • Peak urinary flow rate of ≥ 4 mL/sec, but ≤ 15 mL/sec (with a voided urine volume ≥125 mL, but ≤ 600 mL)
    • Post void residual (PVR) urine volume ≤ 200 mL
    • Total prostate volume of ≥ 30 mL, but ≤ 80 mL (assessed by transrectal ultrasound, immediately prior to performing the sham procedure).
    • Less than or equal to a 4 point decrease in IPSS from treatment visit A (prior to run in period) to the qualification for treatment B visit (following run-in period)
    E.4Principal exclusion criteria
    •Acute prostatitis within 12 months of screening
    •History or evidence of chronic prostatitis
    •History of two or more UTIs in the 12 months prior to screening or a single UTI in the 6 months prior to screening
    •History or evidence of bladder stones
    •Symptomatic kidney stones or planned active intervention for symptomatic/asymptomatic kidney stones
    •Patient has current or previous uninvestigated hematuria
    •Previous or current diagnosis of bladder cancer, prostate cancer or any other chronic prostate disease other than BPH
    •Prostate biopsy within 24 weeks of screening visit
    •History of previous prostate surgery, including minimally invasive procedures
    •History or evidence of any urological abnormalities, bladder surgery or disease (other than BPH) that may affect lower urinary tract function
    •History of symptoms suggestive of overactive bladder (OAB) in the investigator’s opinion or previous use of an anticholinergic to treat OAB
    •History of any urinary incontinence within 52 weeks of screening visit
    •History or evidence of interstitial cystitis based on investigator’s opinion
    •History or evidence of anal stenosis, stricture, fissure, or any other condition that, in the investigator’s opinion, may preclude the patient from receiving transrectal administration of study treatment
    •Acute urinary retention or previous use of an indwelling catheter for urinary retention within 12 weeks of screening (except if urinary retention was associated with non-urinary tract surgery and/or general/regional anesthesia and has resolved without further intervention)
    •Urethral instrumentation within 2 weeks of screening
    •Any previous or current usage of botulinum toxin therapy of any serotype for any urological condition
    •Botulinum toxin therapy of any serotype for any non-urological usage during the 12 weeks prior to treatment A
    •Patient has been immunized for any botulinum toxin serotype
    •Known allergy or sensitivity to any botulinum toxins or the components of the study medication, anesthetics, sedatives or prophylactic antibiotics to be used during the study
    •Patient who is immunocompromised or has any systemic or local condition which may increase the risk of developing an infection following treatment
    •Any medical condition that may put the patient at increased risk with exposure to BOTOX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
    •Current or history of a neurologic condition known to affect lower urinary tract function or findings at study entry which may be consistent with a neurological condition known to affect lower urinary tract function
    •Current or history of clotting factor deficiencies, platelet disorders or disorders that cause bleeding diathesis
    •Unable to discontinue medications with anti-platelet or anti-coagulant effects including aspirin (acetylsalicylic acid) for a minimum of 3 days prior to any study treatment until the day following study treatment
    •Patient is unable or unwilling to discontinue the following classes of medication for the required washout period and throughout the duration of the study
    oAlpha-adrenergic antagonists (alpha blockers) or 5ARIs (eg finasteride,
    dutasteride), unless continuing as adjuvant therapy
    oCombination therapy with alpha antagonists and 5ARIs
    oPhytotherapy (ie, herbal or plant extracts) for BPH
    oAlpha-adrenergic agonists
    oAnticholinergics/antimuscarinics for any bowel or LUTS, or any other medications indicated for the treatment of OAB
    oAntispasmodics, including those indicated for gastrointestinal discomfort
    oAndrogens (eg, testosterone) and drugs with androgenic activity
    oDrugs with anti-androgenic activity (eg, spironolactone)
    oAny other medication which in the investigator’s opinion may affect lower urinary tract function
    •Current or previous participation in another therapeutic or device study within 30 days of screening
    •Patient has a condition or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
    •Prominent median lobe of the prostate, in the investigator’s opinion (eg, prominent median lobe noticed during the TRUS at the start of sham procedure, or prominent median lobe previously detected during cystoscopy)
    •UTI, defined as a bacteriuria count of >105 colony forming units/mL conjoint with leukocyturia >5/high power field (hpf). Patients with a lower bacteriuria count who, in the opinion of the investigator, have a UTI should also be excluded
    •Prostate specific antigen (PSA) level of ≥10 μg/L. (Patients with a total PSA level of ≥4.0 μg/L and <10 µg/L must have prostate cancer ruled out to the satisfaction of the investigator according to local site practice, prior to randomization)
    •Creatinine level ≥1.5 times the upper limit of the normal range
    E.5 End points
    E.5.1Primary end point(s)
    Intraprostatic BOTOX 200 U is more effective than placebo in improving symptoms due to BPH, as measured by a difference between BOTOX and placebo in mean International Prostate Symptom Score (IPSS).

    BOTOX 200 U has an acceptable safety profile when administered via the transrectal route into the prostate.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12 post treatment visit B
    E.5.2Secondary end point(s)
    • Change from baseline in the total IPSS score at other visits
    • Change from baseline for Qmax
    E.5.2.1Timepoint(s) of evaluation of this end point
    All visits post treatment B
    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 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.7.1.3.1Other 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 concerned3
    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
    Canada
    Korea, Republic of
    Philippines
    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
    The end of the trial is the last visit of the last patient.
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 137
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 137
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 274
    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 return to previous treatment options
    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 Decision2010-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-06-14
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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
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