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    The EU Clinical Trials Register currently displays   43974   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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    Summary
    EudraCT Number:2005-004281-17
    Sponsor's Protocol Code Number:191622-517
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-09-12
    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 ConcernedItaly - Italian Medicines Agency
    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
    Studio dose-risposta multicentrico, in doppio cieco, randomizzato, controllato con placebo per valutare la tollerabilita` e la sicurezza di una singola somministrazione di BOTOX (tossina botulinica di tipo A), complesso di neurotossina purificata iniettato nella prostata per il trattamento dei sintomi del tratto urinario inferiore in pazienti con Iperplasia Prostatica Benigna
    A.4.1Sponsor's protocol code number191622-517
    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
    B.1.3.4CountryItaly
    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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRoute of administration not applicable
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBotulinum toxin
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.3Concentration number100
    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 No
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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 placeboRoute of administration not applicable
    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.
    Sintomi del tratto urinario inferiore in pazienti con iperplasia prostatica benigna
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10062225
    E.1.2Term Urinary tract pain
    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 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 (LUTS) in patients due to benign prostatic hyperplasia (BPH).
    Determinare la sicurezza e l efficacia di una singola somministrazione con 100 U, 200 U, o 300 U di BOTOX confrontato con placebo, iniettato nella prostata per trattare i sintomi del tratto urinario inferiore (LUTS) in pazienti con iperplasia prostatica benigna (BPH).
    E.2.2Secondary objectives of the trial
    not applicable
    non applicabile
    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 3. Lower urinary tract symptoms in patients due to benign prostatic hyperplasia based on medical history and digital rectal exam; respectively. 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 13 at the screening (day -14) and baseline visit (day 5 to 1). 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 (day -14) and baseline(day 5 to 1) visit. 8. Post-void residual urine volume less than 250 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 a minimum of 3 months post-treatment irrespective of other contraceptive methods (e.g., vasectomy). 10. Patients 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). 11. Written informed consent obtained including information regarding the collection, use, disclosure and protection of their personal information (Canadian sites only) or Data Protection Consent (European sites only). 12. Patient is registered in the French social security system and fulfils necessary requirements as required by local law (French sites only). 13.Able and willing to comply with study instructions and visit schedule.
    1.Maschi, con eta` maggiore o uguale a 50 anni. 2.Peso di almeno 50 kg. 3.Pazienti con sintomi del tratto urinario inferiore dovuti a iperplasia prostatica benigna come documentato rispettivamente dalla storia medica del paziente e da un esame digitale rettale. 4.Sintomi del tratto urinario inferiore (ad eccezione dell incontinenza) riferiti dal paziente per almeno 3 mesi. Questi sintomi possono includere alcuni o tutti i seguenti sintomi di natura ostruttiva o irritativa: flusso urinario debole, tempo di svuotamento prolungato, contrazioni addominali, esitazione, intermittenza, svuotamento vescicale incompleto, sgocciolio, frequenza, nicturia, urgenza, dolore alla vescica e disuria. 5.International Prostate Symptom Score (IPSS) (Scala Internazionale dei Sintomi della Prostata) maggiore o uguale a 13 allo screening (giorno -14) e alla visita basale (giorno da -5 a 1). 6.Volume prostatico totale, definito tramite ecografia transrettale alla visita di screening (giorno -14), di almeno 30 mL ma non maggiore di 100 mL. 7.Picco di flusso urinario di almeno 5mL/sec, ma non maggiore di 15mL/sec con un volume di urina eliminata di almeno 125 mL allo screening (giorno -14) e alla visita basale (giorno da -5 a 1). 8.Volume residuo di urina post-minzionale inferiore a 250 mL, misurato tramite ecografia o scansione vescicale allo screening (giorno -14). 9.In caso di attivita` sessuale, tutti i pazienti dovranno usare un profilattico per un minimo di 3 mesi dopo il trattamento indipendentemente dall uso di altri metodi contraccettivi (e.g. vasectomia). 10.Pazienti con partner fertili dovranno usare anche gel o crema spermicida insieme al profilattico, nel caso non abbiano fatto una vasectomia; oppure le partner dovranno usare un contraccettivo orale, iniettabile o un cerotto contraccettivo, oppure un sistema intrauterino, nel caso non abbiano le tube legate o non abbiano subito un isterectomia. 11.Consenso informato scritto comprendente le informazioni sulla raccolta, l uso, la divulgazione e la protezione dei dati personali (solo per i centri Canadesi) e Consenso scritto sulla Protezione dei Dati (solo per i centri Europei). 12. Pazienti registrati nel sistema socile di sicurezza francese e adempiente a tutti gli obblighi necessari come previsto dalla legge locale (solo per i centri francesi) 13. Pazienti capaci e intenzionati a seguire le istruzioni dello studio e il programma delle visite.
    E.4Principal exclusion criteria
    1.Previous or planned 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 medial lobe at the screening visit (day -14,)as determined by investigator s opinion (e.g., transrectal ultrasound or previous cystoscopy). 4. Previous or current diagnosis of prostate cancer. Investigators are required to rule out prostate cancer to their satisfaction at the screening visit (day -14). In addition, patients with a total PSA greater than 10 ng/mL will require a biopsy to rule out prostate cancer, unless a biopsy has been performed on the patient within the last 12 months. 5. Alpha-adrenergic antagonists within 15 days prior to the screening visit (day -14) and patient is unwilling to remain off the medication for the duration of the study. 6. Medications in the following classes within 15 days of the screening visit (day -14) or patient is unwilling or unable to remain off chronic use of these medications for the duration of the study. (Intermittent use of these drugs is acceptable but must not be taken at least 5 days prior to any study visit.) Alpha-adrenergic agonists Drugs with anticholinergic activity Antispasmodics Parasympathomimetics and cholinomimetics 7. 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) Phytotherapy 8. Medication with anti-platelet or anti-coagulant effect, except low doses of acetylsalicylic acid (75 mg to 125 mg), within 10 days of the treatment visit(day 1). 9. Symptomatic prostatitis (acute or chronic) within 24 months of the screening visit (day -14), as determined by patient history. 10. History or evidence of any urologic abnormalities, bladder surgery, or disease (other than BPH) that may impact bladder function.
    1.Intervento chirurgico alla prostata precedente o pianificato, incluse le procedure minimamente invasive (e.g. ago-ablazione transuretrale, terapia transuretrale con microonde). 2. Biopsia della prostata nelle 6 settimane precedenti la visita di screening (giorno -14). I pazienti potranno eventualmente avere un altra visita di screening quando saranno trascorse almeno 6 settimane da una biopsia il cui risultato e` stato documentato come negativo. Tutti gli altri criteri di inclusione ed esclusione devono essere rispettati. 3. Lobo mediale prominente alla visita di screening (giorno -14), determinato a giudizio dello sperimentatore (e.g. ecografia transrettale o precedente cistoscopia). 4. Diagnosi corrente o precedente di cancro della prostata. Agli sperimentatori viene richiesto di escludere la presenza di cancro della prostata allo screening (giorno -14) scegliendo il metodo che piu` ritengono opportuno. Inoltre i pazienti con un PSA totale maggiore di 10 ng/mL richiederanno una biopsia per escludere la presenza di cancro della prostata, a meno che la biopsia non sia stata effettuata negli ultimi 12 mesi. 5. Uso di antagonisti alfa-adrenergici nei 15 giorni precedenti alla visita di screening (giorno -14) e pazienti che non accettano di rinunciare a questi farmaci per la durata dello studio. 6. Uso di farmaci appartenenti alle seguenti classi nei 15 giorni precedenti alla visita di screening (giorno -14) o pazienti che non accettano di rinunciare all uso cronico di questi farmaci per la durata dello studio (l uso intermittente di questi farmaci e` accettabile ma non dovranno essere assunti almeno 5 giorni prima di ogni visita prevista dallo studio). Agonisti alfa-adrenergici Farmaci con attivita` anticolinergica Antispastici Parasimpaticomimetici e colinomimetici 7. Uso di sostanze appartenenti alle seguenti classi nei 90 giorni precedenti alla visita di screening (giorno -14) e durante tutta la durata dello studio. Inibitori 5-alfa-reduttasi Androgeni Farmaci con attivita` anti-androgenica (e.g. spironolattone) Fitoterapia 8. Farmaci con effetti anti-piastrinici o anti-coagulanti, ad eccezione di bassi dosaggi di acido acetilsalicilico (da 75 mg a 125 mg), nei 10 giorni precedenti alla visita di trattamento (giorno 1). 9. Prostatiti sintomatiche (acute o croniche) nei 24 mesi precedenti alla visita di screening (giorno -14), come documentato nella storia clinica del paziente. 10. Storia o evidenza di qualsiasi anomalia urologica, interventi chirurgici alla vescica, o malattia (oltre alla BPH) che possano impattare la funzione vescicale.
    E.5 End points
    E.5.1Primary end point(s)
    International Prostate Symptom Score (IPSS)
    International Prostate Symptom Score (IPSS) (Scala Internazionale dei Sintomi della Prostata)
    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 No
    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.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.8.2.4Number of treatment arms in the trial4
    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 No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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.1.1Number of subjects for this age range: 0
    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.1.3Elderly (>=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 150
    F.4.2.2In the whole clinical trial 300
    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 Decision2006-09-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-04-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-05-27
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