Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2011-005307-33
    Sponsor's Protocol Code Number:P00048GP403
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-28
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2011-005307-33
    A.3Full title of the trial
    Exploratory study of L.S.E.S.r. (PERMIXON® 160 mg hard capsule) versus Tamsulosine LP activity on inflammation biomarkers in the treatment of urinary symptoms related to BPH, A multinational, multicentric, randomised, double-blind, parallel-group prospective study
    Estudio exploratorio de la actividad del extracto lípido esterólico de Serenoa repens (PERMIXON® 160 mg cápsulas duras) frente a tamsulosina LP sobre biomarcadores inflamatorios en el tratamiento de los síntomas urinarios relacionados con la HPB. Estudio prospectivo multinacional, multicéntrico, aleatorizado, doble ciego y de grupos paralelos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Exploratory study of L.S.E.S.r. (PERMIXON® 160 mg hard capsule) versus Tamsulosine LP activity on inflammation biomarkers in the treatment of urinary symptoms related to BPH
    Estudio exploratorio de la actividad del extracto lípido esterólico de Serenoa repens (PERMIXON® 160 mg cápsulas duras) frente a tamsulosina LP sobre biomarcadores inflamatorios en el tratamiento de los síntomas urinarios relacionados con la HPB
    A.4.1Sponsor's protocol code numberP00048GP403
    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 SponsorPIERRE FABRE MEDICAMENT
    B.1.3.4CountryFrance
    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 supportPierre Fabre Médicament
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre de Recherche et Développement Pierre Fabre
    B.5.2Functional name of contact pointPETILAIRE-BELLET Christine
    B.5.3 Address:
    B.5.3.1Street AddressCentre de Recherche et Développement Pierre Fabre - BP 13562 - 3, avenue Hubert Curien
    B.5.3.2Town/ cityToulouse
    B.5.3.3Post codeF- 31035
    B.5.3.4CountryFrance
    B.5.4Telephone number003353450635400
    B.5.5Fax number003353450659200
    B.5.6E-mailchristine.petilaire.bellet@pierre-fabre.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 PERMIXON 160mg, hard capsule
    D.2.1.1.2Name of the Marketing Authorisation holderPIERRE FABRE MEDICAMENT
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 namePERMIXON
    D.3.2Product code P0048
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLIPIDOSTEROLIC EXTRACT OF SERENOA REPENS
    D.3.9.2Current sponsor codeP0048
    D.3.9.4EV Substance CodeSUB30163
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 TAMSULOSINE ARROW LP 0,4 mg,
    D.2.1.1.2Name of the Marketing Authorisation holderARROW GENERIQUES
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nametamsulosine Arrow
    D.3.4Pharmaceutical form Prolonged-release capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTAMSULOSIN
    D.3.9.1CAS number 106133-20-4
    D.3.9.4EV Substance CodeSUB10827MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The aim of the proposed study is to assess the activity on inflammation biomarkers of L.S.E.S.r (PERMIXON® 160mg hard capsule) and Tamsulosine LP in the treatment of BPH. The potential links between serum and urinary markers of inflammation and BPH clinical symptoms at baseline and on treatment will be explored.
    El objetivo del estudio propuesto es evaluar la actividad sobre los biomarcadores inflamatorios de L.S.E.S.r (PERMIXON® 160 mg cápsulas duras) y tamsulosina LP en el tratamiento de los síntomas urinarios relacionados con la HPB. Se examinarán los vínculos potenciales entre los marcadores séricos y urinarios de la inflamación y los síntomas clínicos de la HPB en el periodo basal y durante el tratamiento.
    E.1.1.1Medical condition in easily understood language
    No
    NO
    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 LLT
    E.1.2Classification code 10004447
    E.1.2Term Benign prostatic hypertrophy
    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
    Main objective :
    To evaluate the effect of L.S.E.S.r. 160 mg b.i.d. and Tamsulosine LP 0.4 mg o.a.d. at D30 and D90 on biomarkers of inflammation in patients suffering from BPH :
    - Urine inflammation markers on the first urine flow :
    - Gene (mRNA) expression profile of inflammation in BPH
    - Protein expression profile of inflammation in BPH of the main expressed genes
    - Serum inflammation markers :
    - CRP and Sedimentation Rate
    Evaluar el efecto de L.S.E.S.r. 160 mg dos veces al día y de tamsulosina LP 0,4 mg una vez al día en el D30 y D90 sobre los biomarcadores de la inflamación en pacientes que padecen HPB:
    - Marcadores inflamatorios en la primera orina:
    - Perfil de expresión génica (ARNm) de la inflamación en la HPB
    - Perfil de expresión de proteínas de la inflamación en la HPB de los principales genes expresados
    - Marcadores inflamatorios en suero:
    - PCR y velocidad de sedimentación
    E.2.2Secondary objectives of the trial
    -To assess the efficacy of L.S.E.S.r. 160 mg b.i.d. and Tamsulosine LP 0.4 mg o.a.d. through the assessment of I-PSS.
    -To assess the efficacy of L.S.E.S.r. 160 mg b.i.d. and Tamsulosine LP 0.4 mg o.a.d. through the assessment of QoL.
    - To assess the effect of L.S.E.S.r. 160 mg b.i.d. and Tamsulosine LP 0.4 mg o.a.d. on sexual function (MSF-4).
    -To assess the efficacy of L.S.E.S.r. 160 mg b.i.d. and Tamsulosine LP 0.4 mg o.a.d. through the assessment of Qmax.
    -To assess the efficacy of L.S.E.S.r. 160 mg b.i.d. and Tamsulosine LP 0.4 mg
    o.a.d. through the assessment of post-void residual urine volume.
    -To evaluate the effect of L.S.E.S.r. 160 mg b.i.d. and Tamsulosine LP 0.4 mg o.a.d. on prostate volume.

    - To perform an exploratory analysis of the link between inflammation biomarkers and BPH clinical symptoms at baseline and on treatment.
    Eficacia:
    -Evaluar la eficacia de L.S.E.S.r. 160 mg 2 veces/día y tamsulosina LP 0,4 mg 1 vez/día mediante la evaluación de la I-PSS.
    -Evaluar la eficacia de L.S.E.S.r. 160 mg 2 veces/día y tamsulosina LP 0,4 mg 1 vez/día mediante la evaluación de la CdV.
    -Evaluar el efecto de L.S.E.S.r. 160 mg 2 veces/día y tamsulosina LP 0,4 mg 1 vez/día sobre la función sexual (MSF-4).
    -Evaluar la eficacia de L.S.E.S.r. 160 mg 2 veces/día y tamsulosina LP 0,4 mg 1 vez/día mediante la evaluación de Qmáx.
    -Evaluar la eficacia de L.S.E.S.r. 160 mg 2 veces/día y tamsulosina LP 0,4 mg 1 vez/día mediante la evaluación del volumen de orina residual después del vaciado.
    -Evaluar el efecto de L.S.E.S.r. 160 mg 2 veces/día y tamsulosina LP 0,4 mg 1 vez/día sobre el volumen prostático.
    -Realizar un análisis exploratorio del vínculo entre los biomarcadores inflamatorios y los síntomas clínicos de la HPB en el periodo basal y durante el tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male patient
    - Between 45 and 85 years old.
    - Patient with bothersome lower urinary tract symptoms such as pollakiuria
    (daytime or night time), urgency, sensation of incomplete voiding, delayed
    urination or weak stream, existing for over 12 months
    - I-PSS ? 10 at selection visit and ? 12 at randomisation visit (visit 2)
    - Stable patient?s disease at randomisation defined as an absolute difference of 2
    or less on I-PSS between selection and randomisation visits (visit 1 and visit 2)
    - I-PSS QoL score ? 3 evaluated at selection and randomisation visits,
    - 5 mL/s ? maximum urinary flow rate < 15 mL/s for a voided volume ? 150 mL
    and ? 500 mL evaluated at randomisation visit (2 measurements if necessary)
    - Prostatic volume ?30 cm³ determined by transrectal ultrasound at
    randomisation visit (visit 2)
    - Serum total PSA at randomisation visit (visit 2) :
    a) ? 4 ng/mL
    or
    b) ? 10 ng/mL and
    PSA (free) / PSA (total) ? 25% or negative prostate biopsy within the past 6
    months prior to selection visit.
    Ethical /legal considerations:
    - Patient able to understand and sign the informed consent and understand and
    fill in self-questionnaires
    - Having signed his written informed consent
    - Affiliated to a social security system, or is a beneficiary (if applicable in the
    national regulation).
    Características demográficas y basales:
    - Paciente varón
    - Entre 45 y 85 años de edad.
    Criterios diagnósticos:
    - Pacientes con síntomas molestos en las vías urinarias inferiores como polaquiuria (diurna o nocturna), urgencia, sensación de vaciado incompleto, micción retrasada o chorro débil, que prevalecen durante 12 meses
    - I-PSS ≥ 10 en la visita de selección y ≥ 12 en la visita de aleatorización (visita 2)
    - Enfermedad estable del paciente en la aleatorización, definida como una diferencia absoluta de 2 o menos en la I-PSS entre las visitas de selección y de aleatorización (visita 1 y visita 2)
    - Puntuación de CdV en la I-PSS  3 evaluada en las visitas de selección y de aleatorización,
    - 5 ml/s  flujo urinario máximo < 15 ml/s para un volumen vaciado  150 ml y  500 ml, evaluados en la visita de aleatorización (2 mediciones si es necesario)
    - Volumen prostático  30 cm3, determinado por ecografía transrectal en la visita de aleatorización (visita 2)
    - PSA total en suero en la visita de aleatorización (visita 2):
    a)  4 ng/ml
    o
    b)  10 ng/ml y
    PSA (libre) / PSA (total)  25% o biopsia de próstata negativa en los últimos 6 meses antes de la visita de selección.
    Aspectos éticos y legales:
    - Paciente capaz de comprender y firmar el consentimiento informado y rellenar los cuestionarios autoadministrados
    - Ha firmado el consentimiento informado por escrito
    - Afiliado a un sistema de seguridad social o beneficiario laboral (si procede en las normativas nacionales).
    E.4Principal exclusion criteria
    - Post-void residual urine volume > 200 mL (by suprapubic ultrasound) at randomisation visit (visit 2).
    - Urological history :
    Urethral stricture disease and/or bladder neck disease
    Active (at selection and randomisation visits) or recent (< 3 months) or
    recurrent urinary tract infection
    Urinary retention with indwelling catheter or intermittent catheterisation
    History of unprompted acute urinary retention in the past
    Indication of BPH surgery
    Stone in bladder or urethra
    Acute or chronic (documented) prostatitis
    Prostate cancer treated or untreated
    Bladder cancer
    Interstitial cystitis (documented by symptoms and/or biopsy)
    Active upper tract stone disease causing symptoms
    - Patient with history of surgery of the prostate, bladder neck or pelvic region
    - Any local and/or systemic inflammation disorders at selection and randomisation visit
    - Any neurologic or psychiatric disease/disorder interfering with detrusor or sphincter muscle
    - Insulin-dependent diabetes mellitus and non-controlled non insulin-dependent diabetes mellitus
    - Chronic renal insufficiency, with serum creatinine ? 30 % above the upper normal range at randomisation visit (visit 2)
    - History of severe hepatic failure
    - Orthostatic hypotension defined as a decrease of at least 20 mmHg in SBP or 10 mmHg in DBP between supine and 2-minute standing positions at selection (visit 1) and randomisation visit (visit 2)
    - Patient with any severe underlying disease considered as life threatening in the short or medium term
    - Known hypersensitivity to one of the constituents of the study drugs
    - Concomitant medication with at selection visit (visit 1) and randomisation visit (visit 2) :
    Anti-androgens (must be discontinued at least 6 months prior to selection)
    LH-RH analogues (must be discontinued at least 6 months prior to selection)
    5 alpha-reductase inhibitors (must be discontinued at least 3 months prior to selection)
    Plants extracts used for treatment of LUTS (must be discontinued at least 3 months prior to selection)
    Alpha blockers and alpha/beta blockers (must be discontinued at least 1 month prior to selection)
    ACE inhibitors, calcium antagonists, beta blockers or diuretics (except if stable dose and initiated more than 6 weeks prior to selection)
    NSAIDs by systemic route (except aspirin up to 325 mg/day for cardiovascular prophylaxis)
    Corticosteroids by systemic route.
    Antibiotics by systemic route
    Sympathomimetics, antihistamines, antidepressants (anticholinergic), atropine, antispasmodic drugs, antiparkinsonism drugs, pseudoephedrine,
    chlorpheniramine, spironolactone, mepartricine
    - Patient with a history of drug or alcohol abuse
    Características críticas de la enfermedad:
    - Volumen de orina residual después del vaciado > 200 ml (por ecografía suprapúbica) en la visita de aleatorización (visita 2).
    - Antecedentes urológicos:
    Enfermedad estenósica uretral o enfermedad del cuello vesical
    Infección activa (en las visitas de selección y de aleatorización) o reciente (< 3 meses) o recurrente de las vías urinarias
    Retención urinaria con sonda permanente o cateterismo intermitente
    Antecedentes de retención urinaria aguda no súbita en el pasado
    Indicación de cirugía de HPB
    Litiasis vesical o uretral
    Prostatitis aguda o crónica (documentada)
    Cáncer de próstata tratado o no tratado
    Cáncer vesical
    Cistitis intersticial (documentada mediante síntomas o biopsia)
    Litiasis activa en las vías superiores que provoca síntomas

    - Paciente con antecedentes de cirugía de próstata, del cuello vesical o de la región pélvica
    Otras enfermedades:
    - Cualquier trastorno inflamatorio local o sistémico en la visita de selección o de aleatorización
    - Cualquier enfermedad/trastorno neurológico o psiquiátrico que interfiere con el músculo detrusor o esfínter
    - Diabetes mellitus dependiente de insulina y diabetes mellitus no dependiente de insulina no controlada
    - Insuficiencia renal crónica, con creatinina sérica  30% por encima del límite de normalidad superior en la visita de aleatorización (visita 2)
    - Antecedentes de insuficiencia hepática grave
    - Hipotensión ortostática definida como una disminución de al menos 20 mmHg de la PAS o 10 mmHg de la PAD entre las posiciones supina y de bipedestación durante 2 minutos en las visitas de selección (visita 1) y de aleatorización (visita 2)
    - Paciente con cualquier enfermedad grave subyacente considerada como potencialmente mortal a corto y medio plazo
    Relacionados con los tratamientos:
    - Hipersensibilidad conocida a uno de los componentes de los fármacos del estudio
    - Medicación concomitante en la visita de selección (visita 1) y en la visita de aleatorización (visita 2):
    antiandrógenos (deben suspenderse al menos 6 meses antes de la selección)
    análogos de LH-RH (deben suspenderse al menos 6 meses antes de la selección)
    inhibidores de la 5 alfa-reductasa (deben suspenderse al menos 3 meses antes de la selección)
    Extractos de plantas usados para el tratamiento de STUI (deben suspenderse al menos 3 meses antes de la selección)
    bloqueantes alfa y bloqueantes alfa/beta (deben suspenderse al menos 1 mes antes de la selección)
    IECA, antagonistas del calcio, bloqueantes beta o diuréticos (excepto si la dosis es estable y se inició más de 6 semanas antes de la selección)
    AINE por vía sistémica (excepto ácido acetilsalicílico hasta 325 mg/día para profilaxis cardiovascular)
    corticoesteroides por vía sistémica
    antibióticos por vía sistémica
    simpaticomiméticos, antihistamínicos, antidepresivos (anticolinérgicos), atropina, antiespasmódicos, antiparkinsonianos, pseudoefedrina, clorfenamina, espironolactona, mepartricina
    Hábitos:
    - Pacientes con antecedentes de toxicomanía o alcoholismo
    Otros:
    - Paciente cuyo seguimiento podría ser difícil debido a motivos psicológicos, familiares, sociales o geográficos
    - Cualquier trastorno que impida al paciente tomar una decisión y evaluar el desenlace
    - Es un familiar o compañero de trabajo (secretaria, enfermera, técnico,...) del investigador
    - Ha participado en otro ensayo clínico en los últimos 3 meses, ha recibido un tratamiento con efectos remanentes conocidos o se ha sometido a una investigación que pudiera interferir con el presente ensayo clínico
    - Está participando en otro ensayo clínico
    - Mentalmente incapaz de comprender la naturaleza, objetivos y posibles consecuencias del ensayo; o que se niegue a someterse a sus limitaciones.
    - En privación de libertad por sentencia administrativa o legal, o está bajo tutela
    E.5 End points
    E.5.1Primary end point(s)
    Inflammation biomarkers assay in patients suffering from BPH :
    - Urine inflammation markers (mRNA and proteins) on the first urine flow after digital rectal examination (DRE) at D1, D30 and D90
    - Serum inflammation markers at D1, D30 and D90 :
    - CRP and Sedimentation Rate (at 1 hour & 2 hours)
    Principales criterios de la eficacia:
    Análisis de biomarcadores inflamatorios en pacientes que padecen HPB:
    - marcadores inflamatorios en orina (ARNm y proteínas) en la primera micción después del examen rectal digital (ERD) en el D1, D30 y D90
    - marcadores inflamatorios en suero en el D1, D30 y D90:
    - PCR y velocidad de sedimentación (al cabo de 1 y 2 horas)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 01, Day 30, Day 90
    Día 01, Día 30, Día 90
    E.5.2Secondary end point(s)
    Secondary efficacy criteria :
    -Assessment of I-PSS at selection, D1, D30 and D90.
    -Assessment of QoL at selection, D1, D30 and D90.
    -Assessment of sexual function (MSF-4) at D1, D30 and D90.
    -Assessment of Qmax at D1, D30 and D90, by uroflowmetry
    - Assessment of post-void residual urine volume at D1, D30 and D90, by supra-pubic ultrasound
    - Assessment of prostate volume at D1, D30 and D90, by transrectal ultrasound

    Safety criteria
    -Adverse events
    -Physical examination at selection visit and at each visit including body temperature and weight and height (at selection visit only)
    -Vital signs at selection visit and at each visit
    - Evaluación de la I-PSS en la selección, D1, D30 y D90
    - Evaluación de la CdV en la selección, D1, D30 y D90
    - Evaluación de la función sexual (MSF-4) en el D1, D30 y D90
    -Evaluación de Qmáx en el D1, D30 y D90, por uroflujometría
    - Evaluación del volumen de orina residual después del vaciado en el D1, D30 y D90, por ecografía suprapúbica
    - Evaluación del volumen prostático en el D1, D30 y D90 por ecografía transrectal

    Criterios de seguridad
    Acontecimientos adversos
    Exploración física en la visita de selección y en cada visita, incluidos la temperatura corporal, el peso y la estatura (únicamente en la visita de selección)
    Constantes vitales en la visita de selección y en cada visita
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 01, Day 30, Day 90
    Día 01, Día 30, Día 90
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    exploratory study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months14
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months14
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    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)
    NO
    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 Decision2012-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-10-08
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 25 05:49:32 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA