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    Summary
    EudraCT Number:2021-000946-16
    Sponsor's Protocol Code Number:TryptoBPH
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-09-23
    Trial 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 ConcernedPortugal - INFARMED
    A.2EudraCT number2021-000946-16
    A.3Full title of the trial
    TryptoBPH - Proof-of-concept study to evaluate the safety and efficacy of tryptophan in patients with BPH
    TryptoBPH – um estudo de prova de conceito para avaliar a segurança e eficácia do triptofano em pacientes com Hiperplasia Benigna da Próstata
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TryptoBPH - a study to evaluate the safety and efficacy of tryptophan in patients with Benign Prostate Hyperplasia
    TryptoBPH – estudo para avaliar a segurança e eficácia do triptofano em pacientes com Hiperplasia Benigna da Próstata
    A.3.2Name or abbreviated title of the trial where available
    TryptoBPH
    TryptoBPH
    A.4.1Sponsor's protocol code numberTryptoBPH
    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 SponsorCentro Clínico Académico - Braga, Associação (2CA-Braga)
    B.1.3.4CountryPortugal
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support Centro Clínico Académico - Braga, Associação (2CA-Braga)
    B.4.2CountryPortugal
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentro Clínico Académico - Braga, Associação (2CA-Braga)
    B.5.2Functional name of contact pointMónica Gonçalves
    B.5.3 Address:
    B.5.3.1Street AddressHospital de Braga, Piso 1 - Ala E - Lugar de Sete Fontes
    B.5.3.2Town/ cityBraga
    B.5.3.3Post code4710-243
    B.5.3.4CountryPortugal
    B.5.4Telephone number351253027249
    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 Cincofarm
    D.2.1.1.2Name of the Marketing Authorisation holderL. Lepori, Lda
    D.2.1.2Country which granted the Marketing AuthorisationPortugal
    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 Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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.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 Omnic
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Farma, Lda.
    D.2.1.2Country which granted the Marketing AuthorisationPortugal
    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 nametamsulosin
    D.3.4Pharmaceutical form Tablet
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Benign Prostate Hyperplasia
    Hiperplasia Benigna da Próstata
    E.1.1.1Medical condition in easily understood language
    Benign Prostate Hyperplasia
    Hiperplasia Benigna da Próstata
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10065030
    E.1.2Term BPH
    E.1.2System Organ Class 100000004872
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective: to evaluate the effect of tryptophan supplementation on lower urinary tract symptoms (LUTS) as assessed by the International Prostate Symptom Score (IPSS) on patients with known BPH.
    Objetivo Primário: avaliar o efeito da suplementação com triptofno nos sintomas do trato urinário inferior, medidos através do International Prostate Symptom Score (IPSS) em pacientes com Hiperplasia Benigna da Próstata (HBP) conhecida.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of tryptophan supplementation on secondary endpoints, including changes in urine maximum flow rate (Qmax), prostate volume, assessed by trans-rectal ultra-sound, and erectile function, assessed by International Index of Erectile Function-5 (IIEF-5) and in quality of life due to urinary symptoms (question 8 of the IPSS).
    Avaliar o efeito da suplementação com triptofano nos endpoints secundários, incluindo alterações na velocidade máxima de micção (Qmax), do volume da próstata, avaliado pelo ultrassom transrectal, da função eréctil avaliada pelo International Index of Erectile Function-5 (IIEF-5) e na qualidade de vida devido aos sintomas urinários (questão 8 do IPSS).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Written informed consent must be obtained before any assessment is performed;
    • Male patients with BPH for which tamsulosin is the therapeutic option per SoC;
    • Aged ≥50 and less than 75 years old;
    • With prostate volume ≥30 cm3 by TRUS (23);
    • Diagnosed with LUTS defined by a stable IPSS total score ≥13 points;
    • Consentimento informado escrito tem de ser obtido antes de realizar qualquer procedimento;
    • Pacientes homens com HBP para os quais a tansulosina seja a opção terapêutica por prática clínica;
    • Com 50 ou mais anos e menos de 75 anos de idade;
    • Com volume da próstata volume ≥30 cm3 pelo TRUS;
    • Diagnosticado com sintomas do trato urinário inferior, definido com um score IPSS estável de ≥13 pontos;
    E.4Principal exclusion criteria
    • patients with postvoid bladder residual volume ≥250 ml;
    • patients with intravesical obstruction from any cause other than BPH;
    • history of any procedure considered an intervention for BPH;
    • patients with active urinary tract infection;
    • history of recurrent urinary tract infections;
    • current prostatitis or diagnosis of chronic prostatitis;
    • history of prostate or invasive bladder cancer;
    • use of 5 α-reductase inhibitors within 6 months;
    • phytotherapy within 2 weeks before entry;
    • use of serotonin reuptake inhibitors or monoamine oxidase inhibitors.
    • patients with acute or chronic kidney failure;
    • patients with diagnosed or suspicion of intolerance to lactose;
    • patients submitted to general anesthesia in the past 4 weeks.
    • Known intellectual disability that may hampers giving informed consent and would make the patient inappropriate for entry into this study, in the judgment of the investigator.
    • Pacientes com volume residual da bexiga pós-micção ≥250 ml;
    • Pacientes com obstrução intravesical por qualquer outra causa que não seja HBP;
    • História de qualquer procedimento interventivo para HBP;
    • Pacientes com infeção ativa do trato urinário;
    • História de infeções recorrentes do trato urinário;
    • Prostatite atual ou diagnóstico de prostatite crónica;
    • História de cancro da próstata ou invasivo da bexiga;
    • Uso de inibidores da 5 α-redutase nos últimos 6 meses;
    • Fitoterapia nas 2 semanas anteriores à inclusão no estudo;
    • Uso de inibidores da recaptação da serotonina ou inibidores da monoaminoxidase;
    • Pacientes com insuficiência renal aguda ou crónica;
    • Pacientes com diagnóstico ou suspeita de intolerância à lactose;
    • Pacientes submetidos a anestesia geral nas últimas 4 semanas;
    • Incapacidade intelectual conhecida que possa condicionar a capacidade de dar consentimento informado e que, na opinião do investigador, torne a inclusão do participante no estudo inapropriada.
    E.5 End points
    E.5.1Primary end point(s)
    The primary goal of the study is to demonstrate the superiority of tryptophan to tamsulosin for the improvement of LUTS associated with BPH. This will be measured by a change from baseline in the total score (questions 1–7) of the IPSS questionnaire.
    O objetivo primário do estudo é demostrar a superioridade do triptofano em relação à tansulosina na melhoria dos sintomas do trato urinário inferior associados com a HBP. Isto será medido pela alteração do nível basal no score total (questões 1-7) do questionário IPSS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - clinical visit
    - visita clínica
    E.5.2Secondary end point(s)
    There are three secondary efficacy endpoints:
    • Urine maximum flow rate (Qmax);
    • Erectile function, assessed by International Index of Erectile Function-5 (IIEF-5);
    • Prostate volume (in cc), assessed by trans-rectal ultra-sound;
    • Quality of life due to urinary symptoms (question 8 of the IPSS).
    Há 4 endpoints secundários da eficácia:
    • Velocidade máxima de micção (Qmax):
    • Função eréctil, avaliada pelo International Index of Erectile Function-5 (IIEF-5);
    • Volume da Próstata (em cc), avaliado pelo ultrassom transrectal;
    • Qualidade de vida associada aos sintomas urinários (questão 8 do IPSS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    - clinical visit
    - visita clínica
    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 Yes
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    última visita do último participante
    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 months0
    E.8.9.1In the Member State concerned 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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state70
    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)
    None
    Nenhuns
    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 Decision2021-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-17
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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