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    Summary
    EudraCT Number:2014-000222-38
    Sponsor's Protocol Code Number:P00048GP404
    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:2014-08-06
    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 ConcernedGermany - BfArM
    A.2EudraCT number2014-000222-38
    A.3Full title of the trial
    PERMIXON® 160 mg hard capsule versus placebo in the treatment of
    symptomatic lower urinary tract symptoms due to benign prostatic
    hyperplasia.
    Single-blind placebo run-in period then double-blind, randomised,
    multinational, multicentric, placebo-controlled in 3 parallel-group comparative treatment period.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PERMIXON® 160 mg hard capsule versus placebo in the treatment of
    symptomatic lower urinary tract symptoms due to benign prostatic
    hyperplasia.
    A.3.2Name or abbreviated title of the trial where available
    PERLES
    A.4.1Sponsor's protocol code numberP00048GP404
    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 (Represented by: Institut de Recherche Pierre Fabre)
    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 MEDICAMENT
    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 de Développement Pierre Fabre
    B.5.2Functional name of contact pointSouad KHELFAOUI, MD
    B.5.3 Address:
    B.5.3.1Street Address3, avenue Hubert Curien - BP 13562
    B.5.3.2Town/ cityTOULOUSE
    B.5.3.3Post code31035
    B.5.3.4CountryFrance
    B.5.4Telephone number00 335 34 50 61 95
    B.5.5Fax number00 335 34 50 65 92
    B.5.6E-mailsouad.khelfaoui@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 160 mg, 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 160 mg, capsule
    D.3.2Product code P0048
    D.3.4Pharmaceutical form Capsule
    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 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 TAMSULOSINE ARROW LP 0,4 mg, prolonged-release capsule, hard
    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 LP 0,4 mg, prolonged-release capsule, hard
    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 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
    Lower urinary tract symptoms due to benign prostatic hyperplasia.
    E.1.1.1Medical condition in easily understood language
    Lower urinary tract symptomes due to prostata enlagement.
    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 18.1
    E.1.2Level LLT
    E.1.2Classification code 10004447
    E.1.2Term Benign prostatic hypertrophy
    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
    To compare at 6 months (D180) the efficacy of PERMIXON® 160 mg b.i.d to a placebo in subjects with lower urinary tract symptoms (LUTS) due to BPH through the assessment of I-PSS
    E.2.2Secondary objectives of the trial
    Efficacy :
    -To assess the efficacy of PERMIXON® 160 mg hard capsule b.i.d versus placebo at 3 months (D90) through the assessment of I-PSS.
    - To assess the efficacy of PERMIXON® 160 mg hard capsule b.i.d versus placebo at 3 months (D90) and 6 months (D180) through the assessment of quality of life (QoL I-PSS and SF-12) , sexual function (MSF-4) and patient global impression of improvement (PGI-I).
    Tamsulosin Arrow LP 0.4 mg will serve as a positive control in order to validate the sensitivity of the study for all efficacy analyses.
    Safety :
    - To assess the clinical safety of PERMIXON® 160 mg hard capsule b.i.d versus placebo and Tamsulosin Arrow LP 0.4 mg o.a.d. over a period of 6 months of treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male subject
    - Between 45 and 85 years old
    - Subject naive to any prior treatment for LUTS due to BPH
    - Subject with bothersome lower urinary tract symptoms due to BPH such as frequency (daytime or night time), urgency, sensation of incomplete voiding, delayed urination or weak stream
    - Prostate enlargement at digital rectal examination (DRE) suggestive of BPH
    - I-PSS > 12 at enrolment visit and at inclusion visit
    - QoL I-PSS score ≥3 evaluated at enrolment visit and at inclusion visit
    E.4Principal exclusion criteria
    - Urological history such as urethral stricture disease and/or bladder neck disease, active (at enrolment and/or inclusion or recurrent urinary tract infection, stone in bladder or urethra)
    -Any neurologic or psychiatric disease/disorder interfering with detrusor or sphincter muscle
    - Insulin-dependent diabetes mellitus and non-controlled non insulin-dependent diabetes mellitus
    - Known severe renal insufficiency or creatinine clearance < 30 ml/mn
    - Known liver insufficiency or clinically significant abnormal liver function tests
    - History of, or concomitant, cardiac arrhythmia or angina pectoris
    - Orthostatic hypotension at enrolment or inclusion visit
    - Known hypersensitivity to one of the constituents of the study drugs
    - Is participating in another clinical trial
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy parameter :- I-PSS at D-30 , baseline (D01), D90 and D180
    E.5.1.1Timepoint(s) of evaluation of this end point
    D-30 ,D01, D90 and D180
    E.5.2Secondary end point(s)
    Secondary efficacy parameters :
    - I-PSS Quality of life question (QoL I-PSS) at D-30, baseline (D01), D90 and D180
    - Quality of Life questionnaire (SF-12) at baseline (D01), D90 and D180
    - Sexual function questionnaire (MSF-4) at baseline (D01), D90 and
    D180
    - Patient Global Impression of Improvement (PGI-I) at baseline (D01), D90 and D180

    Safety
    - Adverse Events : Continuous collection from consent signature until end of study visit
    - Global physical examination at D-30, D01, D90 and D180 including digital rectal examination (DRE), weight and height only at D-30
    - Vital signs (heart rate & blood pressure measurements) at D-30, D01, D90 and D180
    E.5.2.1Timepoint(s) of evaluation of this end point
    D-30 ,D01, D90 and D180
    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 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) 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 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 trial3
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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 years2
    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 years2
    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.1.1.1In 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: 191
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 382
    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 state110
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 573
    F.4.2.2In the whole clinical trial 573
    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)
    The Sponsor will not supply the tested products after the study end. Nevertheless approved medications in BPH are available on the market, such as α-blockers, 5-α reductase inhibitors, plant extracts and 5-phosphodiesterase inhibitor and may be prescribed by the investigator.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Société ALTI
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-09-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-06-27
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