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    Summary
    EudraCT Number:2009-014049-10
    Sponsor's Protocol Code Number:HP0749GE201
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-10-08
    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 ConcernedFrance - ANSM
    A.2EudraCT number2009-014049-10
    A.3Full title of the trial
    Exploratory study of besipirdine efficacy and safety in male patients with persistent stress urinary incontinence after radical prostatectomy
    A.4.1Sponsor's protocol code numberHP0749GE201
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInstitut de Recherche Pierre Fabre
    B.1.3.4CountryFrance, Metropolitan
    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 No
    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 namebesipirdine hydrochloride
    D.3.2Product code HP749
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNbesipirdine hydrochloride
    D.3.9.2Current sponsor codeHP749
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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*
    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
    Persistant stress urinary incontinence further to radical prostatectomy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10046543
    E.1.2Term Urinary incontinence
    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 clinical efficacy of besipirdine (20 mg b.i.d.) compared to placebo in male patients with persistent stress urinary incontinence further to radical prostatectomy
    E.2.2Secondary objectives of the trial
    To assess the tolerability of besipirdine (20 mg b.i.d.) compared to placebo in male patients with persistent stress urinary incontinence further to radical prostatectomy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male out patients,
    - Aged ≥40 and ≤ 80 years,
    - Stress urinary incontinence following radical prostatectomy (for prostate cancer) persistent for at least 12 months and stable for at least 6 months prior to selection visit,
    - Using pads for Stress Urinary Incontinence,
    - Pad weight between 10 and 75 g at 24-hour home Pad Test (average weight of the 24-hour home pad test performed for 3 consecutive days within the 7 days prior to the inclusion visit),
    - Life expectancy of at least 6 months
    - Having signed his informed consent form,
    - Patient able to fill in self-questionnaires,
    - Affiliated to a social security system, or is a beneficiary
    E.4Principal exclusion criteria
    - Mixed incontinence with predominant Overactive Bladder
    - Urinary incontinence prior to prostatectomy,
    - Neurological pathology that affects the lower urinary tract (Spinal cord lesions, multiple sclerosis, Parkinson’s disease, Diabetes Mellitus ….),
    - Adult nocturnal enuresis,
    - Recent urethral pathology (<6 months) such as fistula, diverticulosis, stenosis,
    - Recent radiotherapy (<6 months)
    - Absence of voluntary micturition (permanent leakage),
    - Polyuria (urinary volume > 3 l/day),
    - Recurrent urinary infection (every 6 months or less),
    - Perineal reeducation on-going or stopped less than 3 months prior to selection,
    - Bad compliance in patient diary completion during the run-in period (i.e. data reported less than 3 consecutive days),
    - Bradycardia (resting HR<50 bpm),
    - Arterial Hypertension (defined as SBP>140 mmHg and/or DBP>90 mmHg or uncontrolled and not stable),
    - Any clinically significant cardiac arrhythmia or conduction disturbance,
    - Evidence of active liver disease (levels of AST or ALT> 2 times the upper normal laboratory value and/or alkaline phosphatase > 1,5 times the upper normal laboratory value)
    - Intake of any treatment known to have an activity on urethral sphincter or detrusor (e.g. anticholinergic, antidepressants, a-stimulants…)
    - Recent start or dosage modification of anti-androgen treatment (< 6 months)
    - Patient known to be non responder to NSRI,
    - Bad compliance to study drug intake during the run-in period (i.e. less than 70%),
    - Alcohol or drug abuse or dependence,
    - Is a family member or work associate (secretary, nurse, technician,…) of the Investigator,
    - Has participated in another clinical trial within the last 3 month(s), has received treatment with known remnant effects or undergone investigation liable to interfere with the present clinical trial,
    - Mentally unable to understand the nature, objectives and possible consequences of the trial; or refusing to subject himself to its constraints,
    - Has forfeited his freedom by administrative or legal award or is under guardianship.
    - Known lactose intolerance,
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy : Leakage volume at 24-hour home Pad test (dry, responder rate, mean volume)Patient Global Impression (PGI) of severity and of change.
    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 Information not present in EudraCT
    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 Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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 concerned4
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state25
    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 Decision2009-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-07-12
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