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    Summary
    EudraCT Number:2008-000968-16
    Sponsor's Protocol Code Number:F1J-FR-HAAB
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-10-21
    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 ConcernedFrance - ANSM
    A.2EudraCT number2008-000968-16
    A.3Full title of the trial
    EFFICACY OF DULOXETINE IN THE TREATMENT OF URINARY INCONTINENCEAFTER PROSTATECTOMIE DUE TO CANCER
    A.3.2Name or abbreviated title of the trial where available
    Dulox-1
    A.4.1Sponsor's protocol code numberF1J-FR-HAAB
    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 SponsorCeRePP
    B.1.3.4CountryFrance
    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
    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.2.1.1.1Trade name YENTREVE
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly
    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 nameduloxetine
    D.3.2Product code duloxetine
    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.3.11 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 Yes
    D.3.11.13.1Other medicinal product typeChemical origin
    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
    We want to evaluate the effect of Duloxetine 40mg BID (80mg daily dose) on the number of urinary incontinence episodes as shown on a 74 days bladder diary, compared to placebo for male which had a prostatectomy due to cancer. We'll also study tolerance and efficacy of duloxetine with Qol questionnaires.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    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 evaluate the effect of Duloxetine 40mg BID (80mg daily dose) on the number of urinary incontinence episodes as shown on a 90 days bladder diary, compared to placebo.
    E.2.2Secondary objectives of the trial
    -to compare the efficacy of Duloxetine versus placebo according to symptomatic scores: USP, ICIQ-SF and Patient Global Impression of Improvement- PGI-I

    -to compare the efficacy on quality of life of Duloxetine versus placebo, using QoL scores ( IIQ-SF, UDI-SF, I-QoL)

    -to evaluate effect of Duloxetine on daily pad consumption, compared with placebo

    -to evaluate effect of Duloxetine on leakage volume as evaluated by an 1 hour pad test (ICS)

    -to evaluate the effect of Duloxetine compared to placebo on mean number of daily voidings and on maximal voided volume as measured on a 7 days bladder diary.

    -to evaluate the impact on depressive symptoms and/or suicidality of Duloxetine compared to placebo, using the Beck Depression Inventory –II (BDI-II)

    -to evaluate the overall safety of Duloxetine in men.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. Male patients of 18 to 70 years old, having undergone a radical prostatectomy more than 1 year ago and suffering of SUI or mixed urinary incontinence with predominant SUI and without detrusor overactivity on urodynamic assessment, with 7 to 28 incontinence episodes as certified with a 7 days bladder diary. An incontinence episode is defined as a noticeable leakage of urine which would soil or wet a pad or an underwear, a containment garment or a clothing . This implies discrete episodes of incontinence .

    b. Controlled prostatic disease (PSA<0,1ng/ml)

    c. Patient consenting to participate to the trial and having signed the informed consent document

    d. Patients having a positive one hour pad test (∆>2gr)

    e. Patient able to fill in micturition chart and questionnaires, ambulatory and able to independently use toilet without difficulty, with no language barrier
    E.4Principal exclusion criteria
    1. Active or recent history (6 months) of urethral stenosis, treated or not

    2. Active or recurrent (3 episodes yearly) history of urinary infection

    3. Uncontrolled or potentially uncontrolled prostrate cancer as defined by a serum PSA >0,1ng/ml

    4. Recent (2 weeks before V0) or actual treatment with alpha-agonists, serotonine-capture inhibitors or anticholinergic-antimuscarinic drugs

    5. History of pelvic floor radiotherapy

    6. Recent (1 month previous to study) pelvic floor training or patient intending to have pelvic floor training during the following 3 months

    7. Maximal urinary flow rate < 15ml/sec

    8. Post-voiding residue > 100ml identified with bladder scan.

    9. Polyuria as defined by a diuresis more than 2500ml.

    10. Detrusor overactivity present during cystometry, with or without any urinary incontinence

    11. Impaired bladder capacity and / or impaired bladder compliance

    12. Severe urinary stress incontinence as defined as more than 12 leakages mentioned in the 3 days bladder diary

    13. History of surgical treatment of stress urinary incontinence (bulking agents, male sling placement, artificial sphincter ...)

    14. Significant neurological disease able to interfere with lower urinary tract symptoms ( multiple sclerosis, Parkinson disease...)

    15. Medication regimen that includes diuretics where dose and/or frequency have not been stable for at least 12 weeks prior to randomization or is anticipated to change during the course of the study.

    16. Have elevated liver function tests meeting the following criteria:
    ALT/SGPT (alanine aminotransaminase) ≥ 3 times the upper limit of normal (ULN) of the laboratory performing the evaluation or Total bilirubin ≥ 1.5 times the ULN of the laboratory performing the tests.

    17. Patients who are investigator site personnel directly affiliated with the study or are immediate family of investigator site personnel directly affiliated with the study

    18. Patient actually participating in another trial or having participated less than 1 month ago.

    19. Patient rating a score of 2 or 3 on Item 9 of the BDI-II

    20. Use of monoamine oxidase inhibitors (MAOIs), Cymbalta (duloxetine), fluvoxamine, ciprofloxacine, enoxacine or other medications with a potential undesirable interaction with duloxetine within 14 days prior to randomization or at any time during the study or within 5 days of discontinuation of study drug

    21. Patient having uncontrolled narrow-angle glaucoma

    22. Patient having a hypersensitivity to duloxetine or any of the inactive ingredients

    23. Liver disease resulting in hepatic impairment

    24. Severe renal impairment (creatinine clearance < 30 ml/min)

    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy measure should be the reduction of at least 50% of the initial number of mean daily leakage episodes, as informed by the bladder diary. The primary efficacy variable will be the percent change (as computed by [(Endpoint- Baseline) / Baseline ] in the incontinent episode frequency from baseline to endpoint. Percent changes will be computed for all randomized patients with at least one post-baseline visit measurement using a last-visit carried-forward approach.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    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.8.3 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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    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
    Last visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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 Information not present in EudraCT
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 90
    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 change of useful treatment
    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 Decision2008-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-19
    P. End of Trial
    P.End of Trial StatusOngoing
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