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    Summary
    EudraCT Number:2004-002143-27
    Sponsor's Protocol Code Number:1208.15
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-02-02
    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 ConcernedSweden - MPA
    A.2EudraCT number2004-002143-27
    A.3Full title of the trial
    A double-blind, stratified, randomised, parallel, placebo-controlled, multi-centre study to compare the efficacy and safety of duloxetine hydrochloride (40mg twice a day) and tolterodine tartrate (XL) (4mg once daily) with placebo in patients with symptoms of Urge Urinary Incontinence
    A.4.1Sponsor's protocol code number1208.15
    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 SponsorBoehringer Ingelheim AB
    B.1.3.4CountrySweden
    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 Information not present in EudraCT
    D.2.1.1.1Trade name YentreveAriclaim
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly BV/Boehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameYentreve
    D.3.4Pharmaceutical form Gastro-resistant capsule, hard
    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 INNduloxetine
    D.3.9.2Current sponsor codeLY248686
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Detrusitol
    D.2.1.1.2Name of the Marketing Authorisation holderPharmacia
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameDetrusitol retard
    D.3.4Pharmaceutical form Capsule, hard
    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 INNtolterodine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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
    Urge Urinary Incontinence (UUI)
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to determine the efficacy of duloxetine, 40mg twice daily compared with placebo for up to 12 weeks in women with predominant UUI, as measured by 1) the reduction in the number of incontinence episodes per week and 2) the patient’s global perception of treatment effect.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    1. To compare the effects of duloxetine with those of placebo on bladder function as measured by other parameters derived from the patient completed 1-week urinary diary
    2. To compare the effects of duloxetine with those of placebo on Patient Reported Outcomes (PRO) as measured by validated quality of life scales and symptom scores 3. To compare the effects of tolterodine, 4mg once daily with those of placebo, utilising all the efficacy measures outlined above for duloxetine, including the primary endpoints.
    4. To compare the safety of duloxetine and tolterodine with that of placebo
    5. To collect data for a future integrated analysis of two pivotal trials (1208.15 and 1208.16) on the efficacy of duloxetine compared with tolterodine during acute treatment measured by the mean change in IEF from baseline to endpoint.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Is a female outpatient 18 years of age or over.
    2. Have predominant urge urinary incontinence (UUI) defined as involuntary loss of urine immediately preceded by or accompanied by urgency (the complaint of a sudden compelling desire to pass urine, which is difficult to defer) without predominant SUI symptoms for 3 consecutive months prior to Visit 1.
    3. Predominant UUI will be defined as at least 7 UUI episodes and at least twice as many UUI as SUI episodes recorded on the Stress Urge Incontinence Questionnaire (S/UIQ) at Visit 1 AND by at least 7 urge incontinence episodes per week on the screening diary completed prior to Visit 2 (see Section 11.1).
    4. At least 10 voids per 24 hours (on a screening diary prior to Visit 2).
    5. A urine output of less than 3000mL per 24 hours, as measured and recorded on a screening frequency volume chart (prior to Visit 2).
    6.A negative cough stress test with a bladder volume of at least 150mL.
    7. Is ambulatory and able to use a toilet independently and without difficulty.
    8. Has a PVR volume less than or equal to 100mL within 15 minutes of a spontaneous void at Visit 1 documented either by ultrasound or catheterisation.
    9. Has no language or cognitive barriers, agrees to comply with the requirements of the protocol, and has signed a written informed consent document prior to any study specific examinations/interactions are performed.
    10. Have responded appropriately to all screening questions at Visit 1.
    E.4Principal exclusion criteria
    1. Pre-menopausal women (last menstruation less than 1 year prior to signing informed consent) who are:
    a. Pregnant or have been pregnant in the last 6 months
    b. Currently breastfeeding or have not resumed normal menstruation for 3 months due to breastfeeding
    c. Of child-bearing potential and are NOT practicing acceptable methods of birth control.
    2. Had continence surgery or received bladder neck bulking agent therapy, including collagen injections for incontinence, within 6 months prior to randomisation.
    3. Has a current diagnosis ureteric, bladder, urethral, or rectal fistula, uncorrected congenital abnormality leading to urinary incontinence, voiding difficulty, including significant hesitancy or history of retention.
    4.Has pelvic organ prolapse with protrusion of any vaginal segment greater than 1cm (> 1cm) beyond the hymen.
    5. Had any major surgery within 3 months prior to randomisation.
    6. Currently has, or has a history of, invasive urogenital cancer.
    7. A history of mania or bipolar disorder.
    8. Are judged clinically prior to randomisation to be at suicidal risk identified as a score of 2 or greater on question 9 of the BDI-II.
    9. Active seizure disorder.
    10. Unstable diabetes mellitus.
    11. Known neurologic lesions or conditions or local lesions (for example, bladder stones, tumours) that could cause bladder overactivity.
    12. Uncontrolled narrow angle glaucoma or a risk of acute narrow angle glaucoma.
    13. Currently has, or history of ulcerative colitis or toxic mega-colon.
    14. History of severe allergies requiring emergency medical treatment or multiple adverse drug reactions.
    15. Risk of increased bleeding or full anticoagulation.
    16. Monoamine oxidase inhibitors (MAOIs), SSRIs, SNRIs, tricyclic antidepressants or any other excluded medication intake within 14 days prior to randomisation.
    17. On a medication regimen, including diuretics, where dose and/or frequency have not been stable for at least 12 weeks prior to randomisation.
    18. Taken any medication for urge incontinence within 1 month prior to randomisation.
    19. Currently uses any anti-incontinence device including tampons used to prevent incontinence, vaginal pessaries for prolapse or incontinence.
    20. Had any nonpharmacologic intervention for incontinence or prolapse within 3 months of randomisation.
    21. Known active substance abuse disorder within the 5 years prior to randomisation or reports regular consumption of 21 or more units of alcohol per week.
    22. Any active cardiac ischaemic condition, including myocardial infarction within 6 months prior to randomisation.
    23. Uncontrolled or poorly controlled hypertension.
    24. A symptomatic arrhythmia despite antiarrhythmic medication, uncontrolled angina, or a significant abnormality on ECG
    25. Acute liver injury or severe cirrhosis (Child-Pugh Class C).
    26. Hepatic dysfunction as defined by the following laboratory parameters:
    a. SGPT (ALT) or SGOT (AST) greater than or equal to 3 times upper limit of normal (ULN)
    or
    b. Bilirubin greater than or equal to 1.5 times ULN
    27. A positive urine culture (> 100,000 cfu/mL) at Visit 1, or a history of 4 or more urinary tract infections (UTIs) in the preceding year as determined by the clinical investigator.
    28. Known severe renal impairment as defined by creatinine clearance < 30mL/min.
    29. Known hypersensitivity to duloxetine, tolterodine or any of its inactive ingredients.
    E.5 End points
    E.5.1Primary end point(s)
    • The mean change from baseline to endpoint in the number of IEF as recorded in the patient diary (The patient diary is the Subject 24-Hour Diary and frequency volume chart)
    • The Patient Global Impression of Incontinence Improvement (PGI-II) rating
    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 Information not present in EudraCT
    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) 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 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 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 No
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    End of trial is the 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 years2
    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 years2
    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 Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Information not present in EudraCT
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-02-02. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 1000
    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 Decision2005-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-03-31
    P. End of Trial
    P.End of Trial StatusCompleted
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