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    Summary
    EudraCT Number:2016-004307-30
    Sponsor's Protocol Code Number:IXA-CSP-001
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-03-24
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2016-004307-30
    A.3Full title of the trial
    A Double-Blind, Randomised, Placebo-Controlled, Parallel Group, Phase II, Dose Ranging Trial to Evaluate the Efficacy, Safety and Tolerability of oral Litoxetine 10mg, 20mg and 40mg Twice Daily (BID) versus placebo in women with Mixed Urinary Incontinence
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and efficacy of litoxetine in women with urinary incontinence
    A.4.1Sponsor's protocol code numberIXA-CSP-001
    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 SponsorIXALTIS
    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 supportIXALTIS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIXALTIS
    B.5.2Functional name of contact pointElisabeth Svanberg
    B.5.3 Address:
    B.5.3.1Street AddressActi’Tech 6 / Archamps Technopole, 60 avenue Marie Curie
    B.5.3.2Town/ cityArchamps
    B.5.3.3Post code74160
    B.5.3.4CountryFrance
    B.5.4Telephone number+334 57 26 00 76
    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 nameLitoxetine
    D.3.2Product code Litoxetine
    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 INNLITOXETINE
    D.3.9.1CAS number 86811-09-8
    D.3.9.4EV Substance CodeSUB08536MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 nameLitoxetine
    D.3.2Product code Litoxetine
    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 INNLITOXETINE
    D.3.9.1CAS number 86811-09-8
    D.3.9.4EV Substance CodeSUB08536MIG
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mixed Urinary Incontinence
    E.1.1.1Medical condition in easily understood language
    Stress and Urge Incontinence
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    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
    To compare the efficacy of 3 doses of litoxetine (10 mg, 20 mg, 40 mg) versus placebo administered orally twice daily (BID) for 12 weeks in female subjects with a diagnosis of MUI
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of 3 doses of litoxetine (10 mg, 20 mg, 40 mg BID) compared to placebo in female subjects with a diagnosis of MUI.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Willing to provide written informed consent
    2. Have symptoms of urinary incontinence for at least 3 consecutive months
    3. Have at least 7 incontinence episodes per week in the diary entries for the Screening Period of which at least 3 episodes per week are defined as stress urinary incontinence. The PPIUS will be completed when subjects report an event in the electronic diary (e-diary)
    4. Have an Investigator-confirmed urinary leakage from the urethral meatus synchronous with effort, eg, coughing or straining as an objective evidence of the stress component of incontinence. The urge incontinence component must be confirmed by the subject diaries during the Screening Period, using the PPIUS
    5. Subject is ambulatory and able to use the toilet independently
    6. If subjects use pelvic floor exercises, subjects must have been on a stable exercise and activity regime for at least 3 months prior to Screening and that regime must remain stable during the treatment period
    7. Subject has a body mass index ≥ 19 kg/m2 but < 31 kg/m2
    8. Subjects must have a pre-dose mean systolic/diastolic blood pressure of ≤ 140/90 mmHg before randomization can occur
    9. Subjects must not be pregnant, lactating, or actively trying to become pregnant, Subjects who are premenopausal and of childbearing potential must have a negative pregnancy test at Screening (serum) and at Day 0 (urine) and must use a medically acceptable and effective method of birth control for the duration of the study, which can include:
    a. Having a male partner who is sterile prior to the female subject’s entry into the study and is the sole sexual partner for that female subject
    b. Use of double-barrier methods of contraception; condoms with the use of caps (with spermicide) and intra-uterine devices are acceptable
    c. Use of hormonal contraceptives (oral, depots, patches, etc.) with double-barrier methods of contraception as outline above
    d. True abstinence: When this is in line with the preferred and usual lifestyle of the subject (period abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
    10. Subjects taking oral contraceptives or hormone replacement therapy must have a stable dose and regimen for ≥ 3 months prior to entry into the study
    E.4Principal exclusion criteria
    1. History of anti-incontinence surgery in past 12 months
    2. Use of Botox for urge urinary incontinence in the past 12 months
    3. Grade III/IV pelvic organ prolapse; defined per clinical practice
    4. History of interstitial cystitis or bladder-related pain
    5. History of pelvic prolapse repair (cystocele or rectocele) or urethral diverticulectomy within 12 months of Screening
    6. Subjects with concurrent (at Screening), recent (within 30 days), chronic, or recurrent (> 4 per year) urinary tract infections (positive dipstick for urinary tract infection and abnormal microscopic evaluation, signs and symptoms) or unevaluated microhematuria
    7. History of diagnosed gastrointestinal obstructive disorders
    8. Chronic severe constipation
    9. History of radiation cystitis or history of pelvic irradiation
    10. Electrostimulation, biofeedback, or bladder training therapy (behavioural therapy), during the previous month prior to Screening, or the intention to initiate such therapies during the study. Pessaries and implants are also excluded.
    11. Postvoid residual (PVR) urine volume > 150 mL
    12. Diagnosis of dementia
    13. Diagnosis of epilepsy
    14. Diagnosis of acute narrow-angle glaucoma
    15. History of mania or diagnosis of bipolar disorder, and/or seizures
    16. Subjects with uncontrolled hypertension
    17. Documented history of myocardial infarction, unstable angina, and/or has undergone coronary artery bypass surgery and/or percutaneous transluminal coronary angioplasty in the past year
    18. Congestive heart failure (New York Heart Association Class III or IV heart failure
    19. Any concurrent condition or any clinically significant abnormality on the Screening physical examination, laboratory tests, electrocardiogram (ECG; including ischemic heart disease), Hepatitis B or C, which, in the opinion of the Investigator, may affect the interpretation of efficacy or safety data, or which otherwise contraindicates participation in a clinical study with litoxetine:
    a. Hypersensitivity to litoxetine or any of its ingredients
    b. History of clinically significant drug hypersensitivity
    c. Subjects with current (within 2 years) urogenital neoplasms or malignancies including bladder, uterine or cervical cancer
    d. Subjects with neuropathology that could affect the lower urinary tract or nerve supply, including but not limited to multiple sclerosis, stroke, Parkinsonism, or spinal cord injury
    e. Subjects with diabetes insipidus
    f. Clinically significant or unstable, endocrine, hepatic, renal, immunologic, or lung disease (ie, active chronic obstructive pulmonary disease, active seasonal allergic rhinitis), or malignancy other than nonmelanomatous skin cancer
    20. Severe renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73m2)
    21. Severe hepatic impairment (Child-Pugh B or greater)
    22. Subjects who are on current treatment for depression
    23. Use of the following medications: nonselective irreversible monoamineoxidase inhibitors, cytochrome P450 (CYP)1A2 inhibitors (such as fluvoxamine, ciprofloxacin, or enoxacin), pimozide and thioridazine, and any other medication that would be considered a safety risk for co-administration with litoxetine
    24. Use of any pharmacologic agent used to treat symptoms of urinary incontinence
    25. History of an addiction to drugs or alcohol within 5 years prior to Screening or of alcohol or substance abuse within the past year, as determined by the Investigator
    26. Participation in a clinical study within the month prior to Screening, or exposure to an investigational drug which has not washed out for at least 5 half-lives since the last administration prior to Screening
    27. In the opinion of the Investigator, is at risk of non-compliance with study procedures, or cannot read, understand, or complete study-related materials (including electronic diaries), particularly informed consent
    28. Participation in any clinical study of an investigational drug that may affect urinary function within 3 months prior to Screening
    E.5 End points
    E.5.1Primary end point(s)
    Percentage change from the end of the Placebo Run-in Period to Week 12 in the weekly average of number of incontinence episodes/24 hours (Number of incontinence episodes/24 hours will be computed as Total Number of incontinence episodes recorded over the 7 days/7)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    • Absolute change from the end of the Placebo Run-in Period to Week 12 in the number of incontinence episodes/24 hours
    • Dose response of study drug on the primary endpoint
    • Proportion of subjects who become continent at Week 4, Week 8, and Week 12
    • Change in the Kings Health Questionnaire total score and 3 sub-domain scores at Week 12
    • Change from end of the Placebo Run-in Period in subject’s rating of improvement using the PGI-I at Week 12
    • Change from end of the Placebo Run-in Period in PPBC score at Weeks 4, 8, and 12
    • Percentage change from end of the Placebo Run-in Period to Week 4 and Week 8 in incontinence episodes/24 hours
    • Percentage change from end of the Placebo Run-in Period to Week 4, Week 8, and Week 12 in:
    - Weekly average of number of stress incontinence episodes/24 hours
    - Weekly average of number of urge incontinence episodes/24 hours
    - Weekly average of number of micturitions/24 hours
    - Weekly average of number of nocturia episodes/24 hours
    • Proportion of subjects with at least a 50% reduction from end of the Placebo Run-in Period to Week 4, Week 8, and Week 12 in weekly average incontinence episodes/24 hours
    • Proportion of subjects with at least a 50% reduction from end of the Placebo Run-in Period to Week 12 in weekly average stress incontinence episodes/24 hours
    • Proportion of subjects with at least a 50% reduction from end of the Placebo Run-in Period to Week 12 in weekly average urge incontinence episodes/24 hours
    • Proportion of subjects with < 8 micturitions/24 hours at Week 12
    • Proportion of subjects with no urgency at Week 12
    • Proportion of subjects reporting nocturia at end of the Placebo Run-in Period with no nocturia at Week 4, Week 8, and Week 12
    • Responder analysis based on the established within-treatment minimal clinically important difference established for the Kings Health Questionnaire
    • Change from end of the Placebo Run-in Period in the number of incontinence pads used per week
    E.5.2.1Timepoint(s) of evaluation of this end point
    specified above
    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 Yes
    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 No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    2-week single-blind Run-in Period, will be followed by 12-week double blind Treatment Period
    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 trial4
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    France
    Georgia
    Poland
    Ukraine
    United Kingdom
    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
    End of trial is defined as the date of the final clinical database lock
    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 months5
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years1
    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: 190
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state38
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 240
    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
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-11-12
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