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    Summary
    EudraCT Number:2010-024271-10
    Sponsor's Protocol Code Number:V00162GL203
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-04-21
    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 number2010-024271-10
    A.3Full title of the trial
    Urodynamic effect of one single vaginal application of 2 mL of V0162 gel (0.8%) in post-menopausal women with overactive bladder
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect on the contractions of the bladder muscle of one single vaginal application of 2 mL of V0162 gel (dosed at 0.8%) in post-menopausal women with hyperactivity of bladder function (imperious mictions).
    A.4.1Sponsor's protocol code numberV00162GL203
    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
    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 organisationPIERRE FABRE MEDICAMENT
    B.5.2Functional name of contact pointJean-Marc EDMOND
    B.5.3 Address:
    B.5.3.1Street Address45 place Abel Gance
    B.5.3.2Town/ cityBoulogne
    B.5.3.3Post code92100
    B.5.3.4CountryFrance
    B.5.4Telephone number+33534 50 62 10
    B.5.5Fax number+33534 50 65 92
    B.5.6E-mailjean.marc.edmond@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 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 nameV0162GL
    D.3.2Product code V0162GL
    D.3.4Pharmaceutical form Vaginal gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeV0162
    D.3.9.3Other descriptive named-mequitazine
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.8
    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 placeboVaginal gel
    D.8.4Route of administration of the placeboVaginal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Overactive Bladder symptoms.
    E.1.1.1Medical condition in easily understood language
    symptoms of overactive bladder such as:
    -not being able to control when you empty your bladder
    -suddenly needing to empty your bladder
    -having to empty your bladder more than usual
    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 determine urodynamic effects of one single vaginal application of 2 mL of 0.8% V0162 gel over 24 hours in post-menopausal female patients with OAB.
    E.2.2Secondary objectives of the trial
    - To evaluate the Lower urinary tract symptoms (LUTS) of one single vaginal application of 2 mL of 0.8% V0162 gel in post-menopausal female patients with OAB.
    - To evaluate clinical and biological tolerability of 2 mL of 0.8% V0162 gel in post-menopausal female patients with OAB.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Female aged 18 years and above,
    - Post-menopausal female: the postmenopause is defined as the time after which a woman has experienced twelve (12) consecutive months of amenorrhea (lack of menstruation).
    - Non neurogenic overactive bladder symptoms defined by urinary frequency (>= 8 micturitions per 24h), urgency (at least one episode per 24 hours), urgency incontinence (at least one episode of incontinence per 24h), and nocturia (at least one episode per 24h),
    - Symptoms of overactive bladder for 6 months or more,
    - Urodynamically confirmed detrusor overactivity : defined as a phasic increase in detrusor pressure of at least 5 cm of water in the presence of typical symptoms
    - Maximum urinary flow rate (Q max) >=15mL/s at randomization visit,
    - Responders to prior antimuscarinic therapy within one year,
    - Negative urine culture,
    - Patient accepting to participate in the study and able to understand and sign an approved Informed Consent Form,
    - Patient able to understand the protocol and to come to the control visits,
    - Patient who, in the judgement of the investigator is likely to be compliant during the study,
    - If required by national regulation, patient registered with a social security or health insurance system.
    E.4Principal exclusion criteria
    * Criteria related to pathologies
    - Stress incontinence diagnosed by positive cough test,
    - Total voided volume greater than 3000 ml on average per 24 hours on the two days prior to the randomization visit,
    - Concurrent urinary tract infection, urinary tract infection within 30 days of screening or history of chronic or recurrent urinary tract infections, defined as two or more episodes per year,
    - Interstitial cystitis,
    - Haematuria,
    - Current or history (within two years) of bladder neoplasm or malignancies likely to contribute to urinary dysfunction, including bladder, uterine, or cervical cancer,
    - Urinary tract calculi, urinary retention or other evidence of poor detrusor function,
    - Bladder outlet obstruction,
    - Bladder electrostimulation within 3 months before the randomization visit,
    - Bladder training therapy within 3 months before the randomization visit,
    - Intermittent self-catherization,
    - Neuropathology that could affect the lower urinary tract or its nerve supply including, but not limited to, Parkinsonism, multiple sclerosis or spinal cord injury,
    - Past history of risk of urinary retention,
    - Genital bleeding of unknown origin,
    - Current vaginal infection requiring medication,
    - Urogenital surgery within 6 months before the randomization visit,
    - Concomitant treatment with a medicinal product known to prolong the QT interval,
    - Patients with congenital long QT syndrome,
    - Patients with a known or suspected prolongation of the QT interval or an electrolyte imbalance, in particular reduced serum potassium,
    - Clinically significant bradycardia,
    - Diabetes mellitus,
    - History of severe hepatic insufficiency,
    - History of epilepsy,
    - History of closed angle glaucoma.

    * Criteria related to treatments
    - History of hypersensitivity to mequitazine or excipients (Sodium benzoate, Potassium sorbate),
    - Contraindication to anti-muscarinic treatment,
    - Anticholinergic drugs treatment within 7 days for oxybutynin, tolterodine and darifenacine, 14 days for solifenacine before the randomization visit,
    - Drugs known to prolong the QT interval, such as quinidine, amiodarone, macrolides by the IV route, or moxifloxacin,
    - History of agranulocytosis related or not to intake of other phenothiazine-derived compounds.

    * Criteria related to the population
    - History of major medical (including psychiatric) illness or surgery which, in the judgement of the investigator, puts them ‘at risk’ or is likely to modify their handling of the study drug,
    - Patient’s refusal to avoid sexual intercourse between Day1 and Day2,
    - Patients working at night
    - Participation to another clinical trial in the two previous months or during the study,
    - Patient who has forfeited her freedom by administrative or legal decision, or who is under guardianship.
    E.5 End points
    E.5.1Primary end point(s)
    The number of detrusor contractions before application and at 2 and 24 hours after one single vaginal application of V0162 gel.
    E.5.1.1Timepoint(s) of evaluation of this end point
    T0, T2h, T24h
    E.5.2Secondary end point(s)
    To evaluate the Lower urinary tract symptoms (LUTS) of one single vaginal application of 2 mL of 0.8% V0162 gel in post-menopausal female patients with OAB.
    To evaluate clinical and biological tolerability of 2 mL of 0.8% V0162 gel in post-menopausal female patients with OAB.
    E.5.2.1Timepoint(s) of evaluation of this end point
    T0, T24h
    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) 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 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 trial2
    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 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
    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 years0
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 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 state36
    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)
    usual 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 Decision2011-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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