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    Summary
    EudraCT Number:2007-002999-34
    Sponsor's Protocol Code Number:Y-79-52120-126
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-01-07
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2007-002999-34
    A.3Full title of the trial
    A PHASE II, INTERNATIONAL, MULTI-CENTRE, PROSPECTIVE, RANDOMISED, PARALLEL-GROUP, DOUBLE-BLIND, DOSE-RANGING, PLACEBO-CONTROLLED, 12-WEEK, PRINCEPS STUDY TO ASSESS THE EFFICACY AND SAFETY OF A ONE INJECTION CYCLE WITH EITHER BOTULINUM TOXIN TYPE-A (DYSPORT 125, 250 OR 500 UNITS) OR PLACEBO FOLLOWED BY AN OPTIONAL 6-MONTH EXTENSION PHASE IN THE SYMPTOMATIC TREATMENT OF MICTURITION URGENCY AND FREQUENCY IN CONTINENT FEMALE SUBJECTS SUFFERING FROM IDIOPATHIC OVERACTIVE BLADDER
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberY-79-52120-126
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorIPSEN LIMITED
    B.1.3.4CountryUnited Kingdom
    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 Yes
    D.2.1.1.1Trade name DYSPORT*SC IM 2FL 500U
    D.2.1.1.2Name of the Marketing Authorisation holderIPSEN SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBotulinum toxin
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 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 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 placeboPowder for solution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    idiopathic overactive bladder syndrome
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level SOC
    E.1.2Classification code 10038359
    E.1.2Term Renal and urinary disorders
    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 effect of treatment with three doses of botulinum toxin type-A (Dysport) versus placebo on the number of episodes of urgency and frequency of micturition experienced in continent female subjects with idiopathic overactive bladder (iOAB) at Week 12 in comparison to Baseline.
    E.2.2Secondary objectives of the trial
    To assess the effect of three doses of Dysport versus placebo on the number of episodes of urgency, frequency of micturition, and frequency of nocturia at all assessment timepoints. To assess the severity of urgency using the Overactive Bladder Questionnaire short form (OAB-Q SF), at all assessment timepoints. To assess the effect of three doses of Dysport versus placebo on standard International Continence Society (ICS) urodynamic parameters at Week 12 and QoL over the princeps phase. Extension study objectives: To assess the duration of effect as determined by the persistence of a positive response To assess the effect of treatment on the number of episodes of urgency, frequency of micturition, and frequency of nocturia at all assessment timepoints. To assess the effect of treatment on the severity of urgency using the OAB-Q SF and QoL using the EQ-5D questionnaire at all assessment timepoints. To evaluate the safety of treatment over the extension period.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    The subject has given written informed consent to participate in the 2 phases of the study. The subject is female and aged between 18 and 75 years. The subject has a diagnosis of idiopathic overactive bladder, without incontinence. Incontinence is defined as “the complaint of any involuntary leakage of urine”. The subject has ³ 3 urgency episodes over the course of the 3 days immediately preceding the Baseline visit. Urgency is defined as “a compelling desire to pass urine that is difficult to defer” (ICS definition) The subject has ³ 24 episodes of micturition over the course of the 3 days immediately preceding the Baseline visit. The subject has failed to respond sufficiently to oral anticholinergics, or is unable to tolerate anticholinergics, as determined by the treating physician. If the subject is taking anticholinergics she must be willing to discontinue their use at screening (2 weeks before the first urodynamic investigation) and refrain from taking them for the duration of the study. The subject is able and willing to complete questionnaires and maintain accurate records on the eDiary. The subject is willing and physically able to perform ISC should it be necessary following treatment with the investigational medicinal product.
    E.4Principal exclusion criteria
    The subject has bladder outlet obstruction (on urodynamic assessment). Subject with a PMRV > 150 ml (ultrasound assessment). The subject has evidence of a urinary tract infection at Screening or Baseline in the study (detection by midstream urine dipstick analysis). The subject has nocturia due to kidney diseases and/or cardiac insufficiency. The subject has pollakiuria due to urinary tract infection or bladder tumour. The subject has active or history of interstitial cystitis, malignancy of the bladder or urothelial tract, a carcinoma in situ and/or kidney stones, or a history of any of the above. The subject is at risk of pregnancy or lactation during the study. The subject is suffering from haemostatic disorders. The subject is receiving treatment with anti-coagulation therapy at the time of injection. The subject has been diagnosed with a neuromuscular transmission disorder. The subject is receiving systemic medications that might interfere with neuromuscular transmission. The subject has a history of hypersensitivity to the investigational drug or its excipients or drugs with a similar chemical structure. The subject has previously been treated with botulinum toxin (any serotype) injections into the bladder whenever injected. The subject has been treated with botulinum toxin within 6 months before screening. The subject has been treated with any investigational drug within the last 30 days before screening. The subject has overactive bladder due to spinal cord injury, multiple sclerosis or other neurogenic cause. The subject has any conditions that interfere with mental function, such as dementia due to Alzheimer's disease, or psychosis, rendering the subject unable to understand the nature, scope and possible consequences of the study. The Subject is taking medication / substances influencing bladder function for which the dose is not anticipated to remain stable for the duration of the study. The subject has a history of pelvic radiation therapy. Subject with a history of drug or alcohol abuse. The subject has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the subject’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
    E.5 End points
    E.5.1Primary end point(s)
    Percent change in the cumulative number of episodes of urgency recorded during the three day period immediately prior to the Week 12 or early termination princeps study visit compared to the three day period prior to the Baseline visit. Percent change in the cumulative number of episodes of frequency recorded during the three day period immediately prior to the Week 12 or early termination princeps study visit compared to the three day period prior to the Baseline visit.
    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 Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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.8.3 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.8.5The 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 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 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
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers 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 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 2008-01-07. 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 301
    F.4.2.2In the whole clinical trial 301
    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 Decision2008-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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