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    Summary
    EudraCT Number:2006-000833-36
    Sponsor's Protocol Code Number:STH14330
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-04-17
    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 ConcernedUK - MHRA
    A.2EudraCT number2006-000833-36
    A.3Full title of the trial
    The Action of Botox® on Urgency – A precise evaluation of its impact on urodynamic parameters during bladder filling in patients with non-neurogenic Overactive Bladder (OAB).
    A.4.1Sponsor's protocol code numberSTH14330
    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 SponsorSheffield Teaching Hospitals NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 BOTOX
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 IMPIntravesical use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNClostridium botulinum serotype A neurotoxin
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100 U/ml
    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 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 typeClostridium botulinum type A neurotoxin complex
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non-neurogenic Overactive Bladder (OAB)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10059617
    E.1.2Term Overactive bladder
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To quantify the action of botulinum toxin serotype-A (BOTOX) on urgency using a novel electronic measurement device.
    E.2.2Secondary objectives of the trial
    To quantify the action of botulinum toxin serotype-A (BOTOX) on a number of secondary end-points including quality of life, urinary frequency and voided volume and urodynamic parameters measured using ambulatory urodynamics.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Previous use of botulinum toxin Type A

    Outpatient, male or female subjects, of any race, between 21 and 75 years of age.

    Subjects with a non-neurogenic bladder and detrusor overactivity

    Subjects with urinary incontinence (minimum of one occurrence per day). [NOTE: Bladder emptying may be accomplished with straining, intermittent catheterization (IC), spontaneous micturition or leakage episodes.]

    Subject has urge urinary incontinence on 3 day bladder diary as defined by urinary leakage associated with common triggers of urge leakage such as “key in the door”, running to the bathroom, standing up, running water, etc.

    Subject has severe incontinence as defined below:
    1) Mean # of daily leakage episodes ≥ 1/day documented on 3 day bladder diary
    2) Mean # of voids ≥ 8/day documented on 3 day bladder diary

    Laboratory findings required
    1)Urine dipstick or urine culture negative for urinary tract infection
    2)Post void residual volume <150 cc

    Ability to follow study instructions and likely to complete all required visits

    A willingness and ability to perform intermittent clean catheterization

    Subjects able to understand the requirements of the study, including completing questionnaires and signing Informed Consent
    E.4Principal exclusion criteria
    Patients not previously exposed to botulinum toxin type A

    Use of botulinum toxin type A within previous 6 months

    Female subjects who are pregnant (positive urine pregnancy test) or of childbearing age who are not taking suitable contraceptive precautions.

    Subjects with a history of transurethral sphincterotomy, bladder neck or prostatic resection, previous bladder surgery including myomectomy or augmentation cystoplasty.

    Subjects with chronic indwelling catheters.

    Subjects with any medical condition that may increase their risk of exposure to botulinum toxin including diagnosed myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis or any other disease that might interfere with neuromuscular function.

    Subjects with an allergy or sensitivity to any component of BOTOX®

    Subjects unable to discontinue any agents that might interfere with neuromuscular function (i.e., aminoglycoside antibiotics, curare-like agents, etc.).

    Subjects with, in the opinion of the Investigator, unstable multiple sclerosis.

    Subjects with known, uncontrolled systemic disease.

    Subjects with evidence of recent alcohol/drug abuse.

    Subjects who, in the opinion of the Investigator, have a significant condition or situation that may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.

    Subjects with a history of poor cooperation, non-compliance, or unreliability.

    Subjects currently participating in an investigational drug study or who have participated in an investigational drug study within 30 days of the Baseline Visit.

    History of carcinoma of the bladder

    Presence of a foreign body in the bladder, cystitis or other correctable aetiology for urgency urinary incontinence.

    Gross fecal incontinence (due to confounding effects on pad weights and counts)

    Clear evidence of emptying phase or detrusor dysfunction that may put the subject at risk for urinary retention

    Known allergy to Ciprofloxacin (used for urinary tract infection prophylaxis) or to lidocaine or related compounds (used for local analgesia)

    Prior documented resistance to Botox®
    E.5 End points
    E.5.1Primary end point(s)
    a)We hypothesise that Botox® will significantly decrease the frequency of urgency and increase the warning time, refractory (urgency free) time and intervoid interval (primary end points).
    b)We Hypothesise that Botox® will cause statistically significant alterations in urinary frequency, voided volume and quality of life (secondary end points).
    c)We Hypothesise that Botox® will decrease the duration, amplitude and frequency of overactive detrusor contractions measured on ambulatory urodynamics (secondary end points).
    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 No
    E.6.5Efficacy No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 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
    Close out visit for patients will be 6 months post treatment
    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 months0
    E.8.9.1In the Member State concerned days0
    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 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 Yes
    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 state14
    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 Decision2007-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-07-01
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