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    Summary
    EudraCT Number:2005-005457-22
    Sponsor's Protocol Code Number:TA-5538-03
    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:2006-02-06
    Trial 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 number2005-005457-22
    A.3Full title of the trial
    A phase IIa, multi-centre, randomised, placebo-controlled, double-blind, parallel group study of TA-5538, in patients with overactive bladder
    A.4.1Sponsor's protocol code numberTA-5538-03
    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 SponsorTanabe Seiyaku Co., Ltd
    B.1.3.4CountryJapan
    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.2.5The 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 nameTA-5538
    D.3.2Product code TA-5538
    D.3.4Pharmaceutical form Tablet
    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.3.9.1CAS number 629921-36-4
    D.3.9.2Current sponsor codeTA-5538
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 nameTA-5538
    D.3.2Product code TA-5538
    D.3.4Pharmaceutical form Tablet
    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.3.9.1CAS number 629921-36-4
    D.3.9.2Current sponsor codeTA-5538
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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 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 placeboTablet
    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
    A phase IIa, multi-centre, randomised, placebo-controlled, double-blind, parallel group study of TA-5538, in patients with overactive bladder
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10059617
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of TA-5538, 50 mg b.i.d and 150 mg b.i.d, versus placebo b.i.d., during a 4 week treatment period, in patients with symptoms of overactive bladder (OAB).
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of TA-5538.

    To evaluate the population pharmacokinetics (PPK) of TA-5538.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Eligible patients will meet ALL of the following criteria:
    - Males or females (females must not be of childbearing potential, i.e. postmenopausal for at least one year or surgically sterile). Males must be vasectomised or must use reliable contraceptives during the study period.
    - Aged 18-75 years inclusive.
    - Patients must exhibit all of the following symptoms of OAB during the last week of the 2 week placebo run-in period (this information will be collected using a patient diary):
    frequency of micturition - at least 8 voids per day on average, over 3 days.
    urgency incontinence - at least 2 episodes per day on average, over 3 days.
    - Patients must have had symptoms of OAB for ≥ 6 months.
    E.4Principal exclusion criteria
    Patients will be ineligible for this study based on ANY ONE of the following criteria:
    - Patients with stress or mixed incontinence where the predominant component is the stress, as assessed by the investigator (symptoms or stress test)
    - Patients with a known neurological disease which is thought to affect the bladder.
    - Male patients with significant outlet obstruction (flow rate: ≤ 12mL/sec).
    - Patients with a post void residual (PVR) volume of urine > 150mL.
    - Patients with a urine mean volume more than 2.5 L per day.
    - Patients with bladder stones.
    - Patients with active or recurrent urinary tract infection (UTI). Evidence of UTI at screening , or unexpected haematuria will prevent patients from entering the study until this matter is clinically resolved.
    - Patients with painful bladder syndrome/bladder pain.
    - Patients with malignancy, except squamous cell carcinoma (skin cancer).
    - Patients with known fibroids.
    - Ongoing treatment with any of the following medications or treatment within 2 weeks prior to the placebo run-in period (Week -2 Visit):
    antichloinergic/antispasmodic drugs (such as oxybutynin, tolterodine, solifenacin, darifenacin, hyoscyamine, propantheline, trospium or flavoxate)
    diuretics
    other drugs with significant anticholinergic effects (such as imipramine and most other tricyclic antidepressants, however mianserin and trazodone are permitted)
    drugs that significantly inhibit CYPs (such as ritonavir, sachinavir, itoconazole, ketoconazole, troleandomycin, miconazole, nefazodone mibefradil, clarithromycin, glibenclamide, clotrimazole)
    -Hormone replacement therapy (estrogens) if taken less than 3 months before the placebo run-in period (Week -2 visit).
    -Patients on long term stable-dose treatment with other drugs are not excluded as long as treatment remains stable during the study.
    -Evidence of hepatic disease (AST (SGOT), or ALT (SGPT), or total bilirubin > 1.5 x upper limit of normal, or ALP > 1.2 x upper limit of normal); other abnormalities in screening laboratory tests which in the judgement of the investigator and/or sponsor clinician would interfere with the patient's participation in the study.
    -Patients with cystocoele beyond the hymen and patients with significant symptomatic prolapse.
    - Patients who have undergone urogenital surgery.
    - Patients with other clinically significant systemic diseases.
    - Patients who intend to start a bladder training programme while in the study. Patients on such a programme at study entry may not modify or discontinue their bladder training during the course of the study.
    - Patients with an indwelling catheter and patients practicing intermittent self-cathererisation.
    - Patients who have received any investigational drug during the preceding 12 weeks prior to the placebo run-in period (Week -2 visit).
    - Patients who in the opinion of the investigator, or that of sponsor's clinician, are unable and/or unlikely to comprehend and follow the study procedures and instructions.
    - Patients who are abusers of alcohol and/or other drugs.
    - Patients who intend to donate blood or blood products during the study or within one month following the completion of the study.
    - Patients with history of any clinically significant drug allergy.
    - Patients not capable of independent toileting.
    - Patients not capable of independentlty completing the patient diary.
    - Patients not willing to give informed consent by signing and dating an informed consent form prior to study entry.
    E.5 End points
    E.5.1Primary end point(s)
    Mean number of micturitions per day.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) 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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    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.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 225
    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 Decision2006-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-01-18
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