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    Summary
    EudraCT Number:2005-001627-11
    Sponsor's Protocol Code Number:617-EC-006
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-08-30
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2005-001627-11
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled study to assess the effect of Tamsulosin OCAS 0.4 mg tablets, once daily on nocturia, compared to placebo, in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia
    A.3.2Name or abbreviated title of the trial where available
    RESTORE
    A.4.1Sponsor's protocol code number617-EC-006
    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 SponsorYamanouchi Europe B.V. (to be renamed Astellas Pharma Europe B.V., as of August 2005)
    B.1.3.4CountryNetherlands
    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.2.1.1.1Trade name Omnic OCAS, prolonged release tablets (film-coated) 0.4 mg
    D.2.1.1.2Name of the Marketing Authorisation holderYamanouchi Pharma B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameTamsulosin OCAS, TOCAS
    D.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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 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 placeboProlonged-release tablet
    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
    LUTS (lower urinary tract symptoms) associated with BPH (benign prostatic hyperplasia)
    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 assess the effect of Tamsulosin OCAS 0.4 mg o.d. compared to placebo on improvement of nocturnal voiding frequency, in subjects with LUTS associated with BPH over 12 weeks.
    E.2.2Secondary objectives of the trial
    To assess the effect of Tamsulosin OCAS 0.4 mg o.d. compared to placebo, on improvement in hours of undisturbed sleep (HUS), defined as the duration of the first period of undisturbed sleep, in subjects with LUTS associated with BPH over 12 weeks.

    To compare the secondary efficacy variables and the safety/tolerability of Tamsulosin OCAS 0.4 mg and placebo.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    At study entry (visit 1):
    1. Male subject aged 45 years or over
    2. Written informed consent has been obtained
    3. Diagnosed as having LUTS associated with BPH
    4. A total I-PSS score of greater than / equal to 13
    5. A maximum urinary flow rate of greater than / equal to 4.0 mL/s and less than / equal to 12.0 mL/s, with a voided volume greater than / equal to 120 ml during free flow (a minimum of 2 flows are to be performed within 3 months of visit 1)
    6. PSA levels are within normal ranges, or if outside of normal ranges are not of clinical significance according to the investigator. A recent PSA value (determined within 3 months of visit 1) is acceptable. If a recent value is not available, a blood sample should be taken at visit 1 to determine PSA levels.
    7. On average, at least 2 voids per night over the last week
    8. A maximum of 4 hours of undisturbed sleep expected per night (night time is defined as the time from going to bed with the purpose of sleeping until waking up with the purpose of getting up)

    At randomization (visit 2):
    9. A total I-PSS score of greater than / equal to 13
    10. Compliance to run-in medication has been at least 80%
    11. Based on the sleep diary given to subject at the screening visit, on average at least 2 voids per night over 3 consecutive days (Monday-Thursday) before visit 2
    E.4Principal exclusion criteria
    At study entry (visit 1):
    1. Previous surgery to the bladder neck, prostate or pelvic region (including thermo-therapies)
    2. Previous pelvic radiation for any cause
    3. A post-voiding residual volume >250 ml by ultrasound or catheterization in at least two assessments over the last 3 months
    4. A known history or diagnosis or any of the following urinary conditions:
    a) Neurological bladder disorder (including disorders due to diabetic neuropathy)
    b) Bladder neck stenosis
    c) Stone in bladder or urethra
    d) Recurrent urinary tract infection (defined as at least two UTIs within the last 6 months)
    e) Bladder cancer (including polyposis)
    f) Prostate cancer
    g) Urethral stricture
    h) Other condition which may affect micturition (such as large bladder diverticulae)
    5. A symptomatic urinary tract infection within 1 month prior to visit 1
    6. Subject has nocturnal polyuria (defined as >33% of 24 h urine produced between 11p.m. and 7 a.m.) as determined by a 3-day frequency/volume chart completed between visit 1 and visit 2
    7. Known hepatic or renal insufficiency
    8. Alcohol consumption of more than 15 units per week (1 unit = 270 ml of beer or 40 ml of spirits or 125 ml of wine)
    9. Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to visit 1, such as myocardial infarction, uncontrolled angina, significant ventricular arrthymias, heart failure (NYHA class III/IV), orthostatic hypotension or stroke.
    10. Central nervous system conditions, such as senile dementia, multiple sclerosis, Parkinson’s Disease and psychiatric disorders.
    11. Known life-threatening diseases, such as concurrent neoplasms under treatment, AIDS/HIV
    12. Hypersensitivity to the study drug (alpha-AR-antagonists) or any of their components.
    13. Any clinical condition, which in the opinion of the investigator would not allow safe completion of the study
    14. Subject is currently taking 5alpha-reductase inhibitors or took these within the last 3 months prior to visit 1
    15. Subject is currently taking any diuretics
    16. Subject is currently taking other pharmacological treatment for BPH, such as alpha-AR-antagonists (including tamsulosin) and plant extracts, or took these within the last month prior to visit 1
    17. Subject is currently taking other drugs which may influence the pharmacodynamic effects of tamsulosin, such as combined alpha / beta-AR-antagonists, alpha-agonists, cholinergics or anti-cholinergics
    18. Subject is currently taking other investigational drugs, or took part in a clinical study within the last 3 months prior to visit 1, or took part in more than 3 clinical studies within 12 months prior to visit 1
    19. Subject is unwilling or unlikely to fulfill the study requirements in terms of visits, compliance and time commitment
    20. Subjects who work shift hours and whose hours of work include any time between 23.00 and 06.00h
    21. Employees of the sponsor, CRO or investigator site involved in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The change from baseline to week 12 in mean number of nocturnal voids measured using the sleep diary.
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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 No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Information not present in EudraCT
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 905
    F.4.2.2In the whole clinical trial 1051
    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 Decision2005-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-10-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-04-10
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