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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2008-005215-17
    Sponsor's Protocol Code Number:905-EC-007
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-08-03
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2008-005215-17
    A.3Full title of the trial
    A Study to Evaluate the Overall Effect of Solifenacin 5mg and 10mg on Bladder Wall Thickness and urinary Nerve Growth Factor in Female Subjects with Overactive Bladder and a Diagnosis of Detrusor Overactivity – A double-blind, randomized, placebo-controlled, parallel group, multicentre study
    A.3.2Name or abbreviated title of the trial where available
    SHRINK
    A.4.1Sponsor's protocol code number905-EC-007
    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 SponsorAstellas Pharma Europe 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 Vesicare
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma US Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 Film-coated 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.3.8INN - Proposed INNSOLIFENACIN
    D.3.9.1CAS number 242478-38-2
    D.3.9.2Current sponsor codeYM905
    D.3.9.3Other descriptive nameSOLIFENACIN SUCCINATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 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 placeboFilm-coated 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
    Overactive bladder
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    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
    1. To evaluate the effect of solifenacin versus placebo on bladder wall thickness (BWT) after 12 weeks of treatment.
    2. To evaluate the effect of solifenacin versus placebo on urinary Nerve Growth Factor (uNGF) normalized by urine creatinine level (uNGF/Cr) after 12 weeks of treatment in subjects with uNGF above laboratory quantification limit at baseline.
    E.2.2Secondary objectives of the trial
    1. To evaluate the effect on bladder wall thickness (BWT) of
    a. Solifenacin versus placebo after six (6) weeks of treatment.
    b. 5mg and 10mg of solifenacin (dose response).
    2. To evaluate the relationship of bladder wall thickness (BWT) and
    a. OAB symptoms at baseline and changes observed during the study.
    b. Changes observed in subject perceived satisfaction scales.
    3. To evaluate the effect on urinary nerve growth factor (uNGF) / creatinine (Cr) of
    a. Solifenacin versus placebo after six (6) weeks of treatment.
    b. 5mg and 10mg of solifenacin (dose response).
    4. To evaluate the relationship of urinary nerve growth factor (uNGF) / creatinine (Cr) and
    a. OAB symptoms at baseline and changes observed during the study.
    b. Changes observed in subject perceived satisfaction scales.
    5. To evaluate the relationship between bladder wall thickness (BWT) and urinary nerve growth factor (uNGF) / creatinine (Cr).
    6. To evaluate the safety and tolerability of 5mg and 10mg solifenacin.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject is eligible for the study if all of the following apply:
    1. The subject should be female aged greater than or equal to 18 years of age.
    2. The subject should have symptoms of overactive bladder (OAB), including urinary frequency, urgency or urge incontinence, for greater than or equal to 3 months.
    3. The subject should have an urodynamic diagnosis of detrusor overactivity (DO).
    4. The subject should be either naïve to anti-muscarinic treatment (i.e. no prior history of use of antimuscarinic agents) or 6-months anti-muscarinic treatment free i.e. have had no anti-muscarinic treatment within 6 months) prior to the screening visit.
    5. The subject should have a bladder post-void residual volume of less than 30ml.
    6. The subject has provided Independent Ethics Committee (IEC)-approved written informed consent and privacy language as per national regulations (e.g., HIPAA Authorization for U.S. sites) prior to any study-related procedures.
    7. The subject is available to complete the study.
    E.4Principal exclusion criteria
    Subject will be excluded from participation if any of the following apply:
    1. The subject has a history of stress urinary incontinence, uretheral sphincter incompetence or neurogenic detrusor overactivity.
    2. The subject has a history, signs or symptoms suggestive of urinary tract infection (confirmed by positive urine analysis), obstruction or urogenital pro-lapse (greater than grade II).
    3. The subject has a history of urinary tract operation within 6 months prior to screening.
    4. The subject has an indwelling catheter or permanent catheter fitted.
    5. The subject has a history of pelvic area radiotherapy treatment.
    6. The subject has uncontrolled diabetes mellitus.
    7. The subject has a history of fibromyalgia.
    8. The subject is post-partum or breast-feeding within 3 months prior to screening visit.
    9. The subject is either pregnant or intends to become pregnant during the study or sexually active, of childbearing potential and is unwilling to utilize a reliable method of birth control such as implants, injectables, combined oral contraceptives, some IUDs sexual abstinence or vasectomized partner.
    10. The subject has a positive pre–study hepatitis B surface antigen, hepatitis C antibody or HIV result at time of screening.
    11. The subject has a history of drug and / or alcohol abuse at time of screening.
    12. The subject has a history of known or suspected hypersensitivity to solifenacin succinate, oxybutynin hydrochloride, other anti-cholinergics or lactose, to any component of the dosage form or any other allergy, which, in the opinion of the Investigator, contraindicates their participation.
    13. The subject has a history of urinary retention, severe gastrointestinal obstruction (including paralytic ileus or intestinal atony or toxic megacolon or severe ulcerative colitis), myasthenia gravis, uncontrolled narrow angle glaucoma or shallow anterior chamber or deemed to be at risk for these conditions.
    14. The subject is undergoing hemodialysis or has severe renal impairment (creatinine clearance =< 30 ml/ min) or moderate hepatic impairment. Subjects who are on treatment with a potent CYP3A4 inhibitor, e.g. Ketoconazole will also be excluded. (Prior to randomization at least one actual serum creatinine value should be available to calculate creatinine clearance according to MDRD / Cockroft Gault.)
    15. The subject has started or had any dose(s) changes of medication, described in the list in appendix 1B (list of medications permitted with restrictions), within 1 month prior to screening, which will interfere with the study procedures or compromise safety.
    16. The subject is currently dosing with medication(s) intended to treat overactive bladder symptoms or has a history of non-drug treatment, such as electrical therapy, magnetic field stimulation, pelvic floor treatment or bladder training intended to treat overactive bladder symptoms within 6 months prior to screening, as described in the list in appendix 1A (list of prohibited medications).
    17. The subject is currently receiving or has a history of treatment with alpha blockers, botulinum toxin (cosmetic use is acceptable), resiniferatoxin or pelvic floor muscle relaxants within 9 months prior to screening, as described in the list in appendix 1A (list of prohibited medications)
    18. The subject has any clinically significant abnormality following Investigator review of the physical examination which, in the opinion of the Investigator, contraindicates her participation.
    19. The subject has any clinically significant abnormal heart rate or blood pressure measurements, at the screening visit, which, in the opinion of the Investigator, prevent safe participation in the study.
    20. The subject, in the opinion of the investigator, may find it difficult to adhere to the provisions of treatment and observation specified in the protocol such as the subject diary.
    21. The subject has participated in any clinical study less than or equal to 3 months prior to screening.
    22. The subject has any clinical condition, diagnosis, symptomatology or ongoing investigation, which, in the opinion of the Investigator, contraindicates their participation.
    23. The subject is an employee of Astellas Pharma or any other third party related to the study site.
    E.5 End points
    E.5.1Primary end point(s)
    1. Change from baseline to week 12 LOCF in bladder wall thickness measured with TVUS.
    2. Value at week 12 LOCF in urinary nerve growth factor / creatinine.
    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 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.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA78
    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 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
    The end of the study is defined as the last subject completing the last protocol defined visit (end of study visit).
    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 months4
    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 months4
    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.1.3Elderly (>=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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 583
    F.4.2.2In the whole clinical trial 639
    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 Decision2009-09-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-06-23
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