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    The EU Clinical Trials Register currently displays   43841   clinical trials with a EudraCT protocol, of which   7281   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:2011-000250-28
    Sponsor's Protocol Code Number:905-CL-079
    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:2011-09-27
    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 number2011-000250-28
    A.3Full title of the trial
    A Multicenter, Open-label, Single-dose Study to Evaluate Pharmacokinetics, Safety and Tolerability of Solifenacin Succinate Suspension in Pediatric Subjects from 5 to less than 18 years of age with Neurogenic Detrusor Overactivity (NDO)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this study is to evaluate blood levels of solifenacin succinate (the study drug) in children after taking a single oral dose.
    A.3.2Name or abbreviated title of the trial where available
    SINGLE DOSE STUDY TO MEASURE BLOOD LEVELS AND SAFETY OF A DRUG FOR CHILDREN WITH OVERACTIVE BLADDER
    A.4.1Sponsor's protocol code number905-CL-079
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01539707
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstellas Pharma Europe B.V.
    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 supportAstellas Pharma Europe B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Europe B.V.
    B.5.2Functional name of contact pointService Desk - Global Development O
    B.5.3 Address:
    B.5.3.1Street AddressElisabethhof 19
    B.5.3.2Town/ cityLeiderdorp
    B.5.3.3Post code2352 EW
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31715 455 878
    B.5.5Fax number31715 455 224
    B.5.6E-mailcontact@nl.astellas.com
    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 No
    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 nameSolifenacin Succinate
    D.3.2Product code YM905
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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 242478-38-2
    D.3.9.2Current sponsor codeYM905
    D.3.9.3Other descriptive nameSOLIFENACIN SUCCINATE
    D.3.9.4EV Substance CodeSUB21028
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Neurogenic Detrusor Overactivity (NDO)
    E.1.1.1Medical condition in easily understood language
    NDO is defined as detrusor overactivity when there is a relevant neurologic condition. Overactive detrusor function is characterized by involuntary detrusor contractions during the filling phase.

    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10012547
    E.1.2Term Detrusor hyperreflexia
    E.1.2System Organ Class 10038359 - 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 evaluate the pharmacokinetics of solifenacin succinate suspension after single-dose administration in children and adolescents with NDO.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of solifenacin succinate suspension after single-dose administration in children and adolescents with NDO.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    At screening:
    1. Subject is male or female from 5 to less than 18 years of age.
    2. Documented diagnosis of NDO, confirmed by urodynamics.
    3. Weight and height are within normal percentiles (3rd to 97th percentile) according to Centers for Disease Control and Prevention (CDC) growth charts.
    4. Subject’s bowel function is being actively managed.
    5. Able to swallow the study medication in accordance to the protocol.
    6. Female subjects of childbearing potential and sexually active agree to use a reliable form of birth control for the duration of the study and for at least one month after ending study treatment. Sexually active male subjects agree to use a barrier method of birth control for the duration of the study and for at least one month after ending study treatment.
    7. Subject and subject’s parent(s)/legal guardian are willing and able to comply with the study requirements and with the concomitant medication restrictions.
    8. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations (e.g., HIPAA Authorization for U.S. sites) must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable). In the case of a minor, consent from a parent or guardian must be obtained. In the case of an adolescent, a written assent to participate may also be required per local IRB/IEC rules.
    E.4Principal exclusion criteria
    At screening:
    1. Subject is breastfeeding or pregnant. Subjects of childbearing potential must have a negative serum pregnancy test.
    2. Subject with any of the following gastrointestinal (GI)conditions: partial or complete bowel obstruction, decreased motility (e.g., paralytic ileus) or at risk for gastric retention.
    3. Current fecal impaction or history of hospitalization for fecal impaction with enema in the past 2 years.
    4. Subject has a QTcB interval greater than 440 ms, a history of QTc prolongation or at risk of QT prolongation (e.g., hypokalemia, Long QT Syndrome [LQTS] as can be suspected in case of a family history or exercise induced syncope).
    5. Any clinically significant abnormality on ECG.
    6. Any clinically significant or unstable medical condition or disorder which, in the opinion of the investigator, precludes the subject from participating in the study.
    7. History or current diagnosis of any malignancy.
    8. Diagnosis of central or X chromosome-linked diabetes insipidus.
    9. Subject has severe renal impairment (glomerular filtration rate <30ml/min).
    10. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is greater than or equal to 2 times the ULN or total bilirubin greater than or equal to 1.5 times the ULN.
    11. Any other clinically significant out of range results of urinalysis, biochemistry or hematology.
    12. Known or suspected hypersensitivity to solifenacin (or other anticholinergics), any of the excipients used in the current formulation or previous severe hypersensitivity to any drug.
    13. Subject has participated in another clinical trial and/or has taken an investigational drug within 30 days (or 5 half-lives of the drug whichever is longer) prior to Day 1.
    14. Requires ongoing treatment with any of the following prohibited medications: antimuscarinic therapy, tricyclic/tetracyclic antidepressants, H1 antihistamines, strong CYP3A4 inhibitors, strong CYP3A4 inducers (many antiepileptic drugs like carbamazepine, phenytoin and phenobarbital).
    15. Mean systolic blood pressure greater than the 95th percentile according to age and height and/or greater than 140 mmHg [National Institute of Health, 2005], judged as clinically significant by the investigator.
    16. Subject’s parent(s)/legal guardian is an employee of the Astellas Group, the Contract Research Organization (CRO) involved, or the investigator site executing the study.
    17. Subject has a history of glaucoma.
    At Day 1:
    1. Consumption of grapefruit and products made of it (e.g., juice), and Seville oranges and products made of it (e.g., marmalade) within 14 days prior to Day 1.
    2. Positive drug screen test for drugs of abuse at Day 1.
    3. Positive alcohol breath test at Day 1.
    4. Use of prohibited prior and concomitant medication:
    • Antimuscarinics, tricyclic/tetracyclic antidepressants, H1 antihistamines within 5 half-lives prior to intake of study drug at Day 1
    • Prescribed or over the counter (OTC) drugs that are potent cytochrome P450 (CYP) 3A4 inhibitors (e.g., ketoconazole), CYP3A4 substrates with higher affinity (e.g., verapamil, diltiazem), or potent CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine), including natural and herbal remedies (e.g., St. John’s Wort) within 14 days prior to intake of study drug at Day 1.
    5. Donation of blood or blood products within 3 months prior to Day 1.
    6. Positive urine pregnancy test.
    E.5 End points
    E.5.1Primary end point(s)
    - Maximum concentration (C max)
    - Time to attain C max (T max)
    - Area under the plasma concentration – time curve (AUC) from time of dosing until last measurable concentration (AUC last)- only if non-compartmental approach is used to analyze the data
    - AUC extrapolated until time is infinity (AUC inf)
    - Apparent terminal elimination half-life (t 1/2)
    - Apparent Total Body Clearance (CL/F)
    - Apparent volume of distribution during the terminal phases (Vz/F)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At each study visit (Day 1, Day 3, Day 5 and Day 7)
    E.5.2Secondary end point(s)
    AEs, clinical laboratory evaluations (hematology, biochemistry, urinalysis), vital signs, ECG and physical examination
    E.5.2.1Timepoint(s) of evaluation of this end point
    At each study visit (Day 1, Day 3, Day 5 and Day 7)
    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 No
    E.6.6Pharmacokinetic Yes
    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) Yes
    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
    pediatric phase I trial
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Canada
    Denmark
    Netherlands
    Poland
    Turkey
    United Kingdom
    United States
    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 last subject’s last protocol-defined assessment will mark the end of the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    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 Yes
    F.1.1Number of subjects for this age range: 12
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 6
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 6
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects include children and adolescents aged 5 years - 17 years (inclusive). Next to Information Sheets and Consent Forms /Assent forms for patients, also Parent/Legal Guardian Information Sheets and Consent forms will be prepared.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 12
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Standard of care
    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 Decision2011-10-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-08-13
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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