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    Summary
    EudraCT Number:2009-017197-21
    Sponsor's Protocol Code Number:905-CL-075
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-10-05
    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 ConcernedNorway - NOMA
    A.2EudraCT number2009-017197-21
    A.3Full title of the trial
    A multicenter, open-label, single ascending dose study to evaluate pharmacokinetics, safety and tolerability of solifenacin succinate suspension in pediatric patients aged 5 to 17 years (inclusive) with Overactive Bladder (OAB)
    Protocol for Phase I Study of solifenacin succinate suspension
    Single ascending dose PK study
    A.3.2Name or abbreviated title of the trial where available
    GIRAFFE
    A.4.1Sponsor's protocol code number905-CL-075
    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 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 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 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 oral suspension 1 mg/ml
    D.3.2Product code ED905
    D.3.4Pharmaceutical form Oral suspension
    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/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) 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
    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 12.1
    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 evaluate the PK of solifenacin succinate suspension after single-dose administration at different dose levels in children and adolescents with OAB.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of solifenacin succinate suspension after single-dose administration at different dose levels in children and adolescents with OAB.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Symptoms of urgency, diagnosed as OAB according to International Children’s Continence Society (ICCS) criteria.
    2. Daytime urgency incontinence at least once/day.
    3. Patient is 5 to 11 (inclusive) or 12 to 17 (inclusive) years of age.
    4. Weight and height are within normal age percentiles (3% to 97%) according to local country standards.
    5. Patient and patient’s parent(s)/legal guardian are willing and able to comply with the study requirements and with the concomitant medication restrictions.
    6. Informed consent (patient’s parent(s)/legal guardian) has been obtained; assent (patient) where appropriate is given.
    E.4Principal exclusion criteria
    At screening:
    1. Daytime voiding frequency less than 5.
    2. Extraordinary daytime urinary frequency. Diagnosis according to ICCS definition:
    • daytime voiding frequency is at least once hourly and
    • average voided volumes are less than 50% of expected bladder capacity.
    3. Uroflow indicative of pathology other than OAB.
    4. Maximum voided volume > age expected capacity ([age +1] x 30) in ml.
    5. PVR > 10% of the functional bladder capacity.
    6. Monosymptomatic enuresis.
    7. Polyuria.
    8. Dysfunctional voiding.
    9. Congenital anomalies of the genito-urinary tract or nervous system.
    10. Current constipation (when treated the patient can enter the study).
    11. Current urinary tract infection (patient will be eligible for enrolment 14 days after a negative dipstick test, provided a second dipstick test, performed after these 14 days, is also negative).
    12. Kidney / bladder stones or other persistent local pathology that may cause urinary symptoms.
    13. Urinary indwelling catheter within 4 weeks prior to study entry.
    14. Patients with the following gastro-intestinal problems: partial or complete obstruction, decreased motility such as paralytic ileus, patients at risk of gastric retention.
    15. Any clinically significant abnormality on physical examination.
    16. Known history of QTc prolongation or risk of QT prolongation (e.g., hypokalemia,
    family history of Long QT Syndrome [LQTS]).
    17. Abnormal pulse rate (mean value) according to ranges specified below [Rijnbeek et al, 2001], judged as clinically significant by the investigator.
    - age 5-7 years: <60 beats per minute (bpm) or >110 bpm
    - age 8-11 years: <55 bpm or >100 bpm
    - age 12-17 years: <50 bpm or >100 bpm
    18. Mean systolic blood pressure greater than the 95th percentile according to age and height and/or greater than 140 mmHg, judged as clinically significant by the
    investigator; mean diastolic blood pressure greater than the 95th percentile according to age and height and/or greater than 90 mmHg, judged as clinically significant by the investigator.
    19. History or presence of any malignancy.
    20. Any clinically significant unstable medical condition or disorder, which in the opinion of the investigator precludes the patient from participating in the study.
    21. Serum creatinine more than or equal to 2 times the upper limit of normal (ULN).
    22. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than or equal to 2 times ULN, or bilirubin more than or equal to 1.5 times ULN.
    23. Any other clinically significant out of range results of urinalysis, biochemistry or
    hematology.
    24. Any clinically significant abnormality on ECG.
    25. Patient is breastfeeding, pregnant or intends to become pregnant during the study. Patients of childbearing potential who are sexually active must practice a highly reliable method of birth control (these are methods with a failure quotient of <1% per year such as hormonal implants, injectable contraceptives, oral contraceptives of combination type, intra-uterine pessaries restricted to hormone contraceptive coil, sexual abstinence or vasectomy of the partner). Note: the pregnancy test (β-HCG in serum) at screening, which is to be performed in females of childbearing potential, needs to be negative.
    26. Patient has participated in another clinical trial and/or has taken an investigational drug within 30 days (or 5 half-lives of the drug, or the limit set by national law, whichever is longer) prior to Day 1.

    At Day 1:
    33. Consumption of grapefruit, grapefruit juice or grapefruit marmalade within 14 days prior to Day 1.
    34. Positive drug screen test for drugs of abuse at Day 1.
    35. Positive alcohol breath test at Day 1.
    36. Use of prohibited prior and concomitant medication (refer to Appendix 1):
    • Anti-muscarinics, antidepressants, desmopressin or alpha-blockers within 14 days
    prior to Day 1.
    • Intravesical treatment with botulinum toxin (any history).
    • Potent cytochrome P450 (CYP) 3A4 inhibitors (e.g., ketoconazole), CYP3A4
    substrates with higher affinity (e.g., verapamil, diltiazem), or potent CYP3A4
    inducers (e.g., rifampicine, phenytoin, carbamazepine), including natural and herbal
    remedies (e.g., St. John’s Wort) within 14 days prior to Day 1.
    37. Donation of blood or blood products within 3 months prior to Day 1.
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokinetic variables:
    • Maximum concentration (Cmax)
    • Time to attain Cmax (tmax)
    • Area under the plasma concentration – time curve (AUC) from time of dosing until last measurable concentration (AUClast)
    • AUC extrapolated until time is infinity (AUCinf)
    • Apparent terminal elimination half-life (t1/2)
    • Apparent Total Body Clearance (CL/F)
    • Apparent volume of distribution during the terminal phases (Vz/F)
    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 Yes
    E.7.1.3.1Other trial type description
    Single dose PK in children and adolescents
    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 Yes
    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) 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 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 EEA10
    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 Yes
    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
    last visit, last subject
    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 Yes
    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) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-10-05. Yes
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 36
    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 Decision2010-10-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-08-14
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