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    Summary
    EudraCT Number:2006-001334-40
    Sponsor's Protocol Code Number:PSD506-OAB-005
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-08-14
    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 ConcernedIreland - HPRA
    A.2EudraCT number2006-001334-40
    A.3Full title of the trial
    A double-blind, placebo controlled study to assess the safety and preliminary efficacy of PSD506 in treatment-naïve or previously treated (washed out) patients symptoms of overactive bladder (OAB)
    A.4.1Sponsor's protocol code numberPSD506-OAB-005
    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 SponsorPLETHORA SOLUTIONS 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 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 namePSD506
    D.3.2Product code PSD506
    D.3.4Pharmaceutical form Capsule, soft
    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.3.9.2Current sponsor codePSD506
    D.3.9.3Other descriptive nameR032-02904/000
    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 placeboCapsule, soft
    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 (OAB)
    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.1.2Term 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
    Primary Objective:

    To measure the change from baseline in average number of micturitions per day (urinary frequency)
    E.2.2Secondary objectives of the trial
    Secondary Objective(s):

    To measure the change from baseline in average number of urge urinary incontinence episodes

    To measure the change from baseline in average number of urinary urgency episodes

    To measure the change from baseline in average volume voided per micturition

    To measure the change from baseline in scores on ICIQ-FLUTS SF (International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms Short Form) or ICIQ-MLUTS SF (International Consultation on Incontinence Questionnaire-Male Lower Urinary Tract Symptoms Short Form)

    To measure the change from baseline in score on ICIQ-OABqol (International Consultation on Incontinence Questionnaire-Overactive Bladder Quality of Life)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The study population is subjects with symptoms of overactive bladder (OAB) as defined by the International Continence Society (ICS).

    Inclusion Criteria:
    1. Age 18 years or over.
    2. If female, must be surgically sterile or post-menopausal for at least a year and confirmed by a negative hormone panel (luteinizing hormone [LH], follicle stimulating hormone [FSH], 17ß estradiol. Women who are receiving HRT at the time of screening may be defined as post-menopausal provided there is documentation in their medical history to confirm that they had stopped menstruating for one year before starting the HRT.
    3. If male subject and partner is of child bearing potential must agree to use a secure form of contraception (e.g. pill, condom).
    4. Involuntary detrusor contraction associated with urgency during filling cystometry in the last 12 months prior to study entry.
    5. Symptoms of OAB for at least 6 months prior to study entry. Subjects with concurrent stress urinary incontinence (SUI) and OAB may be included provided the symptoms of OAB are dominant.
    6. Willing and able to provide written informed consent.
    Inclusion criteria at baseline:
    7. Completed appropriate washout period (for previously treated subjects) and 7 days run-in period for all subjects (both treated subjects and treatment naïve subjects) prior to Baseline Visit.
    8. Have an average of 10 micturitions and at least one episode of urinary urgency per day (during the 7 days of run-in period)
    9. Have an average of 7 episodes of urge urinary incontinence per week (during the 7 days of the run-in period)
    E.4Principal exclusion criteria
    1. Female subject who is of child-bearing potential.
    2. Uncontrolled hypertension, defined as mean systolic blood pressure [SBP] ≥160mmHg or a diastolic blood pressure [DBP] ≥95mmHg (after sitting for 5 minutes).
    3. History of clinically significant hypotensive episodes or symptoms of fainting, dizziness, or lightheadedness.
    4. Unstable cardiovascular disease, particularly coronary artery disease, arrhythmias, atrial tachycardia, or congestive heart failure.
    5. Clinically significant central nervous system disease, including: Parkinson’s disease, multiple sclerosis, transient ischemic attack, stroke, seizure disorder, depression, or behavioral disturbances.
    6. History of peripheral vascular or cerebrovascular disease.
    7. History of narrow angle glaucoma or increased ocular pressure.
    8. Clinically significant bladder pathology (e.g., obstructive uropathy) or history of urinary retention.
    9. Clinically significant gastrointestinal disorder (e.g., gastroparesis, constipation, diarrhea, colitis, gastrointestinal tract obstruction, hiatal hernia with reflux oesophagitis, cholestasis).
    10. History of clinically significant liver disease, e.g., hepatitis B.
    11. Prohibited medications taken within the previous 2 weeks prior to baseline date (4 weeks for solifenacin).
    12. Concomitant use of any agent that has a significant interaction with CYP3A4 or P glycoprotein (Pgp).
    13. Clinically significant abnormalities in laboratory test results (including hepatic and renal panels, complete blood count [CBC] and chemistry panel) at screening.
    14. Urinary tract infection within 6 weeks prior to baseline.
    15. Participation in an investigational drug or device study within 30 days prior to screening date.
    16. Known hypersensitivity to anti-cholinergic agents.
    17. Concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study; or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study. This would include, but is not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease.
    18. Unwillingness or inability to comply with the study protocol for any other reason.
    19. Unable to understand and complete the ICIQ-OABqol and ICIQ-FLUTS or ICIQ-MLUTS questionnaires or Micturition Diary.
    20. Any clinically significant abnormality on 12-lead ECG.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:
    The primary efficacy endpoint is the change from Baseline (visit 2) to Week 4 (Visit 6) in the average number of micturitions per day (urinary frequency).
    The secondary efficacy endpoints are the change from Baseline (Visit 2) to Week 4 (Visit 6) in the average number of urge urinary incontinence and urinary urgency episodes per day, average volume voided per micturition, ICIQ-OABqol and ICIQ-FLUTS SF (female subjects) or ICIQ-MLUTS SF (male subjects) scores.

    Safety:
    Adverse events, ECG (mean change in heart rate from baseline and the mean change in QTc interval from baseline), anti- muscarinic adverse events, and vital signs.

    Pharmacokinetics:
    Weekly trough level blood samples will be taken prior to dosing with study drug and at Visit 6 and the Follow-up Visit 7 (4 weeks after the last treatment dose) or an early withdrawal visit in order to further delineate the pharmacokinetics of PSD506 in human subjects.
    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 Yes
    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) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    Last follow-up visit of the 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 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 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 No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 112
    F.4.2.2In the whole clinical trial 112
    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 Decision2006-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-09-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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