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    Summary
    EudraCT Number:2004-001559-12
    Sponsor's Protocol Code Number:A6061024
    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:2005-07-08
    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 number2004-001559-12
    A.3Full title of the trial
    Measurement of Urethral Function in Women with Stress Urinary Incontinence - Evaluation of the Sensitivity of Urethral Reflectometry compared to Urethral Pressure Profilometry, using [S,S]-Reboxetine to detect Pharmacological Augmentation of Urethral Pressure.
    A.3.2Name or abbreviated title of the trial where available
    Not Applicable
    A.4.1Sponsor's protocol code numberA6061024
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNot Applicable
    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 SponsorPfizer
    B.1.3.4CountryDenmark
    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.2.5The 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 name[S,S]-Reboxetine Succinate
    D.3.2Product code PNU-165442G
    D.3.4Pharmaceutical form Modified-release 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 INN[S,S]–Reboxetine Succinate
    D.3.9.2Current sponsor codePNU-165442G
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 placeboModified-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
    Stress Urinary Incontinence (SUI)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.1
    E.1.2Level VTc
    E.1.2Classification code 10042213
    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 utility of urethral reflectometry in the detection of pharmacologically induced pressure changes in the female urethra.

    To compare urethral reflectometry against standard urodynamic assessment of opening and closing urethral pressure using urethral pressure profilometry (UPP) in women with SUI.
    E.2.2Secondary objectives of the trial
    To assess the effect of [S,S]-Reboxetine on urethral function in women with SUI.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
    2. Female outpatients aged 18 to 65 years.
    3. Clinically significant stress urinary incontinence (SUI) presenting either as pure SUI, or as part of mixed urinary incontinence (MUI) with predominant symptoms of SUI present.
    4. Objective evidence of SUI (without concomitant evidence of detrusor overactivity associated with urinary incontinence) as shown by either:
    - previous evidence of urodynamically proven SUI within 12 months of screening.
    - or during cystometry performed at the screening visit (as described in section
    7.7 of protocol).
    5. Subjects must be non-pregnant and non-lactating, and be either postmenopausal (greater than 1 year without menses), surgically sterilized, or using a hormonal contraceptive. (If the subject uses hormonal contraceptives (oral, injected, transdermal or implanted) they must have been using the contraceptive for ≥3 months prior to the study to ensure effectiveness and must remain on the same treatment regime throughout the entire study).
    Subjects of childbearing potential must have confirmed negative pregnancy tests prior to randomization.
    6. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, diary, and other trial procedures.
    E.4Principal exclusion criteria
    1. Symptoms of SUI < 3 months.
    2. Presence of nocturnal enuresis. (This will be calculated from the self-reported diary data collected prior to randomization).
    3. History of relevant neurological disease (e.g. multiple sclerosis).
    4. History of lower urinary tract anatomical anomaly, e.g. clinically significant (grades ≥2) urogenital prolapse.
    5. History or evidence of urinary outlet obstruction or urinary retention, including post void residual (PVR) urine volume > 50 ml (on 3 repeated measurements) at Visit 3.
    6. Chronic persistent local pathology that may cause urinary symptoms, e.g. interstitial cystitis, genitourinary tumor, bladder stone, recurrent urinary tract infection (UTI) - i.e., 3 or more UTI’s over the past 2 years.
    7. Subjects using any pharmacological agent or device for their urinary incontinence (excluding incontinence pads).
    8. Subjects with any of the following conditions:
    i) Indwelling urinary catheters or who perform Intermittent Self Catheterization (ISC).
    ii) Passive urinary incontinence (eg vesicovaginal fistula).
    iii) Not capable of independent toileting.
    9. Subjects who intend to start a bladder-training program or physiotherapy regimen during the study. Subjects on an established regimen for at least 3 months prior to study start may remain on this as long as it remains unchanged for the duration of the study.
    10. Subjects with a documented and untreated urinary tract infection (UTI) at screening. Subjects with a positive (1+ or greater) leukocyte or nitrite result in their urine dipstick test will be excluded unless a UTI can be ruled out via urine culture (please refer to section 7.12 of protocol). Subjects with a documented UTI at screening can undergo a course of treatment. Following treatment, subjects must be asymptomatic and have a repeat negative urine culture. Further participation in the study must be delayed until at least 2 weeks after successful treatment.
    11. Subjects with greater than 1+ of haematuria on dipstick test, unless fully investigated prior to randomization to rule out significant urological disease. NB: subjects who are menstruating may be re-screened once menstruation has ceased if they have been found to have haematuria on dipstick testing.
    12. History of recurrent syncope or evidence of low blood pressure (BP) (<90mmHg systolic or <40mmHg diastolic).
    13. Evidence of symptomatic postural hypotension. This includes relevant postural symptoms associated with fall in systolic BP of > 20 mmHg or diastolic BP > 10 mmHg on standing (from sitting).
    14. Subjects with a history of transient ischaemic attacks (TIA’s), stroke, or the presence of a carotid bruit (unless significant carotid stenosis (>70%) has been ruled out by appropriate investigation).
    15. Narrow angle glaucoma.
    16. Major depressive disorder (as defined by DSM-IV diagnostic criteria – see Appendix 2 of the protocol).
    17. Subjects receiving prohibited concomitant medications such as antidepressants, MAOI’s, CYP3A4 inhibitors and antimuscarinics (Further details can be found in section 5.5 of the protocol).
    18. Subjects who require systemic or topically applied Hormone Replacement Therapy (HRT) must have been using this at a stable dose for at least 3 months prior to study entry. Any change in dose or type of HRT taken during the study will be considered a protocol violation.
    19. Subjects taking any medication for an unlicensed indication.
    20. Creatinine clearance ≤ 30 ml/min (see section 7.12 of protocol).
    21. Subjects with significant hepatic impairment (moderate, i.e., Child-Pugh score of 7 to 9, and severe, i.e., Child-Pugh score of 10 to 15– see Appendix 1 of the protocol).
    22. Clinically significant abnormal 12-lead ECG taken at screening e.g. evidence of heart block or other cardiac arrhythmias (see Appendix 3 of the protocol).
    23. Malignancy within the past 2 years with the exception of basal cell carcinoma.
    24. Subjects with a history of alcohol or drug abuse in the past 2 years
    25. Subjects who are unable to swallow oral medication (tablets). Tablets are not to be crushed.
    26. Subjects who in the opinion of the investigator, or that of the Pfizer clinician, are unable and/or unlikely to comprehend the nature, scope and possible consequences of the study and to follow the study procedures and instructions and complete all study related measurements. This includes poor compliance with the trial medication, and subjects who demonstrate uncooperative behavior.
    27. Hypersensitivity to, or previous intolerance of, [S,S]-Reboxetine, racemic reboxetine, other norepinephrine re-uptake inhibitors.
    28. Intention to donate blood / blood products during the study or up to one month after completion of the study.
    29. Recent (up to 30 days or 5 x half life, whichever is longer) receipt of any other investigational drug.
    30. Subjects judged clinically to be a serious suicidal risk.
    31. Subjects who have a history of a seizure disorder.
    E.5 End points
    E.5.1Primary end point(s)
    Opening urethral pressure (Reflectometry)
    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 Yes
    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) 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 No
    E.8.1.6Cross over Yes
    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 No
    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 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 months2
    E.8.9.1In the Member State concerned days
    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) No
    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 Information not present in EudraCT
    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 2005-07-08. Yes
    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 state16
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 16
    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 Decision2005-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-07-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-06-07
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