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    The EU Clinical Trials Register currently displays   39188   clinical trials with a EudraCT protocol, of which   6421   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-004380-58
    Sponsor's Protocol Code Number:A3711045
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2006-12-01
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2006-004380-58
    A.3Full title of the trial
    A MULTI-CENTER, RANDOMIZED, CROSS-OVER, DOUBLE-BLIND, THIRD PARTY OPEN, PLACEBO CONTROLLED, PILOT STUDY TO ASSESS THE URODYNAMIC EFFECTS OF MODIFIED RELEASE UK-369,003 IN MEN WITH LOWER URINARY TRACT SYMPTOMS (LUTS)
    A.4.1Sponsor's protocol code numberA3711045
    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 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 nameUK-369,003
    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.3.9.1CAS number 334827-98-4
    D.3.9.3Other descriptive nameUK-369,003
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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
    Lower Urinary Tract Symptoms
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10024981
    E.1.2Term Lower urinary tract infection
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • A pilot study to assess the urodynamic changes induced by 100mg MR formulation
    of UK-369,003 vs. placebo in men with LUTS.
    • Assess the safety and tolerability of UK-369,003 in men with LUTS
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    *Male subjects, aged 40 years and above, with documented LUTS with an International Prostate Symptom Score (IPSS) ≥13 at both screening and baseline
    visit.
    *Clinical diagnosis of BPH
    *Qmax 5 to 15 ml/sec with a voided volume of >150 ml at screening visit.
    *Urodynamically defined bladder outlet obstruction based on bladder outlet obstruction index >40; calculated as PdetQmax –2Qmax and measured at visit 2
    (baseline).
    *A minimum of 50% of the patient population will also have urodynamically confirmed DO (an involuntary detrusor contraction of ≥ 10cm H2O during baseline filling cystometry and volume to first contraction ≤ 350ml)
    *Evidence of a personally signed and dated informed consent document indicating
    that the subject (or a legally acceptable representative) has been informed of all
    pertinent aspects of the trial.
    *Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures.
    E.4Principal exclusion criteria
    *History, evidence or suspicion of prostate cancer (includes total PSA value > 10 ng/ml unless prostate cancer previously excluded by biopsy)
    *Post-void residual urine volume >200 ml based on bladder ultrasound at screening
    *Documented UTI; subjects with a positive (1+ or greater) leukocyte or nitrite result in urine dipstick test will be excluded unless UTI can be ruled out via urine culture.
    *Greater than 1+ of hematuria on dipstick test, unless fully investigated prior to
    randomization to rule out significant urological disease.
    *History of relevant urological surgery or procedures that may contribute to LUTS (e.g. prostatectomy, bladder neck surgery, minimally invasive procedures of the prostate, prostatic stent insertion, pelvic irradiation, cystoscopy < 30 days prior to randomization)
    *Chronic persistent local lower urinary tract pathology (e.g. bladder neck contracture, prostatitis, bladder stone, cystitis, urethral stricture, carcinoma, large bladder diverticulum, recurrent gross hematuria).
    *Known primary neurological condition such as multiple sclerosis, Parkinson’s disease, or other neurological diseases known to affect bladder function.
    *History of catheterization for outflow obstruction in the previous 12 month (includes intermittent self-catheterization).
    *Subjects with history of difficult catheterization.
    *Subjects receiving or who are likely to receive during the study any of the medications:
    • α-blockers, muscarinic receptor antagonists, PDE5 inhibitors, and agents known to affect vesico-urethral function.
    • 5-α-RIs
    • Diuretics, beta-blockers or other anti-hypertensive agents
    • Nitrates or nitric oxide donors in any form on either regular or intermittent basis (oral, sublingual, buccal, transdermal, inhalation or aerosols).
    • Potent CYP3A4 inhibitors
    • Topical agents are permitted.
    • Warfarin.
    *Significant allergy to or known hypersensitivity or intolerance to PDE5 inhibitors.
    *Increased susceptibility to vasodilators including those with left ventricular
    outflow obstruction (e.g., hypertrophic obstructive cardiomyopathy)
    *Poorly controlled type I or type II diabetes mellitus as defined by Hemoglobin
    A1C >7%.
    *Loss of vision in one eye due to non-arteritic ischemic optic neuropathy (NAION) regardless of whether or not this event was temporarily associated with the use of a PDE5 inhibitor.
    *Hereditary degenerative retinal disorders (e.g. retinitis pigmentosa).
    *History of recurrent syncope or evidence of low blood pressure (BP) (<90mmHg systolic or <40mmHg diastolic) or 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.
    *Any relevant clinically significant abnormalities on the screening physical examination or laboratory tests including patients with moderate liver function
    tests abnormalities (>1.5 x upper limit of normal) and renal function abnormalities (serum creatinine ≥2.5 mg/dl or ≥220 µmol/l).
    *Family history of prolonged QT syndrome or who themselves have a QTc of >450msec at the screening visit as measured by a 12-lead supine ECG.
    *Risk of priapism e.g. sickle cell disease, multiple myeloma and myeloproliferative disorders (e.g. myeloid leukemia, polycythemia, thrombocythemia).
    *Subjects currently experiencing any clinically significant or unstable medical condition that might limit their ability to complete the study, or to comply with
    the requirements of the protocol, including: dermatologic disease, hematological
    disease, pulmonary disease, renal disease, hepatic disease, gastrointestinal disease, genitourinary disease, endocrine disease, neurological disease and psychiatric disease. Significant cardiovascular disease, including congestive heart failure, myocardial infarction, unstable angina, stroke, symptomatic or clinically significant cardiac arrhythmia in the last 6 months is also an exclusion criterion
    *Any malignancy not considered cured (except basal cell carcinoma of the skin).
    A subject is considered cured if there has been no evidence of cancer recurrence
    for the 5 years prior to screening. History of bladder or prostate cancer is an exclusion criterion regardless of status.
    *Blood donation 4 weeks prior to screening, or stated intention to donate blood or
    blood products during the period of the study or within one month following completion of the study.
    *Subjects who, in the opinion of the investigator, abuse alcohol or drugs, are not
    likely to complete the study for whatever reason, or who are unable or unwilling
    to consistently and accurately complete the diary and answer the required questionnaires.
    *Subjects who have received any investigational drug during the preceding 30 days or five times the plasma half life (if known), whichever is longer.
    E.5 End points
    E.5.1Primary end point(s)
    The following urodynamic parameters/assessments will be used to assess the treatment efficacy:
    • Change from baseline in Pdet, Qmax (detrusor pressure at maximum flow rate)
    • Change from baseline in Qmax
    • Change from baseline in Cystometric capacity
    • Change from baseline in post-void residual urine volume (PVR)
    • Change from baseline in Qave (average flow rate = volume voided/flow time)
    • Change from baseline in volume at first unstable contraction
    • Change from baseline in average detrusor pressure during micturition
    Subjects will be asked to complete the “one week” version of the IPSS at Screening,
    prior to each treatment period and end of each treatment period.
    From the IPSS, the following endpoints will be derived and analyzed:
    • the change in the IPSS total score: sum of the IPSS questions 1-7;
    • the change in the IPSS storage subscore: sum of the IPSS questions 2, 4 and 7;
    • the change in the IPSS voiding subscore: sum of the IPSS questions 1, 3, 5 and 6.
    Where the change will be calculated as the difference in the specified score between thebaseline and end of treatment for each period.
    • Change from baseline in BOOI (bladder outlet obstruction index= Pdet,Qmax –2Qmax; formerly the AG number)
    • Change from baseline in BCI (bladder contractility index= Pdet,Qmax +5Qmax)
    • Change from baseline in BE (Bladder voiding efficiency= (Voided volume/total
    bladder capacity) X 100)
    The change from baseline for each endpoint during each period will be calculated by
    using the baseline value for that endpoint that was measured prior to period.
    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 Yes
    E.6.5Efficacy Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    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 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
    End of Trial in a Member State of the European Union is defined as the time at which it is deemed that sufficient subjects have been recruited and completed the trial as stated in the regulatory application and ethics application in the Member State.
    End of Trial in all participating countries is defined as Last Subject Last Visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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 years2
    E.8.9.2In all countries concerned by the trial months6
    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 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 No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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 Decision2006-12-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-15
    P. End of Trial
    P.End of Trial StatusOngoing
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