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    Summary
    EudraCT Number:2008-004861-25
    Sponsor's Protocol Code Number:A4091019
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-03-17
    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 ConcernedFrance - ANSM
    A.2EudraCT number2008-004861-25
    A.3Full title of the trial
    A PHASE 2, 16 WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED, PARALLEL GROUP PROOF-OF-CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF PAIN ASSOCIATED WITH CHRONIC ABACTERIAL PROSTATITIS
    A.4.1Sponsor's protocol code numberA4091019
    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 Ltd., Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK
    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 nameTanezumab
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 880266-57-9
    D.3.9.2Current sponsor codePF-04383119
    D.3.9.3Other descriptive nameRN624, RI624
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Abacterial Prostatitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10009109
    E.1.2Term Chronic prostatitis
    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 efficacy, safety and tolerability of a single intravenous infusion of tanezumab in the treatment of pain associated with chronic prostatitis.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of a single dose of tanezumab in the treatment of other symptoms (eg, urinary urgency and frequency) associated with chronic prostatitis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    Assessment 1 (Screening). The following inclusion criteria have to be met in order for a subject to be randomized in this trial:
    1. 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.
    2. Male outpatients aged ≥18 years.
    3. Weight is ≤160 kg or a body mass index (BMI) of ≤39 kg/m2.
    4. Clinical diagnosis of chronic abacterial prostatitis or chronic pelvic pain syndrome.
    5. Moderate to severe chronic prostatitis at Screening as defined by:
    CPSI - Evidence of severity of CP - Total score ≥15
    4-Glass Test - Type III prostatitis - No evidence of bacterial infection by standard microbiology within 2 years of screening
    An attempted 4-glass culture should have been performed within 2 years of Screening, with accompanying documentary evidence, or it will need to be repeated at Screening. If a urinary tract infection (UTI) has occurred in the period since the 4-glass culture was performed, then the 4-glass culture will need to be repeated again at Screening. It is recognized that it may not have been possible to collect both VB1 and VB2 or Expressed Prostatic Secretions (EPS). However, evidence must be available to categorize into types IIIa and IIIb chronic abacterial prostatitis.
    See also exclusion criterion #6, which excludes bacterial cystitis within 6 weeks.

    6. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, the self-completion of study questionnaires and symptom diaries, and other trial procedures.
    7. Male patients must agree that they and their female spouses / partners will use adequate contraception (2 forms of birth control, one of which must be a barrier method) or be of non-childbearing potential. They must be willing to use approved methods of contraception from commencement of screening procedures until 16 weeks after last dose of study medication.
    Assessment 2 (Randomization). The following continuation criteria have to be met in order for subjects to be randomized:
    8. Completes at least 4 diary days during the 7 days prior to randomization, with a mean average pain intensity score of ≥4 (0-10 NRS); the mean average pain intensity score is defined as the mean of all 24 hr pain intensity scores recorded in the 7-day period prior to randomization
    E.4Principal exclusion criteria
    1. Subjects with symptoms of chronic prostatitis for less than 3 months of the last 6 months prior to Screening.
    2. Subjects with a post-void residual (PVR) volume >200 mL at Screening.
    3. Subjects with a mean total volume voided of >3000 mL per 24 hours, as confirmed by the diary completed prior to Randomization.
    4. Subjects with greater than 1+ hematuria on dipstick test at Screening, unless fully investigated to rule out significant urological disease.
    5. Subjects with a microbiologically-proven UTI, at Screening or Randomization.
    6. Patients with urologic conditions that may result in symptoms that may be confused with chronic prostatitis eg Recurrent urinary tract infection.
    7. Subjects with a history, evidence or suspicion of prostate cancer, unless previously excluded by biopsy. Those aged over 40 years with a Screening PSA ≥10, unless prostate cancer has previously been excluded by biopsy.
    8. Patients using urinary catheters or who have undergone recent urologic procedures.
    9. Patients commencing new bladder training or electrostimulation therapy regime. Established regimes may be continued provided they are not altered during the course of the study.
    10. Taking other treatments for chronic prostatitis at Screening.
    11. Use of any investigational medication within 30 days (or 5 x half life, whichever is longer) prior to the initial pain assessment period in the 7 days prior to randomization or plans to receive an investigational medication other than the study medication during the course of this study.
    12. History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein or hypersensitivity to any ingredients of the formulation.
    13. History of intolerance or hypersensitivity to paracetamol or any of its excipients or existence of a medical condition or use of concomitant medication for which the use of paracetamol is contraindicated (refer to product labeling).
    14. Resting, sitting blood pressure (BP) ≥160 mm Hg in systolic pressure or ≥100 mm Hg in diastolic pressure at Screening. If a patient is found to have untreated significant hypertension at Screening and antihypertensive treatment is initiated, assessment for study eligibility should be deferred until BP and antihypertensive medication have been stable for at least one month. For patients with previously diagnosed hypertension, antihypertensive medications must be stable for at least 1 month prior to Screening.
    15. Signs and symptoms of clinically significant cardiac disease in the 6 months prior to Screening. Patients with a history of heart block now controlled by a functioning cardiac pacemaker are eligible.
    16. Subjects with a relevant neurological disease at Screening with which their CP symptoms may be associated (eg, Parkinson’s disease, spinal cord injury, spinal cord lesion, familial neuropathy, spina bifida or diabetic cystopathy); history, diagnosis, or signs and symptoms of clinically significant neurological disease.
    17. Diagnosis of a transient ischemic attack in the 6 months prior to Screening, diagnosis of stroke with residual deficits (eg, aphasia, substantial motor or sensory deficits) that would preclude completion of required study activities.
    18. History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder.
    19. Presence of drugs of abuse on urine drug screen, unless arising from medication that is medically indicated or prescribed by a physician.
    20. Subjects with a history of alcohol, analgesic or drug abuse in the past 2 years.
    21. History of cancer within 2 years prior to Screening, except for cutaneous basal cell or squamous cell cancer cured by excision.
    22. Subjects with active Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV) infection or who are known carriers at Screening.
    23. Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.0 times the upper limit of normal, or creatinine exceeding 1.7 mg/dL (150μmol/L). Repeat confirmatory tests may be performed.
    24. Planned surgical procedure during the duration of the study.
    25. Intention to donate blood/blood products during the study or up to 3 months after completion of the study.
    26. Any significant, uncontrolled acute or chronic disease, including psychiatric disorders, cognitive impairment or laboratory abnormality, or any other condition, which would increase the risk associated with study participation or investigational product administration or interfere with the interpretation of study results or, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change from Baseline to Week 6 in average daily pain as measured by an 11-point NRS derived from the daily diary.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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 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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 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
    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 months11
    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 months11
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 34
    F.4.2.2In the whole clinical trial 74
    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 Decision2009-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-03-17
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