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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2008-006760-10
    Sponsor's Protocol Code Number:A6061054
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-12-09
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2008-006760-10
    A.3Full title of the trial
    A 6-MONTH, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER,
    PARALLEL GROUP, MAINTENANCE OF EFFECT STUDY OF ESREBOXETINE
    (PNU-165442G) ADMINISTERED ONCE DAILY (QD) IN PATIENTS WITH
    FIBROMYALGIA
    A.4.1Sponsor's protocol code numberA6061054
    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 nameesreboxetine 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 INNesreboxetine
    D.3.9.1CAS number 98769-81-4
    D.3.9.2Current sponsor codePN-165442 / PNU-165442G
    D.3.9.3Other descriptive name(2S)-2-[(S)-(2-ethoxyphenoxy)phenylmethyl] morpholine succinate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNesreboxetine
    D.3.9.1CAS number 98769-81-4
    D.3.9.2Current sponsor codePN-165442 / PNU-165442G
    D.3.9.3Other descriptive name(2S)-2-[(S)-(2-ethoxyphenoxy)phenylmethyl] morpholine succinate
    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 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 Information not present in EudraCT
    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
    Esreboxetine is being developed for the treatment of fibromyalgia.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10048439
    E.1.2Term Fibromyalgia
    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 of ESRBX (QD) compared with placebo treatment in assessing the maintenance of effect for the treatment of pain intensity and function associated with fibromyalgia.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of ESRBX (QD) compared with placebo treatment on pain
    intensity and global assessment of overall fibromyalgia status, functional status, global assessment scores, sleep and fatigue associated with fibromyalgia;

    To evaluate the long-term safety and tolerability of ESRBX compared with placebo for
    the treatment of fibromyalgia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet the following criteria to be eligible to participate in the study. These criteria are mandatory and must be met to provide evaluable data.
    1. Male or female of any race, at least 18 years of age;
    2. Female subjects must be non-pregnant and non-lactating, and be either postmenopausal (at least 1 year following the last menstrual period), surgically sterilized, or using an appropriate method of contraception. Prior to starting the study, it is strongly recommended that women of childbearing potential use two of the following methods of birth control for at least one month or for whatever amount of time the prescribing doctor determines it will take for the methods of birth control to be fully effective: oral birth control pills, diaphragms, progesterone implanted rods, medroxyprogesterone acetate, or condoms. Women of childbearing potential must have a confirmed negative serum pregnancy test at the Screening visit (V1);
    3. Subjects must have personally signed and dated a legally effective written informed consent prior to admission to the study;
    4. At screening (V1), subjects must meet the American College of Rheumatology (ACR) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in atleast 11 of 18 specific tender point sites);
    5. At screening (V1), subjects must have a score greater than or equal to 40 mm on the pain Visual Analogue Scale;
    6. At randomization (V2/R), at least 4 daily pain diaries must be completed satisfactorily within the last 7 days and the mean daily pain score must be greater than or equal to 4.0 points;
    7. At randomization (V2/R), subjects must have a FIQ-Total score greater than or equal to 45 points;
    8. Subjects must be willing and able to understand and cooperate with study procedures.
    E.4Principal exclusion criteria
    Subjects may not participate in the study if they meet any of the following criteria:
    1. Subjects with other severe pain (eg, DPN and PHN) that may confound assessment or self evaluation of the pain associated with fibromyalgia;
    2. Subjects with any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), clinically significant active infection, or untreated endocrine disorder;
    3. Previous exposure or participation in a clinical study with ESRBX or currently receiving treatment with Edronax® for any condition;
    4. Subjects who have a history of a seizure disorder including alcoholic seizures, a family history of seizures or a history of head trauma that resulted in loss of consciousness or concussion;
    5. History of uncontrolled narrow angle glaucoma;
    6. History of urinary retention;
    7. Abnormal (clinically relevant) 12-lead electrocardiogram (see section Appendix 14);
    8. History of recurrent syncope or evidence of low blood pressure (<90 mmHg systolic or <40 mmHg diastolic);
    9. Evidence of postural hypotension eg, falls in systolic blood pressure of >20 mmHg or diastolic blood pressure >10 mmHg on standing (from supine);
    10. Subjects with uncontrolled hypertension;
    11. Subjects with a history of transient ischemic attacks, stroke, or the presence of a carotid bruit (unless significant carotid stenosis (>70%) has been ruled out by appropriate investigation);
    12. History of chronic hepatitis B or C, acute hepatitis A, B or C within the past 3 months, or HIV infection;
    13. Malignancy within the past 2 years with the exception of basal cell carcinoma;
    14. Subjects with a history of illicit drug or alcohol abuse within the last 2 years;
    15. Subjects with significant hepatic impairment (ie, confirmed AST, ALT or Total Bilirubin >1.5 x ULN);
    16. Platelet count <100 × 109/L; white blood cell count <2.5 x 109/L; neutrophil count <1.5 x 109/L;
    17. Westergren erythrocyte sedimentation rate (ESR) >40 mm/hr;
    18. Abnormal antinuclear antibody (ANA ≥1:160 titre), or rheumatoid factor (RF >80
    IU/mL);
    19. Subjects taking any other experimental drugs within 30 days prior to screening (V1), or according to local regulation if greater than 30 days;
    20. Subjects with active GI disease including any GI surgery that in the opinion of the
    investigator would interfere with the absorption of study medication;
    21. Subjects with difficulties swallowing tablets or unable to tolerate oral medication;
    22. Use of prohibited pain/sleep medications (including antidepressants, sedatives, longacting hypnotics, opiates, muscle relaxants; see Table 2, Section 5.5.1) in the absence of appropriate washout periods;
    23. Subjects with pending Worker’s Compensation, Workman’s Compensation, civil
    litigation or disability claims pertinent to the patient’s fibromyalgia; current involvement in out-of-court settlements for claims pertinent to the patient’s fibromyalgia; or currently receiving monetary compensation as a result of any of the above (USA only; for non-US centers-subjects involved in legal cases related to fibromyalgia);
    24. A current or recent diagnosis (last 6 months) or episode of major depressive disorder, dysthymia (as diagnosed by M.I.N.I.) and/or uncontrolled depression;
    25. History of mania, hypomania, other psychotic disorder, or current mood disorder with psychotic features, as diagnosed by M.I.N.I;
    26. Any subjects judged by a mental healthcare professional (a psychiatrist or licensed PhD level clinical psychologist) to be at risk of suicide based on Columbia-Suicide Severity Rating Scale (C-SSRS) and Suicide Behaviors Questionnaire-Revised (SBQ-R) with exclusionary cut-off values for the SBQ-R total score of ≥8 and item-1 score of ≥2;
    27. Subjects with serious hepatic, respiratory, hematologic, renal or immunologic illnesses, or unstable cardiovascular disease;
    28. Clinically significant or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to V10 and V13/T in the mean daily pain rating score measured by the 11-point pain intensity Numerical Rating Scale (NRS) where scores range from 0-10; baseline is defined as the mean daily pain rating score at randomization (V2/R);
    Change from baseline to V10 and V13/T in the FIQ-Total score where scores range from 0-100; baseline is defined as the FIQ-Total score at V2/R.
    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 Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    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 Yes
    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) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA59
    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
    End of trial would be, LSLV
    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 years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days19
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    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 No
    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 320
    F.4.2.2In the whole clinical trial 800
    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 Decision2008-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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