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    Summary
    EudraCT Number:2007-002381-36
    Sponsor's Protocol Code Number:A6061046
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-09-20
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2007-002381-36
    A.3Full title of the trial
    A MULTI-CENTER, LONG TERM, OPEN-LABEL STUDY OF [S,S]-REBOXETINE (PNU-165442G) ADMINISTERED ONCE DAILY IN PATIENTS WITH FIBROMYALGIA
    A.4.1Sponsor's protocol code numberA6061046
    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 Inc.
    B.1.3.4CountryUnited States
    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 name[S,S]-Reboxetine Succinate
    D.3.2Product code PNU-165442G
    D.3.4Pharmaceutical form 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.3.9.3Other 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.3.11 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.IMP: 2
    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 name[S,S]-Reboxetine Succinate
    D.3.2Product code PNU-165442G
    D.3.4Pharmaceutical form 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.3.9.3Other 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 No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    pain and associated symptoms in patients with 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 assess the long-term safety and tolerability of [S,S]-reboxetine (QD) in patients with fibromyalgia
    E.2.2Secondary objectives of the trial
    • To assess the long-term efficacy of [S,S]-reboxetine (QD) in the management of fibromyalgia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female of any race, at least 18 years of age;
    2. Female patients must be non-pregnant and non-lactating, and be either postmenopausal, surgically sterilized, or using an appropriate method of contraception. Prior to starting the trial, 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, Depo-Provera, or condoms. Women of childbearing potential must have a confirmed negative serum pregnancy test at the Screening visit (Visit 1);
    3. Patients must have personally signed and dated a legally effective written informed consent prior to admission to the study;
    4. At screening (V1), patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites);
    5. At screening (V1), patients must have a score of ≥40 mm on the Pain Visual Analog Scale (VAS);
    6. Patients must be willing and able to understand and cooperate with study procedures.
    E.4Principal exclusion criteria
    1. Patients with other severe pain (e.g., DPN and PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia;
    2. Patients with any inflammatory musculoskeletal disorders, rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders;
    3. Previous participation in a clinical trial with [S,S]-reboxetine or currently receiving treatment with Edronax® for any condition;
    4. Any patients judged clinically to be at risk of suicide based on Beck’s Scale for Suicide Ideation (BSS) and clinical judgement;
    5. Patients 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;
    6. History of uncontrolled narrow angle glaucoma;
    7. History of recurrent syncope or evidence of low blood pressure (<90 mm Hg systolic or <40 mm Hg diastolic);
    8. Evidence of postural hypotension e.g. falls in systolic blood pressure of >20 mmHg or diastolic blood pressure >10 mmHg on standing (from supine);
    9. Patients 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);
    10. History of chronic hepatitis B or C, acute hepatitis A, B or C within the past 3 months, or HIV infection;
    11. Patients with serious hepatic, respiratory, haematologic, renal or immunologic illnesses, or unstable cardiovascular disease;
    12. Malignancy within the past 2 years with the exception of basal cell carcinoma;
    13. Patients with a history of illicit drug or alcohol abuse within the last 2 years;
    14. Patients with significant hepatic impairment (i.e. AST, ALT or total bilirubin > 1.5 x ULN);
    15. Platelet count <100 x 109/L; white blood cell (WBC) count <2.5 x 109/L; neutrophil count <1.5 x 109/L;
    16.Westergren erythrocyte sedimentation rate (ESR) >40 mm/hr;
    17. Abnormal antinuclear antibody (ANA 1:160 titre), or rheumatoid factor (RF >80 IU/mL);
    18. Abnormal (clinically relevant) 12 lead electrocardiogram (ECG). See ‎Appendix 8 of the protocol;
    19. Patients taking any other experimental drugs within 30 days prior to screening (V1), or according to local regulation if greater than 30 days;
    20. Patients with active GI disease including any GI surgery that in the opinion of the investigator would interfere with the absorption of study medication;
    21. Patients with difficulties swallowing tablets or unable to tolerate oral medication;
    22. Use of prohibited pain/sleep medications (including antidepressants, sedatives, hypnotics, opiates, muscle relaxants) in the absence of appropriate washout periods);
    23. Clinically significant or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise participation in the trial;
    24. Patients 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-patients involved in legal cases related to fibromyalgia).
    25. 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;
    26. History of mania, hypomania, other psychotic disorder, or current mood disorder with psychotic features, as diagnosed by the M.I.N.I.;
    27. History of urinary retention;
    E.5 End points
    E.5.1Primary end point(s)
    The following parameters will be obtained in order to determine the safety and tolerability of [S,S]-reboxetine in patients with fibromyalgia.
    1. Vital signs (supine/standing blood pressure and pulse)
    2. Physical examination
    3. 12-lead ECG
    4. Hematology/Biochemistry
    5. Adverse events
    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 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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 175
    F.4.2.2In the whole clinical trial 500
    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 Decision2007-12-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-31
    P. End of Trial
    P.End of Trial StatusCompleted
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