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    Summary
    EudraCT Number:2004-004232-31
    Sponsor's Protocol Code Number:A6061025
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-02-22
    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 ConcernedUK - MHRA
    A.2EudraCT number2004-004232-31
    A.3Full title of the trial
    A double-blind (third party open), placebo-controlled, parallel group, multiple dose study to investigate the safety, toleration and pharmacokinetics of [S,S]-Reboxetine in young and elderly healthy volunteers.
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberA6061025
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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
    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 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 nameN/A
    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
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeN/A
    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 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 placeboTablet
    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
    Postherpetic Neuralgia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Level LLT
    E.1.2Classification code 10036376
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the safety and toleration of multiple oral doses of (+)-[S,S]-RBX administeredonce daily in an extended release formulation in young and elderly volunteers.

    To investigate the steady state pharmacokinetics of multiple oral doses of (+)-[S,S]-RBXadministered once daily in an extended release formulation in young and elderly volunteers.
    E.2.2Secondary objectives of the trial
    None
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into thetrial:
    1. Cohorts 1 and 2: Healthy male and/or female subjects between the ages of 18 and 45 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
    2. Cohort 3: Healthy male and/or female subjects aged 65 years (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
    a) Female subjects must fulfill one of the following:
    b) Postmenopausal (two years since last period) subjects must have a negative serum pregnancy test at screening and a negative serum or urine pregnancy test immediately prior to commencing the study period.
    c) Surgically sterilized (tubal ligation). Subjects must have a negative serum pregnancy test at screening and a negative serum or urine pregnancy test immediately prior to commencing the study period.
    d) Surgically sterilized (hysterectomy).
    e) Females of child-bearing potential must be non-lactating and must have successfully practiced, over the last 3 months, one of the following contraceptive methods – oral, depot injection, intrauterine device or diaphragm plus spermicide, condoms, partner has had a vasectomy or abstention and must have a negative serum pregnancy test at screening and a negative serum or urine pregnancy test immediately prior to commencing the study period.
    g) All women of child-bearing potential have to use adequate contraceptive protection throughout the study period and for at least 1 full menstrual cycle after the follow-up visit. Women who have been surgically sterilized do not need to use birth control.
    3. Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs).
    4. 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.
    5. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the trial:
    1. Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
    2. Subjects with any condition possibly affecting drug absorption (eg, gastrectomy).
    3. Subjects with a positive urine drug screen.
    4. History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
    5. Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
    6. Treatment with an investigational drug within the past four months preceding the first dose of trial medication.
    7. 12-lead ECG demonstrating QTc >430 msec (males) and QTc >450 msec (females) at screening.
    8. Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception as outlined in Section 4.4.4 of the protocol from at least 14 days prior to the first dose of trial medication until completion of follow-up procedures.
    9. Subjects who are taking, or have taken, any prescribed or over the counter drug (with the exception of paracetamol, up to 3g per day) in the three weeks prior to the first dose of study medication. Postmenopausal hormone replacement therapy (if stabilized on dose for at least 3 months) and hormonal contraception (if stabilized on a product and dose for at least 3 months) will be allowed. Subjects who are stabilized on certain chronically administered medications may be allowed provided the medications are not predicted to interact with (+)-[S,S]-RBX.
    10. Administration of drugs and/or herbal preparations capable of inducing hepatic metabolism (eg barbiturates, rifampicin, carbamazepine, phenytoin, primidone or St John’s Wort) or monamine oxidase inhibitors (MAOIs) within 30 days (or 5 half-lives of the substance, whichever is longer) of enrollment in this study.
    11. Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
    12. History of sensitivity to heparin or heparin-induced thrombocytopenia.
    13. Subjects with a resting supine blood pressure below 100/55mmHg or who show a postural drop in either systolic or diastolic blood pressure of ³20mmHg at screening.
    14. Subjects unwilling or unable to comply with the Lifestyle guidelines presented in Section 4.4. of the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoints: Safety and toleration of (+)-[S,S]-RBX; adverse event reporting, laboratorysafety tests, 12-lead ECG’s, vital signs and physical examination.

    Pharmacokinetic Endpoints: Pharmacokinetic profiles; plasma concentrations of (+)-[S,S]-RBXwill be measured on Day 10 (young) and 15 (elderly) to determine the multiple dose pharmacokinetics of (+)-[S,S]-RBX. Pharmacokinetic parameters: Cmax, tmax, Cmin, AUC0-t Cav, peak to trough ratio and peak to trough fluctuation.
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    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) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Third Party Open
    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
    As specified in teh protocol.
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months5
    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 Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    As specified in the protocol.
    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 Decision2004-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-11-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2005-03-29
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