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    Summary
    EudraCT Number:2006-002404-34
    Sponsor's Protocol Code Number:F02695 LP 202
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-09-11
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2006-002404-34
    A.3Full title of the trial
    A DOUBLE BLIND, MULTINATIONAL, MULTICENTRE, PLACEBO-CONTROLLED 10-WEEK STUDY ASSESSING THE EFFICACY AND SAFETY OF F2695 SR FLEXIBLE DOSE (75,100 MG /DAY) IN THE TREATMENT OF PATIENTS WITH MAJOR DEPRESSIVE DISORDER
    EFFICACY AND TOLERANCE OF F2695 SR IN MAJOR DEPRESSIVE DISORDER
    A.4.1Sponsor's protocol code numberF02695 LP 202
    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 SponsorPierre Fabre Médicament
    B.1.3.4CountryFrance
    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 nameF2695
    D.3.2Product code F2695SR
    D.3.4Pharmaceutical form Prolonged-release capsule, hard
    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.3.9.2Current sponsor codeF2695
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeF2695
    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 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 placeboProlonged-release capsule, hard
    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
    Major Depressive Disorder
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study the clinical efficacy of F2695 SR flexible dose (75, 100 mg /day) compared to placebo in patients with MDD through the assessment of MADRS after 10 weeks of treatment.
    E.2.2Secondary objectives of the trial
    -To assess the efficacy of F2695 SR flexible dose (75, 100 mg /day) versus placebo through the assessment of CGI improvement, Sheehan Disability Scale, HAM-D17 and COVI scale after 10 weeks of treatment,
    - To assess the efficacy of F2695 SR flexible dose (75, 100 mg/day) versus placebo on somatic complaints through the assessment of Visual Analog Scales after 10 weeks of treatment.
    -To assess the safety of F2695 SR flexible dose (75, 100 mg /day) versus placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    male or female aged 18-70 years, Female of child bearing potential using a medically accepted method of contraception for at least 2 months before inclusion in the study or documented sterility or post-menopause (1 year amenorrhoea), out patient, meeting DSM-IV criteria for Major Depressive Episode diagnosed using a structured interview (MINI), moderate or severe, unipolar, without psychotic features, Duration of current episode: at least 1 month, with a HAM-D17 total score > 22 at selection and inclusion visits, with a Sheehan Disability Scale total score > or = 10 and with at least one score > or = 6 on one of the subscales at selection and inclusion visits, ithout any clinically relevant abnormalities in clinical examination, laboratory tests and ECG parameters
    E.4Principal exclusion criteria
    Patient at significant risk of suicide as assessed with the MINI§ Resistance to two well-conducted antidepressant treatments (defined by a lack of response to at least 2 treatments prescribed at their effective dose and during at least 4 weeks ) for the current episode, Any history of bipolar disorder, psychotic episode or disorder, Any current Panic disorder, Agoraphobia, Obsessive compulsive disorder, Generalized anxiety or Post Traumatic Stress Disorder, when the onset preceded the onset of the depressive episoden, Current major personality disorder of clinical significance, History of alcohol or drug abuse according to DSM IV criteria within the 6 months preceding selection, Fibromyalgia Syndrome, Chronic Fatigue Syndrome, Severe underlying or ongoing systemic disease, Previous history of generalized or partial seizure, Cardiovascular disease including myocardial infarction, cardiac failure, uncontrolled arterial hypertension, Known cardiac rhythm or conduction disorder, Known prostatic disorder and/or dysuria, Known acute glaucoma, Hepatic insufficiency, Stroke or any organic cerebral disease, Pregnancy or breast-feeding, ECG: QT or QTc greater than the upper limit of the normal range, Non-response to milnacipran for a previous episode
    E.5 End points
    E.5.1Primary end point(s)
    Change in MADRS total score from baseline to Day 70.
    Main efficacy analysis: MMRM (likelihood-based Mixed-effects Model Repeated Measures) analysis on MADRS total score changes from baseline over time with Treatment, Centre, Visit as categorical fixed factors, MADRS total score baseline as covariate, and, treatment-by-visit and baseline-by-visit interactions on the Full Analysis Set. Appropriate contrasts on treatment factor and treatment-by-visit interaction to estimate the difference between treatment group in mean change from baseline to D70.
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    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.8.5The trial involves multiple Member States Yes
    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
    The end of study is the date of 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 months0
    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 months0
    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) No
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 391
    F.4.2.2In the whole clinical trial 534
    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 Decision2006-10-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-10-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-10-22
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