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    Summary
    EudraCT Number:2004-002156-34
    Sponsor's Protocol Code Number:28133
    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:2006-01-09
    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 number2004-002156-34
    A.3Full title of the trial
    Double-blind, placebo-controlled trial investigating the safety of re-exposure to 900 mg of Org 34517, used as adjunctive therapy in subjects with psychotic major depression (major depressive episode, severe, with psychotic features), who participated in Trial 28130
    A.4.1Sponsor's protocol code number28133
    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 SponsorNV Organon
    B.1.3.4CountryNetherlands
    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 nameOrg 34517
    D.3.2Product code Org 34517
    D.3.4Pharmaceutical form 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.3.9.1CAS number 189035-07-2
    D.3.9.2Current sponsor codeOrg 34517
    D.3.9.3Other descriptive name(11ß,17ß)-11-(1,3-benzodioxol-5-yl)-17 -hydroxy-17-(1-propynyl)estra-4,9-dien-3 -one))
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Yes
    D.3.11.13.1Other medicinal product typea medicinal product with an active substance of chemical origin
    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 placeboCapsule, 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
    Psychotic major depression (major depressive episode, severe, with psychotic features)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 6.1
    E.1.2Level LLT
    E.1.2Classification code 10037250
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To measure safety and tolerability of re-exposure to 2 weeks of adjunctive therapy with Org 34517 during treatment and up to 2 weeks after discontinuation in subjects with psychotic depression on ‘usual treatment’, who were recently treated with 900 mg Org 34517 in trial 28130 (prospective, double-blind, randomized, placebo-controlled dose finding study of the efficacy and safety of 2 target doses of Org 34517 used as adjunctive therapy in subjects with psychotic depression).
    E.2.2Secondary objectives of the trial
    To measure safety and tolerability of re-exposure to 2 weeks of adjunctive therapy with Org 34517 during treatment and up to 2 weeks after discontinuation in subjects with psychotic depression on ‘usual treatment’, who were recently treated with 300 mg Org 34517 in trial 28130.
    To study efficacy of re-exposure to 2 weeks of adjunctive therapy with Org 34517 in subjects with psychotic depression on ‘usual treatment’, who were recently treated with 900 mg Org 34517 in trial 28130.
    To study efficacy of re-exposure to 2 weeks of adjunctive therapy with Org 34517 in subjects with psychotic depression on ‘usual treatment’, who were recently treated with 300 mg Org 34517 in trial 28130.
    To study the maintenance of treatment effect of a re-exposure of 2 weeks of adjunctive therapy with Org 34517 in subjects with psychotic depression on ‘usual treatment’ up to 2 weeks after the discontinuation of adjunctive treatment, who were recently treated with 300 or 900 mg Org 34517 in trial 28130.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    a) provide voluntary written informed consent for trial participation after the scope and nature of the investigation have been explained to them, and before starting any trial-related activities;
    b) have attended Screening, Baseline, Visit Day 15, Day 29 and Day 43 of trial 28130;
    c) have a CGI of Severity score of 3 or greater at Day 43 of trial 28130 and at Day 1 of trial 28133, or a lower score when the investigator is of the opinion that further resolution of symptoms is warranted; and
    d) be on a stable dose of ‘usual treatment’, which must consist of an antidepressant, an antipsychotic, a mood stabilizer or any combination of these 3 drug classes.
    E.4Principal exclusion criteria
    a) have experienced any of the following significant safety outcomes in trial 28130:
    1. Severe breakthrough bleeding;
    2. Diagnosis of prostatitis;
    3. Abnormal level of testosterone at Day 15 of trial 28130;
    4. A significant increase in suicidality at any time point as evidenced by an ISST score > 9 or an increase of 3 points or more post-randomisation;
    5. A doubling of trial 28130 screening values in two or more tests of hepatic function (ASAT, ALAT, bilirubin, alkaline phosphatase or gamma GT);
    6. Emergent dermatological condition or worsening of a pre-existing dermatological condition;
    7. A clinically significant abnormal ECG, as judged by the QECG cardiologist;
    8. For male subjects: Obstructive urinary symptoms;
    9. Any adverse event deemed relevant for exclusion in trial 28133 by the investigator.
    b) have an abnormal PSA test at Day -7 of trial 28133
    c) are at significant risk of committing suicide, as indicated by a score greater than 9 on the revised ISST at Day -7 or Day 1;
    d) are currently treated with carbamazepine or valproate;
    e) are currently treated with midazolam;
    f) are currently treated with clozapine;
    g) have been treated with electroconvulsive therapy (ECT) in the current episode;
    h) are currently treated with more than one antidepressant;
    i) are currently treated with more than one antipsychotic;
    j) are currently treated with more than one mood stabilizer;
    k) have ‘usual treatment’ started or discontinued in the 2 weeks before Day 1;
    l) have a ‘usual treatment’ dose change within one week prior to Day 1;
    m) have any clinically unstable or uncontrollable renal, hepatic, respiratory, hematological, cardiovascular or cerebrovascular disease that would put the patient at risk of safety or bias assessment of efficacy;
    n) have known hypersensitivity reactions to glucocorticoid antagonists;
    o) have any clinically significant abnormal laboratory data (e.g. aspartate amino transferase (ASAT) and/or alanine amino transferase (ALAT) values > 2x normal range upper limit) or ECG results, or a clinically significant abnormal outcome at the physical examination at Day -7;
    p) have a confirmed positive result on the drug screening test for any illicit drug, except cannabis, at Day -7;
    q) have any untreated or uncompensated clinically significant endocrine disorder;
    r) are using hormone replacement therapy at Day -7;
    s) require concomitant treatment with corticosteroids, like dexamethasone, prednisone or cortisol (topical use is allowed);
    t) are women of childbearing potential without adequate contraception (an IUD, oral contraceptives in combination with a barrier method or a condom combined with spermicide, are considered adequate); or
    u) are women with a positive pregnancy test at Day -7 or 1, or are breast feeding mothers;
    v) are currently treated with systemic or topical ketaconazole.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability of re-exposure to 2 weeks of adjunctive therapy with Org 34517
    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 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) 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 No
    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 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
    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 months5
    E.8.9.1In the Member State concerned days
    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 No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-01-09. Yes
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 60
    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 Decision2005-06-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-06-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-06-09
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