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    Summary
    EudraCT Number:2008-002066-57
    Sponsor's Protocol Code Number:3151A6-2000
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-04-03
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2008-002066-57
    A.3Full title of the trial
    Multicenter, Open-Label, Safety, Tolerability, and Pharmacokinetic Study to Evaluate Single Ascending Doses and Subsequent Short-Term Administration of Fixed Doses of Desvenlafaxine Succinate Sustained-Release Tablets in the Treatment of Child and Adolescent Outpatients With Major Depressive Disorder.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Child And Adolescent Outpatients With Major Depressive Disorder
    A.4.1Sponsor's protocol code number3151A6-2000
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00619619
    A.5.4Other Identifiers
    Name:ProtocolNumber:B2061012
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorWyeth Research
    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 supportWyeth Research
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018007181021
    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 nameDesvenlafaxine Succinate
    D.3.2Product code PF-05212375
    D.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation No
    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 INNDESVENLAFAXINE
    D.3.9.1CAS number 93413-62-8
    D.3.9.2Current sponsor codePF-05212375
    D.3.9.3Other descriptive nameDVS-233;DVS-233 Monohydrate;O-Desmethylvenlafaxine succinate monohydrate;ODV succinate monohydrate
    D.3.9.4EV Substance CodeSUB25380
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 200
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    Major Depressive Disorder
    E.1.1.1Medical condition in easily understood language
    Depression
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    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
    1) To investigate the safety and tolerability of single ascending doses of DVS SR in children and adolescents with Major Depressive Disorder (MDD)

    2) To characterize the PK profile of single ascending doses of DVS SR in children and adolescents with MDD.

    E.2.2Secondary objectives of the trial
    1) To characterize population PK in children and adolescents with MDD.
    2) To evaluate the efficacy of DVS SR in children and adolescents with MDD in an exploratory manner.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female outpatient.
    2. Ages greater than equal to (≥) 7 or less than (<)18 years at baseline (study day -1).
    3. Meets Diagnostic and Statistic Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for MDD as assessed by the KIDDIE Schedule for Affective Disorders and Schizophrenia–Present and Lifetime Version (K-SADS-PL) and clinical interview.
    4. Children’s Depression Rating Scale—Revised (CDRS-R) score >40 at the screening and study day -1 (baseline) visits.
    5. Clinical Global Impressions Scale—Severity (CGI-S) score of ≥4 at the screening and study day -1 (baseline) visits.
    6. Depression of at least moderate severity with symptoms for at least 1 month before screening.
    7. Depression that could, in the investigator's opinion, respond to therapy with antidepressant(s) alone (without concomitant psychotherapy).
    8. Able to participate as an inpatient for the first 3.5 days of the study.
    9. Able to swallow a placebo tablet or placebo tablets of size equal to the largest-sized DVS SR tablet studied in the subject’s respective age stratum.
    10. All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 15 days after the last dose of test article.
    11. For sexually active subjects, the signed and dated informed consent and assent forms should reflect an awareness of the stipulations concerning the use of contraception. For sexually active subjects, condoms should be used in addition to other contraceptive methods for the duration of study participation and for 15 days after the last dose of test article in order to provide protection against sexually transmitted diseases and to provide additional protection against accidental pregnancy. It is important that subjects not become pregnant or impregnate others while they are in the study.
    E.4Principal exclusion criteria
    1. History or current evidence of a medical condition known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs.
    2. History or presence of any other medical condition that might confound the study or put the subject at greater risk during participation.
    3. Major acute illness within 90 days before the screening visit.
    4. History of suicide attempt or gesture in which the intent was suicide or serious self-harm.
    5. Acute suicidality to such a degree that precaution against suicide must be exercised.
    6. Screening or baseline (study day -1) score ≥5 on question 13 (Suicidal Ideation) of the CDRS-R.
    7. Screening or baseline (study day -1) score ≥3 on Item 3 (Suicide) of the HAM-D 17 .
    8. Screening or baseline (study day -1) determination of “yes” on question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) for theSuicidal Ideation section of the Columbia Suicide-Severity Rating Scale (C-SSRS).
    9. Screening or baseline (study day -1) determination of “yes” on question 5 (Active Suicidal Ideation with Specific Plan and Intent) for the Suicidal Ideation section.of the C-SSRS.
    10. Screening or baseline (study day -1) determination of “yes” on the question of Actual Attempt for the Suicidal Behavior section of the C-SSRS
    11. First-degree relative who has completed suicide.
    12. Weight below the 10 th percentile for age based on the National Center for Health Statistics growth charts (2000 Centers for Disease Control and Prevention [CDC] growth charts).
    13. Clinically important abnormalities, as determined by the investigator, on screening physical examination, electrocardiogram (ECG), laboratory tests, or urine drug screen (UDS). The investigator and medical monitor will evaluate a positive UDS as to the potential impact and continued participation of the subject in the study.
    14. History of seizure disorder other than a single childhood febrile seizure.
    15. History or presence of Gilbert’s syndrome or a total bilirubin level of U ≥2.0 mmol/dL at screening.
    16. Known hypersensitivity to venlafaxine.
    17. History or presence of MDD with psychotic features.
    18. Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a diagnosis of bipolar disorder or psychotic disorder.
    19. Current (within 12 months before baseline) generalized anxiety disorder, panic disorder, social anxiety disorder, or attention deficit hyperactivity disorder (ADHD) if considered by the investigator to be primary (causing a higher degree of distress or impairment than MDD).
    20. Presence (within 12 months before baseline) of a clinically important personality disorder (such as antisocial, schizotypal, histrionic, borderline, or narcissistic) as assessed during the psychiatric evaluations.
    21. Presence of a mental disorder due to a general medical condition.
    22. History or presence of anorexia or bulimia.
    23. A first-degree relative with bipolar disorder (based on family history by the subject’s legally authorized representative [parent]).
    24. Sexually active male or female subjects who will not use medically accepted forms of contraception during study participation. Refer to the Screening section in the body of the protocol for a list of medically acceptable methods of contraception.
    25. Pregnancy, breastfeeding, lactation, or plans to become pregnant during the study.
    26. Positive serum beta-human chorionic gonadotropin (-HCG) test result during screening.
    27. Received any investigational drugs or devices within 30 days before administration of the first dose of test article.
    28. Use of prohibited treatments. Refer to the Prohibited Treatment, Table of Prohibited Treatments, and Permitted Treatments sections for treatments and associated time frames.
    E.5 End points
    E.5.1Primary end point(s)
    Baseline to Follow-up (up to Day 77):
    -Number of Subjects With Adverse Events AEs) and Serious Adverse Events (SAEs)

    Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56:
    -Maximum Observed Plasma Concentration (Cmax)
    -Time to Reach Maximum Observed Plasma Concentration (Tmax)
    -Plasma Decay Half-Life (t1/2)
    -Area Under the Curve From Time Zero to Infinity (AUC0-∞)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Follow-up (up to Day 77)
    Pre-dose (0 hour) and Post-dose (0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours) on Days 28 and 56
    E.5.2Secondary end point(s)
    Population Pharmacokinetics Dose Normalized AUC (AUC/D): First Method, Second Method
    Population Pharmacokinetics Dose Normalized AUC (AUC/D): Third Method
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1, Day 28, and Day 56
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    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.8.2.4Number of treatment arms in the trial8
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days26
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 59
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 29
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 30
    F.1.2Adults (18-64 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children and Adolescents aged 7 to 17 years
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 59
    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)
    None
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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