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    Summary
    EudraCT Number:2007-007083-22
    Sponsor's Protocol Code Number:Protocol 37822681SCH2002
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-11-28
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2007-007083-22
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group
    Study to Evaluate the Efficacy and Safety of 3 Fixed Doses of JNJ-37822681
    Administered Twice Daily in Subjects With Schizophrenia
    A.4.1Sponsor's protocol code numberProtocol 37822681SCH2002
    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 SponsorJanssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
    B.1.3.4CountryBelgium
    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 nameJNJ37822681
    D.3.2Product code R600472 eq. 10 mg (F002) and 20 mg (F003)
    D.3.4Pharmaceutical form Capsule*
    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 INNNot available
    D.3.9.1CAS number Not availabl
    D.3.9.2Current sponsor codeJNJ-37822681
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number10 b.i.d. to 30 b.i.d.
    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 RoleComparator
    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 Yes
    D.2.1.1.1Trade name Zyprexa (olanzapine)
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lily and Company
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameZyprexa (olanzapine)
    D.3.4Pharmaceutical form Capsule*
    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 INNolanzapine
    D.3.9.1CAS number 132539-06-1
    D.3.9.2Current sponsor codeF318 and F292
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 10
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    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
    Schizophrenia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level HLGT
    E.1.2Classification code 10039628
    E.1.2Term Schizophrenia and other psychotic disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective
    The primary objective is to evaluate the efficacy via the changes from baseline in the total Positive and Negative Syndrome Scale (PANSS) score of three fixed doses of JNJ-37822681 compared with placebo after 6 weeks’ treatment in subjects with schizophrenia.
    E.2.2Secondary objectives of the trial
    · To evaluate the safety of three fixed doses of JNJ-37822681,
    · To assess the effect on the changes from baseline in the PANSS subscales and the CGI S of illness
    · To assess the effect on the changes from baseline in BMI, body weight, plasma metabolic endpoints (fasting total cholesterol, triglycerides, high-density lipoproteins (HDL), low-density lipoproteins (LDL), very-low-density lipoproteins (VLDL), free fatty acids, HbA1c, glucose, and insulin) and SWN
    · To assess the acute response relative to placebo and olanzapine using the changes from baseline in the NOSIE in the first 2 weeks
    · To explore the pharmacokinetics and the relationship between pharmacokinetics and efficacy parameters (e.g., change in PANSS scores) and safety parameters (e.g., treatment emergent EPS, or other adverse events),
    · To explore genes/genotypes that may be related to clinical response, non-response, to safety parameters, or to pharmacokinetics of JNJ 37822681.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male and female between 18 and 65 years of age, inclusive
    • BMI maximum 40 kg/m2, inclusive (BMI = weight/height2)
    • Subjects must have been diagnosed with schizophrenia according to
    DSM-IV (295.10, 295.20, 295.30, 295.60, 295.90) at least 1 year prior to
    screening.
    • Subjects must have signed an informed consent document indicating that
    they understand the purpose of and procedures required for the study and
    are willing to participate in the study. It is acceptable to have additional
    signatures if required by local regulations. Subjects who are unable to
    provide their own consent or who have been involuntarily committed to
    psychiatric hospitalization are not eligible to enroll in the study.
    • Subjects must be experiencing an acute exacerbation of less than
    6 months duration, with a PANSS total score at screening between
    70 and 120 inclusive and at baseline of between 60 and 120 inclusive.
    • Women must meet one of the following:
    – postmenopausal (amenorrhoea for at least 12 months and follicle
    stimulating hormone (FSH) concentrations of >40 MIU/mL at
    screening),
    – surgically sterile (have had a hysterectomy or bilateral oophorectomy,
    tubal ligation, or otherwise be incapable of pregnancy),
    – abstinent (at the discretion of the investigator/per local regulations),
    – or if sexually active, be practicing an effective method of birth control
    (e.g., prescription oral contraceptives, contraceptive injections,
    contraceptive patch, intrauterine device, double-barrier method [e.g.,
    condoms, diaphragm, or cervical cap with spermicidal foam, cream,
    or gel], male partner sterilization) as local regulations permit,
    before entry, and must agree to continue to use the same method of
    contraception throughout the study.
    • Women of childbearing potential must have a negative urine β-human
    chorionic gonadotropin (β-hCG) pregnancy test at screening and at
    baseline before receiving the study drug..
    • Subjects must agree to voluntary hospitalization for a minimum of
    14 days.
    • Subjects must be willing and able to fill out self-administered
    questionnaires.
    • Subjects must be able to be compliant with self-administration of
    medication, or have consistent help/support available.
    • Subjects themselves, or caregivers or relatives with whom they are
    living, have to be reachable by phone on a regular basis.
    • Subjects must be willing and able to adhere to the prohibitions and
    restrictions specified in this protocol.
    • To participate in the optional pharmacogenomic component of this study,
    subjects (or their legally acceptable representative) must have signed the
    informed consent form for pharmacogenomic research indicating
    willingness to participate in the pharmacogenomic component of the
    study (where local regulations permit). Refusal to consent for this
    component does not exclude a subject from participation in the clinical
    study. All subjects should indicate whether or not they want to
    participate.
    E.4Principal exclusion criteria
    • A DSM-IV axis I diagnosis other than schizophrenia that has been the
    focus of treatment or cause of disability in the last 6 months. For
    example, a major depressive episode that required treatment.
    • A DSM-IV diagnosis of substance dependence within 6 months prior to
    screening evaluation (nicotine and caffeine dependence are not
    exclusionary); patients with a positive urine drug screen at screening may
    be included provided use does not lead to a DSM-IV diagnosis of
    substance dependence, and investigators should instruct them to abstain
    from alcohol and illegal drugs within 3 days prior to Day –1 and at any
    time during the study).
    • Any clinically relevant medical condition that could potentially alter the
    absorption, metabolism, or excretion of the study medication, such as
    Crohn’s disease, liver disease, or renal disease.
    • Relevant history of any significant and/or unstable cardiovascular,
    respiratory, neurological (including seizures) or significant
    cerebrovascular, renal, hepatic, endocrine, or immunologic diseases.
    • History of neuroleptic malignant syndrome.
    • A history of diabetes or currently receiving a glucose lowering agent or
    treatment for diabetes.
    • Subjects suffering from glaucoma.
    • Other significant and/or unstable systemic illnesses.
    • Allergy or hypersensitivity to any known antipsychotic compounds.
    • Inability to swallow the study medication whole with the aid of water
    (subjects may not chew, divide, dissolve, or crush the study medication,
    as this may affect the release profile).
    •Patients who have never been treated with antipsychotics
    • Previous history of lack of response to antipsychotic therapy, including
    olanzapine, when acutely psychotic (lack of response is defined as the
    subject having had [at least twice] a documented medical history of no
    clinical response, despite adequate doses and durations of treatment, or
    the inability to tolerate doses in the indicated dosage range).
    • Previous use of clozapine for the indications of treatment resistance or
    reduction of suicidal risk.
    • Exposure to an experimental drug or experimental medical device within
    90 days before screening.
    • Significant risk of suicidal or violent behavior.
    • Female subjects who are pregnant or breastfeeding.
    • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
    concentrations more than 2 times the upper limit of normal at screening.
    • Other biochemistry, hematology, or urinalysis results that are not within
    the laboratory’s reference range, and that are deemed by the investigator
    to be clinically significant.
    • Clinically significant abnormal observations in Vital Signs. If vital sign
    values significantly lie outside the normal ranges at screening, agreement
    with the J&J PRD Safety Physician must be obtained prior to inclusion
    of the subject.
    • Clinically significant abnormal observations in ECG defined as:
    – A confirmed screening visit QTcB interval ≥470 msec.
    – A history of additional risk factors for torsades des pointes (e.g. heart
    failure, hypokalemia, family history of Long QT Syndrome).
    – The use of concomitant medications that prolong the QT/QTc interval.
    • Use of weight loss drugs such as orlistat, sibutramine or rimonabant.
    • Use of Chantix® (varenicline)
    • Injection of a depot antipsychotic within 120 days before screening, or
    use of paliperidone palmitate within 10 months before screening.
    • Use of monoamine oxidase inhibitors within 4 weeks or fluoxetine
    within 5 weeks before screening. Use of all other antidepressants within
    2 weeks before screening.
    • Use of mood stabilizers (e.g., anticonvulsants and/or lithium) within
    2 weeks before baseline.
    • Received electroconvulsive therapy within 3 months before screening.
    • Have been involuntarily committed to psychiatric hospitalization.
    • Any condition that, in the opinion of the investigator, would compromise
    the well-being of the subject or the study or prevent the subject from
    meeting or performing study requirements.
    • Employees of the investigator or study center, persons with direct
    involvement in the proposed study or other studies under the direction of
    that investigator or study center, or family members of the employees or
    the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy will be based on the change from baseline of the total PANSS score of three fixed doses of JNJ 37822681 compared with placebo after 6 weeks’ treatment.

    Other efficacy criteria include the PANSS subscales, the CGI-S of illness, the SWN compared with placebo at 6 weeks, and compared to olanzapine at 12 weeks. Assessment of the acute response to JNJ 37822681 relative to placebo will be assessed using the changes from baseline in the NOSIE in the first 2 weeks while subjects are hospitalized.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Olanzapine
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    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 months5
    E.8.9.1In the Member State concerned days9
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 475
    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 Decision2008-11-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-02-01
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