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    Summary
    EudraCT Number:2007-004482-18
    Sponsor's Protocol Code Number:R076477-SCH-4013
    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:2007-12-05
    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 number2007-004482-18
    A.3Full title of the trial
    A blinded-initiation study of medication satisfaction in subjects with schizophrenia treated with paliperidone ER after suboptimal response to oral risperidone.
    A.4.1Sponsor's protocol code numberR076477-SCH-4013
    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 SponsorOrtho-McNeil Janssen Scientific Affairs, LLC
    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 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 Yes
    D.2.1.1.1Trade name INVEGA
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen L.P
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical 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 INNPaliperidone
    D.3.9.1CAS number 144598-75-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 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 Yes
    D.2.1.1.1Trade name INVEGA
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen L.P
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical 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 INNPaliperidone
    D.3.9.1CAS number 144598-75-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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: 3
    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 Risperdal
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen L.P
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical 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 INNRisperidone
    D.3.9.1CAS number 106266-06-2
    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 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 Information not present in EudraCT
    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 LLT
    E.1.2Classification code 10039626
    E.1.2Term Schizophrenia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to assess the observed change in the
    Medication Satisfaction Questionnaire (MSQ) score, from baseline to the
    Week 6 endpoint, when paliperidone ER (6 mg to 12 mg) is administered for
    at least 4 weeks to subjects with schizophrenia who are suboptimally
    responsive to oral risperidone 4 mg or 6 mg.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to explore efficacy and safety outcomes in subjects treated with paliperidone ER for up to 6 weeks
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female at least 18 years of age
    2. Must be able to understand, in the opinion of the investigator, the informed consent form approved by the Independent Ethics Committee/Institutional Review Board (IEC/IRB). All subjects must sign the study informed consent document indicating that they understand the purpose of the study and the procedures required for the study and are willing to participate in the study. If a subject has an appointed legal representative, both the representative and the subject will sign the consent form. Subjects who are unable to provide their own consent are not eligible to enroll in the study. In addition, reasonable efforts should be made to provide information about the study to all subjects’ designated contact person.
    3. Female subjects must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and a negative urine pregnancy test at screening.
    4. Male subjects must be abstinent, surgically sterile, or, if sexually active, be practicing an effective method of birth control (e.g. double barrier method, or, their female partner must be surgically sterile, or using prescription oral contraceptives, contraceptive injections, contraceptive patch or have an intrauterine device) before entry and throughout the study.
    5. Be diagnosed with schizophrenia according to DSM IV (295.30 paranoid type, 295.10 disorganized type, 295.90 undifferentiated type, or residual type 295.60)
    6. Have scores of at least 4 ("Moderate") on at least 3 of the following symptom factors of the PANSS at the screening and baseline visits:
    • G4 Tension
    • G9 Unusual thought content
    • P1 Delusions
    • P3 Hallucinatory behavior
    • P4 Excitement
    • P5 Grandiosity
    • P6 Suspiciousness/persecution
    7. Report dissatisfaction with current medication as measured by a TSQM Item #14 score of 1 to 3 ("Extremely Dissatisfied", "Very Dissatisfied", or "Dissatisfied") at the screening and baseline visits
    8. Have an aspect of disease management, which, in the investigator's opinion, could potentially benefit from a change in antipsychotic medication
    9. Receive oral risperidone 4 mg or 6 mg for at least 4 weeks immediately
    before randomization.
    10. Willing and able, in the investigator's opinion, to remain compliant and adhere to the prohibitions and restrictions specified in this protocol
    11. Be able, in the opinion of the investigator, to comply with self-administration of medication or have consistent help/support available to supervise medication administration
    12. Outpatients, who in the opinion of the investigator, are likely to remain
    outpatient during the course of the study (subjects who are chronically
    hospitalized for purely social reasons, but otherwise meet entry criteria, may be considered for inclusion on a case-by-case bases after review by
    the sponsor).
    E.4Principal exclusion criteria
    General:

    1. Inability to swallow study drug whole with the aid of water (subjects may not chew, divide, dissolve, or crush the study drug, as this may affect the release profile)
    2. Have received an investigational drug, used an investigational medical device, or participated in a clinical study that altered their medication within 6 months before the first administration of study drug, or have participated in more than 2 investigational drug studies within the past 12 months
    3. Women who are pregnant (as confirmed by urine pregnancy test performed at baseline), planning to become pregnant, or breast-feeding
    4. Any employee or family member of the Investigator, Johnson & Johnson, or the institution that has direct involvement with the trial or other trials under the direction of the Investigator or their staff members

    Psychiatric History:

    5. Clinical Global Impressions-Severity (CGI-S) less than 4 at the screening visit
    6. DSM IV criteria for any other Axis I diagnosis with the exception of nicotine dependence (use of tobacco or products containing tobacco is permitted)
    7. DSM IV criteria for substance or alcohol dependence within the past 6 months
    8. Use of cocaine or heroin within 3 months before the first administration of study drug
    9. Positive urine drug screen for cocaine, opiates, or amphetamines at the screening visit
    10. History of neuroleptic malignant syndrome or tardive dyskinesia/dystonia
    11. History of violence or, as deemed by the investigator, at imminent risk for harming others or damaging property
    12. History of attempted suicide within 12 months before study entry or, as deemed by the investigator, at imminent risk of suicide or self harm

    Treatment History:

    13. Hospitalized for psychotic symptoms within 4 weeks before first administration of study drug
    14. Hospitalized for psychotic symptoms or relapse more than 2 times within the past 6 months
    15. Established treatment-refractory schizophrenia as evidenced by any of the following:
    A. those who have had treatment failures or no clinical response despite adequate doses and duration of treatment with 2 antipsychotic drugs from different classes (failure to tolerate a medication does not count toward this definition), or
    B. previous treatment with clozapine for established treatment-refractory schizophrenia within the past 5 years, or
    C. hospitalization for psychotic symptoms for 4 or more times in the last 12 months, except for purely social reasons (e.g., food, housing, shelter, or respite care)
    16. History of hypersensitivity to paliperidone or risperidone
    17. Treatment history of failure to respond to risperidone or paliperidone
    18. History of any of the following disallowed therapies:
    A. treatment with any antipsychotic in addition to treatment with risperidone within 30 days before the baseline visit; or
    B. treatment with paliperidone within 30 days before the baseline visit; or
    C. treatment with depot antipsychotics, including long-acting injectable risperidone and paliperidone palmitate, within 3 months (90 days) of the screening visit; or
    D. any treatment with clozapine within the previous 60 days; or
    E. treatment with carbamazepine within 60 days before the baseline visit

    Medical History:

    19. History of significant neurological or medical disease
    20. History of seizure disorder and/or head injury
    21. Evidence of clinically significant or unstable cardiovascular, gastrointestinal, neurological, endocrine, metabolic, or pulmonary disease for the past 6 months that would increase the risk associated with taking study medication or would confound the interpretation of the study
    22. History or current evidence of any medical condition that could potentially alter gastrointestinal absorption (such as Crohn’s disease) or severe preexisting gastrointestinal narrowing (pathologic or iatrogenic)
    23. History or presence of circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval, including
    A. heart rate less than 50 beats per minute; or
    B. clinically relevant hypokalemia or hypomagnesemia; or
    C. concomitant use of other drugs that prolong the QTc interval (including Class 1A [e.g., quinidine, procainamide] or Class III [e.g., amiodarone, sotalol] antiarrhythmic medications, antipsychotic medications [e.g., chlorpromazine, thioridazine], antibiotics [e.g., gatifloxacin, moxifloxacin], or any other class of medications known to prolong the QTc interval); or
    D. presence of congenital prolongation of the QT interval.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measurement is the subject assessed Medication Satisfaction Questionnaire (MSQ) score.
    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 Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    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.8.4.1Number 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 EEA18
    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 study is considered completed with the last visit of the last subject undergoing the study.
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months9
    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) 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 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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 42
    F.4.2.2In the whole clinical trial 150
    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 Decision2008-01-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-06-18
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