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Summary
EudraCT Number:2004-000326-70
Sponsor's Protocol Code Number:R076477-SCH-302/702
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:2004-06-29
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
A. Protocol Information
A.1Member State ConcernedCzechia - SUKL
A.2EudraCT number2004-000326-70
A.3Full title of the trial
A Randomized, 6-Week Double-Blind, Placebo-Controlled Study With an Optional 24-Week Open-Label Extension to Evaluate the Safety and Tolerability of Flexible Doses of Extended Release OROS® Paliperidone in the Treatment of Geriatric Subjects With Schizophrenia
A.3.2Name or abbreviated title of the trial where available
R076477-SCH-302/702 (INT-1)
A.4.1Sponsor's protocol code numberR076477-SCH-302/702
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, Johnson & Johnson spol. s.r.o.
B.1.3.4CountryCzech Republic
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 namepaliperidone 3 mg overencapsulated tablets
D.3.2Product code F022
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.3.9.2Current sponsor codeJNJ16232411, R076477
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 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 Information not present in EudraCT
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 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 namepaliperidone 9 mg overencapsulated tablets
D.3.2Product code F023
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.3.9.2Current sponsor codeJNJ16232411, R076477
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number9
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) Information not present in EudraCT
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 Information not present in EudraCT
D.IMP: 3
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 namepaliperidone 3 mg tablets
D.3.2Product code F016
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.3.9.2Current sponsor codeJNJ16232411, R076477
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) Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.3.2Gene therapy medical product Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.11Herbal medicinal product Information not present in EudraCT
D.3.11.12Homeopathic medicinal product Information not present in EudraCT
D.3.11.13Another type of medicinal product Information not present in EudraCT
D.IMP: 4
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 namepaliperidone 9 mg tablets
D.3.2Product code F0017
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.3.9.2Current sponsor codeJNJ16232411, R076477
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number9
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 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 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
Schizophrenia
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
The primary objective of the study is to evaluate the safety and tolerability of flexible doses of Extended Release (ER) OROS® paliperidone (3 to 12 mg/day) as compared with placebo in subjects with schizophrenia who are 65 years of age or older.
The primary objective of the open-label extension is the long-term assessment of safety and tolerability of ER OROS paliperidone (3 to 12 mg/day) in subjects diagnosed with schizophrenia.
E.2.2Secondary objectives of the trial
·Assess the global improvement in severity of illness associated with the use of ER OROS paliperidone compared with placebo
·Evaluate the benefits to the vitality and psychosocial domains of quality of life associated with the use of ER OROS paliperidone compared with placebo
·Assess the benefits to personal and social functioning associated with the use of ER OROS paliperidone compared with placebo
·Evaluate the improvement to sleep associated with the use of ER OROS paliperidone compared with placebo
·Explore the pharmacokinetics of ER OROS paliperidone and the relationship between pharmacokinetics and efficacy parameters, such as PANSS, and safety parameters of interest, such as extrapyramidal symptoms and other adverse events
·Determine genes/genotypes that may be related to the response to or metabolism of ER OROS paliperidone.
E.2.3Trial contains a sub-study Information not present in EudraCT
E.3Principal inclusion criteria
The subjects must satisfy the following criteria to be enrolled in R076477-SCH-302:
·65 years of age or older
·The subject signed an informed consent document indicating that the subject understands the purpose of, and procedures required for, the study and is willing to participate in the study
·The subject signed an informed consent document indicating that the subject agrees or does not agree to participate in the pharmacogenomic portion of the study. A subject who does not agree to have a DNA sample collected is still eligible to participate in the main portion of the study
·DSM-IV diagnosis of schizophrenia (295.10, 295.20, 295.30, 295.60, 295.90) at least 1 year before screening
·Total PANSS score at screening and baseline (Visit 2) between 70 and 120, inclusive
·Agrees to hospitalization for a minimum of 14 days and for the duration of the study, if clinically indicated

The final visit of the double-blind treatment phase (Visit 10) will serve as the first visit of the open-label treatment phase (Visit 101) A subject must meet the following criteria to continue in the open-label treatment phase of the study (R076477-SCH-702):
·Subject has completed 6 weeks of the double-blind treatment phase or finished at least 21 days and discontinued because of lack of efficacy
·Subject has signed the informed consent form for the open-label treatment phase
E.4Principal exclusion criteria
·A DSM-IV Axis I diagnosis other than schizophrenia
·A DSM-IV diagnosis of substance dependence within the 6 months before screening (nicotine and caffeine dependence are not exclusionary)
·Any medical condition that can potentially alter the absorption, metabolism, or excretion of the study drug such as Crohn’s disease, liver disease, or renal disease
·Relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine, or immunologic diseases
·History of tardive dyskinesia or neuroleptic malignant syndrome (NMS)·Known allergic reaction (rash) to phenytoin, carbamazepine, barbiturates, lamotrigine
·Other significant and/or unstable systemic illnesses
·Allergy or hypersensitivity to risperidone or paliperidone
·History of any severe preexisting severe gastrointestinal narrowing (pathologic or iatrogenic)
·Inability to swallow the study drug whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug, as this may affect the release profile)
·Previous history of a lack of response (2 adequate trials) to any antipsychotic
·Exposure to an experimental drug or experimental medical device within 90 days before screening
·Significant risk of suicidal or violent behavior
·Alanine aminotransferase or aspartate aminotransferase levels more than 2 times the upper limit of normal
·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
E.5 End points
E.5.1Primary end point(s)
The primary objective of the study is to evaluate safety and tolerability. This will be done through Adverse events listing and summarization. Clinical laboratory data and changes from baseline will be summarized. Changes noted in physical examinations, ECGs, and SAS, BARS, and AIMS will be summarized.
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 Information not present in EudraCT
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) Yes
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 Yes
E.8.1.7.1Other trial design description
The optional 24 weeks extension protocol (R076477-SCH-702) is open label
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 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 years1
E.8.9.1In the Member State concerned months3
E.8.9.1In the Member State concerned days
E.8.9.2In all countries concerned by the trial years1
E.8.9.2In all countries concerned by the trial months3
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) No
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 No
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 state20
F.4.2 For a multinational trial
F.4.2.1In the EEA 57
F.4.2.2In the whole clinical trial 105
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 Decision2004-08-11
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2004-06-17
P. End of Trial
P.End of Trial StatusCompleted

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