- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00796081
A Safety and Pharmacokinetic Study of ER OROS Paliperidone in Pediatric Patients With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder
June 6, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Open-label Study to Evaluate the Safety and Pharmacokinetics of Single- and Multiple-dose Extended-release OROS Paliperidone in Pediatric Subjects (=10 to =17 Years of Age) With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder
The purposes of this study are to characterize the pharmacokinetics of paliperidone after single- and multiple-dose administration of paliperidone ER in children and adolescent patients (>= 10 to <= 17 years of age) with schizophrenia, schizoaffective disorder, or schizophreniform disorder and to evaluate the safety and tolerability of paliperidone ER in this patient population.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The current study is designed as a multicenter, open-label, multiple-dose study in children and adolescent patients >= 10 to <= 17 years of age with schizophrenia, schizoaffective disorder, or schizophreniform disorder.
The study includes 3 dosage groups (0.086, 0.129, and 0.171 mg/kg/day paliperidone ER), which will be studied in a sequential ascending design, so that the safety of the drug can be properly evaluated with a lower dosage before proceeding to the next higher dosage.
The 3 dosages are approximately 6, 9, and 12 mg/day in adults.
Within each dosage group, patients will be randomly assigned to 1 of 2 pharmacokinetic sampling schedules in a 1:1 ratio.
For each dosage group, the study consists of a screening phase (for a maximum of 21 days); a 2-day, single-dose pharmacokinetic and tolerability evaluation phase; a 7-day multiple-dose phase, with evaluation of pharmacokinetics and tolerability; and an end-of-study visit.
Following the completion of all patients in a given dosage group, the sponsor will evaluate the safety and tolerability of the treatment, in order to determine whether to proceed to the next higher or lower dosage level.
The first group will start at 0.086 mg/kg/day.
The hypothesis is that paliperidone ER will be well tolerated in children and adolescent patients with schizophrenia, schizoaffective disorder, or schizophreniform disorder, and will display the expected pharmacokinetic characteristics in this population.
Paliperidone ER 0.086, 0.129, and 0.171 mg/kg/day, oral administration, single dose on Day 1 of study followed by once daily dosing on Days 3 to 9.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 17 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients' height and weight must be within the 5th to 95th Physical Growth National Center for Health Statistics percentiles for age and sex
- Patients must have a diagnosis of schizophrenia of any subtype (295.10
- 295.20
- 295.30
- 295.60
- 295.90), schizoaffective disorder (295.70), or schizophreniform disorder (295.40), according to the DSM-IV-TR
- Patients must be healthy (other than the DSM-IV-TR classification), on the basis of the screening medical history, physical examination, 12-lead ECG, and clinical laboratory tests (hematology, serum chemistry, and urinalysis). Patients with laboratory results outside the normal reference range can be included only if the investigator, upon consultation with the sponsor, judges the deviations as not clinically significant
- QT values must be within normal limits and patients must have a CGI-S score of less than or equal to 3
- Female patients must be premenarchal, 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) for at least 1 month before study entry and throughout the study, have a negative serum beta-human chorionic gonadotropin pregnancy test at screening, and a negative urine pregnancy test on Day 1
- Patients must sign an informed assent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study, with Parent(s) or the legal guardian(s) of each patient signing an informed consent document indicating that they understand the purpose of and the procedures required for the study and give permission for their child's participation in the study and a responsible person must be available to accompany the patient to the investigational site at each visit
- Patients must agree to be hospitalized at any time during the study, and their parent(s) or legal guardian(s) must consent, if it is deemed clinically necessary by the investigator.
Exclusion Criteria:
- Patients with an active DSM-IV-TR axis I diagnosis other than schizophrenia, schizoaffective disorder, or schizophreniform disorder
- Patients with a history of DSM-IV-TR diagnosis of substance dependence within 6 months before screening (nicotine and caffeine dependence are not exclusionary) or patients who are involuntarily committed to psychiatric hospitalization
- Patients with a significant risk of suicidal or violent ideation or behavior, as judged by the clinical investigator
- Female patients who are pregnant, who plan to become pregnant during the study, or who are breast-feeding
- Patients with any medical condition that can potentially alter the absorption, metabolism, or excretion of the study drug (e.g., Crohn's disease, severe gastrointestinal narrowing [pathologic or iatrogenic], liver disease, or renal disease)
- Patients with a history of any malignancy, with the exception of basal cell carcinoma, in the past 5 years
- Patients with a history of a positive result for any serology test (e.g., human immunodeficiency virus, hepatitis), with a history of neuroleptic malignant syndrome
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
to characterize the pharmacokinetics of paliperidone after single- and multiple-dose oral administrations of paliperidone ER in children and adolescent patients (>= 10 to <= 17 years of age)
|
Secondary Outcome Measures
Outcome Measure |
---|
to evaluate the safety and tolerability of paliperidone ER in this patient population
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Study Completion (ACTUAL)
August 1, 2006
Study Registration Dates
First Submitted
November 20, 2008
First Submitted That Met QC Criteria
November 20, 2008
First Posted (ESTIMATE)
November 24, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
June 8, 2011
Last Update Submitted That Met QC Criteria
June 6, 2011
Last Verified
March 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Disease
- Psychotic Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Paliperidone Palmitate
Other Study ID Numbers
- CR002371
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Schizophrenia
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Bradley LegaRecruiting
-
All India Institute of Medical Sciences, BhubaneswarRecruitingTreatment Resistant SchizophreniaIndia
-
King's College LondonSouth London and Maudsley NHS Foundation TrustRecruitingTreatment-resistant Schizophrenia | Healthy Controls | Treatment-responsive SchizophreniaUnited Kingdom
-
University of Sao PauloUnknownRefractory Schizophrenia | Super Refractory SchizophreniaBrazil
-
Peking UniversityNot yet recruitingTreatment-resistant Schizophrenia
-
Ohio State UniversityRecruitingTreatment-resistant SchizophreniaUnited States
-
University Hospital, BrestRecruitingSchizophrenia | Schizophrenia Prodromal | Schizophrenia, ChildhoodFrance
-
NYU Langone HealthNot yet recruitingTreatment-resistant SchizophreniaUnited States
Clinical Trials on ER OROS paliperidone, paliperidone ER
-
Watson PharmaceuticalsCompletedAnemia, Iron-Deficiency | Hemodialysis | Kidney Failure, ChronicUnited States
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedSchizophrenia | Renal Impairment
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedSchizophrenia
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Johnson & Johnson Pharmaceutical Research & Development...Completed