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Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00796081 |
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.
Condition | Intervention | Phase |
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Schizoaffective Disorder Schizophrenia Schizophreniform Disorders |
Drug: ER OROS paliperidone, paliperidone ER |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study |
Official Title: | 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 |
Estimated Enrollment: | 24 |
Study Start Date: | January 2006 |
Study Completion Date: | August 2006 |
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.
Ages Eligible for Study: | 10 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Study ID Numbers: | CR002371 |
Study First Received: | November 20, 2008 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00796081 |
Health Authority: | United States: Food and Drug Administration |
Pediatrics Schizoaffective disorder Schizophrenia Antipshychotic drugs |
Schizophreniform disorders ER OROS Paliperidone, Paliperidone ER Mood disorders |
Schizophrenia Mental Disorders Risperidone Mood Disorders |
9-hydroxy-risperidone Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Tranquilizing Agents Pathologic Processes Disease Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions |