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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: | NCT00791232 |
The purpose of this study is a noninferiority comparison of the orthostatic tolerability of a dose of 12 mg extened-release (ER) OROS paliperidone with the current recommended initial titration dose (2 mg) of immediate-release (IR) risperidone in patients with schizophrenia. Other study objectives are 1) to compare the tolerability and safety of a clinically equivalent fixed dose of ER OROS paliperidone with the currently recommended dose of risperidone, 2) to compare the early tolerability of the 2 treatments with placebo, 3) to compare tolerability of the 2 treatments, using a population pharmacokinteic/pharmacodynamic (pop PK/PD) model, to 4) assess the relationship between genetic variability in drug metabolizing enzymes and interindividual variability in plasma exposure to paliperidone or risperidone within each treatment group.
Condition | Intervention | Phase |
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Schizophrenia |
Drug: extended-release (ER) OROS paliperidone |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Pharmacodynamics Study |
Official Title: | A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, Phase 1 Study to Compare the Tolerability of OROS Paliperidone (Extended Release) With Immediate-Release (IR) Risperidone in Subjects With Schizophrenia |
Estimated Enrollment: | 120 |
Study Start Date: | March 2003 |
Study Completion Date: | June 2003 |
This is a randomized, double-blind, placebo- and active-controlled, parallel group, Phase 1. The study in patients with schizophrenia consists of a 1 week, open-label, placebo washout period (Days -7 to -1) and a 6 day double-blind treatment period during which patients will receive 1 of 3 treatments: placebo on Day 1 and ER OROS paliperidone (12 mg) on Days 2 to 6, ER OROS paliperidone (12 mg) on Days 1 to 6, or IR risperidone 2 mg on Day 1 and 4 mg on Days 2 to 6. Safety and tolerability will be monitored throughout the study..
ER OROS paliperidone (12 mg, oral) on Days 2 to 6, ER OROS paliperidone (12 mg, oral) on Days 1 to 6, or IR risperidone (oral) 2 mg on Day 1 and 4 mg on Days 2 to 6
Ages Eligible for Study: | 18 Years to 65 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: | CR004273 |
Study First Received: | November 13, 2008 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00791232 |
Health Authority: | United States: Food and Drug Administration |
Schizophrenia, Mood disorders, Antipsychotic drugs Extended-release paliperidone ER OROS paliperidone |
Schizophrenia Dopamine Mental Disorders Risperidone Mood Disorders |
9-hydroxy-risperidone Psychotic Disorders Serotonin Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents |