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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: | NCT00589914 |
The primary objective of this study is to demonstrate that the effectiveness of paliperidone palmitate in patient with Schizophrenia.
Condition | Intervention | Phase |
---|---|---|
Schizophrenia |
Drug: Paliperidone Palmitate Drug: RISPERDAL CONSTA |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Parallel-Group, Comparative Study of Flexible Doses of Paliperidone Palmitate and Flexible Doses of Risperidone Long-Acting Intramuscular Injection in Subjects With Schizophrenia |
Estimated Enrollment: | 700 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | March 2009 |
Arms | Assigned Interventions |
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001: Experimental |
Drug: Paliperidone Palmitate
50-150 mg eq every 4 wks
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002: Active Comparator |
Drug: RISPERDAL CONSTA
25-50 mg eq every 2 weeks
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The primary hypothesis is that at the endpoint of the study (Week 13), paliperidone palmitate is noninferior to RISPERDAL CONSTA in the treatment of schizophrenia as defined by the upper limit of the confidence interval (CI) of the difference between RISPERDAL CONSTA and paliperidone palmitate on change in total Positive and Negative Syndrome Scale (PANSS) score not exceeding 5 points.This is a randomized, double-blind, double-dummy, active-controlled, parallel-group, multicenter, comparative study in approximately 700 men and women (350 in each arm) aged 18 years or older who meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for schizophrenia for at least 1 year, a total PANSS score of 60 to 120, inclusive. Secondary objectives include the following: Assessment of the global improvement in severity of illness associated with the use of paliperidone palmitate compared with RISPERDAL CONSTA, Examining the effects to personal and social functioning associated with the use of paliperidone palmitate compared with RISPERDAL CONSTA, Examine the effects of paliperidone palmitate compared with RISPERDAL CONSTA in improvement of sleep quality and reduction of daytime sleepiness The study consists of 2 periods: a 7-day screening/washout period and a 13-week double-blind treatment period. The screening period will include up to 7 days for the washout of previous disallowed psychotropic medications and up to 6 days for oral tolerability testing with paliperidone extended release (ER), if necessary. Washout and tolerability testing may overlap. During the treatment period, patients will be randomized in a 1 to 1 ratio to receive either paliperidone palmitate or RISPERDAL CONSTA. Doses may be adjusted depending on efficacy or tolerability. End of study/early withdrawal assessments will be done 2 weeks after the last dose of study drug (Day 92) for all patients completing the study. For patients withdrawing from the study early, end-of-study/early withdrawal assessments will be done at the time of withdrawal. The total duration of the study will be approximately 14 weeks.Safety, tolerability, efficacy, and exploratory assessments will be done periodically throughout the study. A pharmacogenomic blood sample will be collected from patients who give a separate, written informed consent for this part of the study (where local regulations permit). This will allow for pharmacogenomic research, as necessary. Participation in pharmacogenomic research is optional.
Paliperidone palmitate will be administered using a dosing regimen that includes an initial i.m. injection of paliperidone palmitate 150 mg eq. at baseline, a second injection of 100 mg eq. paliperidone palmitate at Visit 4 (Day 8), and subsequent injections of paliperidone palmitate every 4 weeks, at Visit 7 (Day 36) and Visit 9 (Day 64). Depending on tolerability and efficacy, the investigator will be permitted to flexibly dose paliperidone palmitate.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | info1@veritasmedicine.com |
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Responsible Party: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. ( Compound Development Team Leader, Paliperidone ) |
Study ID Numbers: | CR012289, R092670PSY3006 |
Study First Received: | December 21, 2007 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00589914 |
Health Authority: | United States: Food and Drug Administration |
long-acting injectable antipsychotic medication Schizophrenia |
Schizophrenia Dopamine Mental Disorders Risperidone |
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 |