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Tracking Information | |||||
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First Received Date † | June 2, 2006 | ||||
Last Updated Date | October 10, 2008 | ||||
Start Date † | April 2006 | ||||
Current Primary Outcome Measures † |
Reduction in total PANSS ( Positive and Negative Syndrome Scale) from baseline to endpoint at Day 14 | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00334126 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Time to response (based on reduction in PANSS plus Clinical Global Impression - Change) and readiness for discharge, utilization of health care resources and polypharmacy use in patients receiving paliperidone ER or quetiapine | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Evaluation of Effectiveness and Safety of Paliperidone ER (Extended-Release) Compared With Quetiapine in Patients With Schizophrenia | ||||
Official Title † | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Paliperidone ER Compared to Quetiapine in Subjects With an Acute Exacerbation of Schizophrenia | ||||
Brief Summary | The purpose of this study is to evaluate the efficacy (effectiveness of drug) and safety of the antipsychotic paliperidone ER compared to another antipsychotic, quetiapine, and to placebo in patients who are acutely ill with symptoms of schizophrenia. |
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Detailed Description | This is a randomized (patients are assigned different treatments based on chance), double blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), placebo controlled, parallel group study to compare the efficacy and safety of paliperidone ER with quetiapine in the treatment of patients who have schizophrenia and are acutely ill. The duration of the study is 42 days. During the first phase (Day 0 - Day 14) patients receive increasing doses of the treatment to which they are assigned (starting with 3mg and increasing to 9 mg or 12 mg of paliperidone ER; starting with 50 mg and increasing to 600 mg or 800 mg of quetiapine; or the same number of capsules of placebo). During the second phase (Day 15 - Day 42), patients continue to take the dose of medication they received on day 14, but may also receive other medications if the investigator determines they are needed to treat ongoing symptoms. The hypothesis of the study is that paliperidone ER is better than quetiapine in the short term for treating acutely ill patients with schizophrenia. Primary outcome is change on the total score of the PANSS (Positive and Negative Syndrome scale for Schizophrenia) in the first phase of the study (Day 0 - Day 14). Secondary outcomes include time to response, time to readiness for discharge, and additional medication use in the second phase of the study (Day 15- Day 42) for patients receiving paliperidone ER compared to quetiapine. Safety of paliperidone ER compared with quetiapine throughout the study (Day 0 - Day 42) will be based on reported adverse events, results of laboratory tests (hematology, biochemistry, and urinalysis), vital signs (blood pressure, pulse, and weight), electrocardiogram, and movement disorder scales (Abnormal Involuntary Movement Scale, Barnes Akathisia Scale, and Simpson-Angus Rating Scale). Patients may participate in a pharmacogenomic (DNA) analysis, if they choose to do so. Patients receive study drug by mouth for a total of 42 days. Study medications will be increased to maximum tolerated doses of Paliperidone ER 9mg or 12mg/day and Quetiapine 600mg or 800mg at day 8. From day 15 through day 42 (end of study) all patients will be eligible for additional psychotropic medications at investigators' discretion. |
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Study Phase | Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study | ||||
Condition † | Schizophrenia | ||||
Intervention † | Drug: paliperidone ER tablets, quetiapine tablets, placebo - all overencapsulated | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 395 | ||||
Completion Date | September 2007 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 65 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | |||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00334126 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | ||||
Collaborators †† | Janssen, LP | ||||
Investigators † |
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Information Provided By | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | ||||
Verification Date | October 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |