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| Sponsor: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
|---|---|
| Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT00074477 |
Purpose
The purpose of this study is to determine the efficacy (how well the drug works), safety, and side effects of paliperidone palmitate injection compared to placebo in the treatment of the symptoms of schizophrenia in adults. The placebo used in this study was a nutritional substance known as 20% Intralipid emulsion given to patients requiring intravenous feedings.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: R092670 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 50 and 100 Mg-eq of Paliperidone Palmitate in Patients With Schizophrenia |
| Enrollment: | 250 |
| Study Start Date: | October 2003 |
| Study Completion Date: | July 2004 |
Paliperidone palmitate is an aqueous suspension that releases paliperidone gradually over a period of about 1 month and is under development to provide a sustained and stable level of paliperidone. This is a randomized (patients will be assigned to different treatment groups based solely on chance), double-blind (neither the patient nor the physician will know if placebo or drug is being given and at what dose), placebo-controlled, multicenter study in patients with schizophrenia. The study consists of a screening period (maximum 5 days, including a 3-day washout of psychotropic medications other than antidepressants, if applicable); a 7-day, open-label, oral run-in period; and a 64-day double-blind treatment period. The total duration of the study is approximately 11 weeks. Efficacy will be evaluated during the study using the Positive and Negative Symptom Scale for Schizophrenia (PANSS) and the Clinical Global Impression - Severity (CGI-S) scale. Safety will be evaluated by monitoring adverse events and changes in clinical laboratory results, including prolactin levels; physical examination results; tardive dyskinesia will be rated using the Abnormal Involuntary Movement Scale (AIMS), akathisia will be rated according to the Barnes Akathisia Rating Scale (BARS), extrapyramidal symptoms will be evaluated using the Simpson-Angus Rating Scale (SAS); electrocardiogram (ECG); vital sign measurements; and concomitant therapy. ER OROS paliperidone (6 or 12 mg) or IR paliperidone (2 or 4 mg) oral dosage administered daily for 7 days (Day -7 to -1), followed by i.m. injections of paliperidone palmitate (either 50 mg eq. or 100 mg eq.), or placebo on Days 1, 8, and 36 of the study.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
| Study ID Numbers: | CR004357 |
| Study First Received: | December 12, 2003 |
| Last Updated: | August 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00074477 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Schizophrenia Paliperidone palmitate R092670 antipsychotic |
|
Schizophrenia Tranquilizing Agents Mental Disorders Therapeutic Uses Physiological Effects of Drugs Psychotropic Drugs |
Central Nervous System Depressants 9-hydroxy-risperidone Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions Schizophrenia and Disorders with Psychotic Features |