Injection Site Tolerability of Multiple Dose Treatment With Long-acting Injectable Risperidone Administered Via Deltoid Muscle in Chronic Schizophrenia Patients.
|ClinicalTrials.gov Identifier: NCT00828958|
Recruitment Status : Completed
First Posted : January 26, 2009
Last Update Posted : May 18, 2011
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Risperidone long-acting injectable||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Local Site Tolerability of Multiple Dose Treatment With Deltoid Intramuscular Injection of RISPERDAL CONSTA in Subjects With Chronic Schizophrenia.|
|Study Start Date :||February 2006|
|Study Completion Date :||September 2006|
- The proportion of patients who discontinued from the study after having received at least 2 deltoid injections will be recorded.
- Reasons for discontinuation, patient rated local site injection pain and investigator rated local site injection reaction will be assessed at predefined times throughout the study.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00828958
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|