A Comparison of the Pharmacokinetics and Safety of Long-acting Injectable Risperidone When Administered to Gluteal or Deltoid Intramuscular Injection Sites in Stable Schizophrenia Patients.
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|ClinicalTrials.gov Identifier: NCT00843687|
Recruitment Status : Completed
First Posted : February 13, 2009
Last Update Posted : June 9, 2011
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Risperidone long-acting injectable||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||188 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative Single-Dose Pharmacokinetics and Safety of Gluteal and Deltoid Intramuscular Injection of Long-Acting Injectable Risperidone in Subjects With Chronic Stable Schizophrenia|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||March 2007|
|Actual Study Completion Date :||March 2007|
- Comparison of the pharmacokinetic parameters AUC and Cmax for 37.5 mg deltoid versus 25 mg gluteal, and for 50 mg deltoid versus 50 mg gluteal based on blood sampling at predefined intervals up to 85 days.
- Patient-rated local site injection pain (measured on a visual analogue scale) & investigator-rated local site injection reaction (measured by injection site evaluation scale) measured 30 min. before injection & at regular intervals up to Day 15
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00843687
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|