Comparative Single-Dose Pharmacokinetics and Safety of Gluteal and Deltoid Intramuscular Injection of Long-Acting Injectable Risperidone in Subjects With Chronic Stable Schizophrenia
Sponsor study identifier
interventional
188
0 countries
N/A
Study Start
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2007
Actual (reported)Study Completion
March 2007
Actual (reported)The purpose of this study is to compare the pharmacokinetics and safety of long-acting injectable risperidone, an atypical antipsychotic medication used for the treatment of patients with schizophrenia, when it is administered as an intramuscular injection via the deltoid muscle, compared with intramuscular injection via the gluteal muscle.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2007
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
March 2007
Actual (reported)March 2007
Actual (reported)February 12, 2009
Actual (reported)February 13, 2009
Actual (reported)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
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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
188 participants (actual enrollment reported by the registry).
First Submitted
February 12, 2009
First Posted
February 13, 2009
Study Start
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
Investigate Risperidone for the Treatment of Schizophrenia in Adolescents
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Primary Completion
March 2007
Actual (reported)Study Completion
March 2007
Actual (reported)Last Updated
June 9, 2011
Record last verified: 2011-06
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Source: ClinicalTrials.gov.
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