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.
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Risperidone long-acting injectable
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Risperidone, Long-acting injectable, Intramuscular injection, Pharmacokinetics
Eligibility Criteria
Inclusion Criteria:
- Chronic schizophrenia of any subtype, according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria
- stable schizophrenia without any changes in medications or dosage during the 4 weeks before the screening visit
- Clinical Global Impression scale score of <=3 (mild)
- informed consent signed by the patient
- patient is otherwise healthy on the basis of a prestudy physical examination and medical history.
Exclusion Criteria:
- No DSM-IV Axis I diagnosis other than schizophrenia
- no pregnant or breast feeding women
- no female subject of childbearing potential without adequate contraception
- no history of severe drug allergy or hypersensitivity
- no patients with inadequate mass in the gluteal or deltoid regions to receive the intramuscular drug injections.
Sites / Locations
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00843687
First Posted
February 12, 2009
Last Updated
June 2, 2011
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1. Study Identification
Unique Protocol Identification Number
NCT00843687
Brief Title
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.
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 Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
This is a randomized, open label, single dose, multicenter, 2-way crossover study comprising a screening phase, 2 open-label treatment periods, and end-of-study evaluations. The study population will comprise patients with chronic stable schizophrenia. Patients will be allowed to continue on their existing oral antipsychotic treatment throughout the study, if not receiving disallowed mediations, per protocol. Patients will be randomly allocated to receive treatment in 1 of 2 panels. In each panel, patients will receive a single intramuscular injection of long-acting injectable risperidone in each treatment period, in a 2-way crossover design. In Panel I, patients will receive 25 mg long-acting injectable risperidone via the gluteal muscle and 37.5 mg long-acting injectable risperidone via the deltoid muscle during the study period. In Panel II, patients will receive 50 mg long-acting injectable risperidone via the gluteal muscle and 50 mg long-acting injectable risperidone via the deltoid muscle. There will be a washout period of 85 days between each administration of study drug. The primary outcome will be comparison of the pharmacokinetic parameters area under the curve (AUC) and peak plasma concentration (Cmax) for 37.5 mg deltoid versus 25 mg gluteal, and for 50 mg deltoid versus 50 mg gluteal. Safety will be assessed at screening, throughout the open-label treatment phase, and at the end of study or early withdrawal using a combination of adverse events (including occurrence of extrapyramidal symptoms as assessed by the Extrapyramidal Symptoms Rating Scale), clinical laboratory tests (hematology, serum chemistry, urinalysis, and pregnancy testing), vital signs, physical examinations, electrocardiograms, and injection site evaluation. The study hypothesis is that intramuscular injections of long-acting injectable risperidone via the gluteal and deltoid sites will be bioequivalent routes of administration, as measured by peak and total drug concentrations in the plasma, and that the safety and tolerability profiles of the 2 injection sites will be comparable. The patients will receive a single injection of long--acting injectable risperidone (25 mg, 37.5 mg or 50 mg) in their gluteal or deltoid muscle in 2 treatment periods.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Risperidone, Long-acting injectable, Intramuscular injection, Pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Risperidone long-acting injectable
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic schizophrenia of any subtype, according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria
stable schizophrenia without any changes in medications or dosage during the 4 weeks before the screening visit
Clinical Global Impression scale score of <=3 (mild)
informed consent signed by the patient
patient is otherwise healthy on the basis of a prestudy physical examination and medical history.
Exclusion Criteria:
No DSM-IV Axis I diagnosis other than schizophrenia
no pregnant or breast feeding women
no female subject of childbearing potential without adequate contraception
no history of severe drug allergy or hypersensitivity
no patients with inadequate mass in the gluteal or deltoid regions to receive the intramuscular drug injections.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=724&filename=CR011023_CSR.pdf
Description
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.
Learn more about this trial
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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