Back to resultsA Safety and Tolerability Study of Paliperidone Palmitate Injected in the Shoulder or the Buttock Muscle in Patients With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
paliperidone palmitate
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Intramuscular injection, Deltoid muscle, Gluteus muscle, Paliperidone palmitate
Eligibility Criteria
Inclusion Criteria: The patient must have signed an informed consent The patient must meet the diagnostic criteria for schizophrenia Female patient must be postmenopausal for at least 2 years or have negative pregnancy test result at screening The patient must be able to perform study requirements (e.g. answer questionnaire) Exclusion Criteria: Primary, active diagnosis other than schizophrenia Psychiatric inpatient hospitalization for relapse of symptoms of schizophrenia in the past 90 days Change in their antipsychotic medication in the past 45 days Diagnosis of active substance dependence within 3 months History of treatment resistance History of concurrent significant or unstable diseases (e.g. heart, lung, or liver diseases)
Sites / Locations
Outcomes
Primary Outcome Measures
Safety evaluation (e.g. incidence of adverse events) between start and finish of the trial
Secondary Outcome Measures
Pharmacokinetic evaluations (e.g. blood level of the drug) at finish of trial; Efficacy measures at finish of trial
Full Information
NCT ID
NCT00119756
First Posted
July 7, 2005
Last Updated
June 6, 2011
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1. Study Identification
Unique Protocol Identification Number
NCT00119756
Brief Title
A Safety and Tolerability Study of Paliperidone Palmitate Injected in the Shoulder or the Buttock Muscle in Patients With Schizophrenia
Official Title
A Randomized, Crossover Study to Evaluate the Overall Safety and Tolerability of Paliperidone Palmitate Injected in the Deltoid or Gluteus Muscle in Patients With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (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 evaluate the safety and tolerability of intramuscular injections (to the buttocks or to the shoulders) of paliperidone palmitate in patients with schizophrenia.
Detailed Description
To date, all prior trials involving intramuscular injection of paliperidone palmitate were conducted with buttock administration. This is a randomized, multicenter, crossover design study in evaluating safety and tolerability of paliperidone palmitate in two different injection sites. The study hypothesis is that there will be no difference in safety and tolerability between buttock injection compared to shoulder injection at any of the three different doses of paliperidone palmitate. The patients will receive intramuscular injections of paliperidone palmitate in either their buttocks or in their shoulders
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Intramuscular injection, Deltoid muscle, Gluteus muscle, Paliperidone palmitate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
253 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
paliperidone palmitate
Primary Outcome Measure Information:
Title
Safety evaluation (e.g. incidence of adverse events) between start and finish of the trial
Secondary Outcome Measure Information:
Title
Pharmacokinetic evaluations (e.g. blood level of the drug) at finish of trial; Efficacy measures at finish of trial
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient must have signed an informed consent
The patient must meet the diagnostic criteria for schizophrenia
Female patient must be postmenopausal for at least 2 years or have negative pregnancy test result at screening
The patient must be able to perform study requirements (e.g. answer questionnaire)
Exclusion Criteria:
Primary, active diagnosis other than schizophrenia
Psychiatric inpatient hospitalization for relapse of symptoms of schizophrenia in the past 90 days
Change in their antipsychotic medication in the past 45 days
Diagnosis of active substance dependence within 3 months
History of treatment resistance
History of concurrent significant or unstable diseases (e.g. heart, lung, or liver diseases)
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
Citations:
PubMed Identifier
19481579
Citation
Hough D, Lindenmayer JP, Gopal S, Melkote R, Lim P, Herben V, Yuen E, Eerdekens M. Safety and tolerability of deltoid and gluteal injections of paliperidone palmitate in schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2009 Aug 31;33(6):1022-31. doi: 10.1016/j.pnpbp.2009.05.014. Epub 2009 May 28.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=469&filename=CR002350_CSR.pdf
Description
A safety and tolerability study of paliperidone palmitate injected in the deltoid or the gluteal muscle in patients with schizophrenia
Learn more about this trial
A Safety and Tolerability Study of Paliperidone Palmitate Injected in the Shoulder or the Buttock Muscle in Patients With Schizophrenia
We'll reach out to this number within 24 hrs