Status:
COMPLETED
A Safety and Tolerability Study of Paliperidone Palmitate Injected in the Shoulder or the Buttock Muscle in Patients With Schizophrenia
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Schizophrenia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 evaluatin...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
253 Patients enrolled
Trial Details
Trial ID
NCT00119756
Start Date
June 1 2005
End Date
November 1 2006
Last Update
June 8 2011
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