Status:
COMPLETED
Intramuscular Injections of Paliperidone Palmitate in the Arm or Buttock of Subjects With Schizophrenia
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to compare the pharmacokinetic parameters (blood concentrations) of i.m. paliperidone palmitate after administration in 2 different injection sites (deltoid or gluteal).
Detailed Description
An i.m. paliperidone palmitate long-acting formulation is under development with the aim to provide a sustained and stable level of paliperidone during each treatment cycle. The goal of this study is ...
Eligibility Criteria
Inclusion
- Patients with a diagnosis of schizophrenia
- clinically stable with no change in current antipsychotic medications
- meet PANSS score criteria
- have a body mass index (BMI) between 15 and 35 kilogram (kg)/meter (m)2.
Exclusion
- Patients with DSM-IV diagnosis of alcohol or substance dependence, with the exception of nicotine or caffeine dependence
- involuntarily-committed
- have moderately severe or severe EPS symptoms
- history of malignant neuroleptic syndrome
- have current suicidal ideation or demonstrates violence
- current presence of any significant or unstable medication condition
- treatment with any protocol disallowed therapies
- clinically significant result from screening laboratory or ECG.
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2004
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00073320
Start Date
August 1 2003
End Date
May 1 2004
Last Update
April 27 2010
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