- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00119756
A Safety and Tolerability Study of Paliperidone Palmitate Injected in the Shoulder or the Buttock Muscle in Patients With Schizophrenia
June 6, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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
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.
Study Overview
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
Study Type
Interventional
Enrollment (Actual)
253
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Safety evaluation (e.g. incidence of adverse events) between start and finish of the trial
|
Secondary Outcome Measures
Outcome Measure |
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Pharmacokinetic evaluations (e.g. blood level of the drug) at finish of trial; Efficacy measures at finish of trial
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Study Completion (ACTUAL)
November 1, 2006
Study Registration Dates
First Submitted
July 7, 2005
First Submitted That Met QC Criteria
July 7, 2005
First Posted (ESTIMATE)
July 14, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
June 8, 2011
Last Update Submitted That Met QC Criteria
June 6, 2011
Last Verified
April 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Paliperidone Palmitate
Other Study ID Numbers
- CR002350
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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