A Safety and Tolerability Study of Paliperidone Palmitate Injected in the Shoulder or the Buttock Muscle in Patients With Schizophrenia - Full Text View

Sponsored by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00119756

Purpose

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.

Condition	Intervention	Phase
Schizophrenia	Drug: paliperidone palmitate	Phase III

MedlinePlus related topics: Schizophrenia

Drug Information available for: Paliperidone Paliperidone Palmitate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Crossover Assignment, Safety/Efficacy Study
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

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

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

Estimated Enrollment:	282
Study Start Date:	June 2005
Study Completion Date:	November 2006

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119756

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director:

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

Study ID Numbers:	CR002350
Study First Received:	July 7, 2005
Last Updated:	March 17, 2008
ClinicalTrials.gov Identifier:	NCT00119756
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Schizophrenia
Paliperidone palmitate
Gluteus muscle
Intramuscular injection
Deltoid muscle

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Risperidone

9-hydroxy-risperidone
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009