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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00119756

Enrollment

253

Registered

2005-07-14

Start date

2005-06-30

Completion date

2006-11-30

Last updated

2011-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Schizophrenia, Intramuscular injection, Deltoid muscle, Gluteus muscle, Paliperidone palmitate

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

Interventions

DRUGpaliperidone palmitate

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Safety evaluation (e.g. incidence of adverse events) between start and finish of the trial	—

Secondary

Measure	Time frame
Pharmacokinetic evaluations (e.g. blood level of the drug) at finish of trial; Efficacy measures at finish of trial	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026