NCT00073320

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at below P25 for phase_3 schizophrenia

Timeline
Completed

Started Aug 2003

Shorter than P25 for phase_3 schizophrenia

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2003

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
Last Updated

April 27, 2010

Status Verified

April 1, 2010

First QC Date

November 19, 2003

Last Update Submit

April 26, 2010

Conditions

Schizophrenia

Keywords

SchizophreniaPaliperidone palmitateR092670antipsychotic

Outcome Measures

Primary Outcomes (1)

  • To explore the comparability of pharmacokinetic parameter estimates of paliperidone and paliperidone palmitate between the 2 injection sites.

Secondary Outcomes (1)

  • Incidence of adverse events, labs and ECGs throughout study.

Interventions

Paliperidone PalmitateDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Schizophrenia

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

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

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 19, 2003

First Posted

November 21, 2003

Study Start

August 1, 2003

Study Completion

May 1, 2004

Last Updated

April 27, 2010

Record last verified: 2010-04