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Intramuscular Injections of Paliperidone Palmitate in the Arm or Buttock of Subjects With Schizophrenia

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ClinicalTrials.gov Identifier: NCT00073320
Recruitment Status : Completed
First Posted : November 21, 2003
Last Update Posted : April 27, 2010
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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).

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Paliperidone Palmitate Phase 3

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 to determine the similarity in pharmacokinetic (blood levels) and safety profile after 2 intramuscular injections of paliperidone palmitate in the arm (deltoid muscle) and the buttock (gluteal muscle), in the dose range that will be covered in later Phase 3 trials (25 - 150 mg eq.). This is a repeated-dose, open-label, parallel group study in patients with schizophrenia. The study consists of an up to 5-day screening period, an up to 3-day tolerability period, a 14-day washout period, and a 64-day treatment period. As paliperidone is the active metabolite of risperidone, all patients will be exposed to oral risperidone during the screening period to confirm that they do not develop allergic reactions to risperidone, and to help the investigator to assign patients to 1 of the 2 treatment doses. There will be a washout of at least 2 weeks after the last oral risperidone intake before patients receive the first injection of paliperidone palmitate. Each treatment group (arm or buttock injection) will receive 2 consecutive i.m. injections of the long-acting formulation of paliperidone palmitate with a one-week interval. Whole blood samples will be collected for the determination of paliperidone palmitate and paliperidone concentrations in plasma. Whole blood samples will be obtained by venipuncture (needle stick) immediately before (pre-dose) and at 4, 8, 12, 24, 48, 72, and 96 hours after the 1st and 2nd injections of paliperidone palmitate. Following the collection of the 96-hour blood sample after the 2nd injection, additional samples will be collected every 3 to 7 days through the end of the 64-day treatment period. Safety will assessed throughout the study by monitoring adverse events; changes in clinical laboratory results; tardive dyskinesia will be rated using the Abnormal Involuntary Movement Scale (AIMS), akathisia will be rated according to the Barnes Akathisia Rating Scale (BARS), extrapyramidal symptoms will be evaluated using the Simpson-Angus Rating Scale (SAS); physical examinations; electrocardiograms (ECGs); and patient evaluation of the injection site. Paliperidone palmitate (25 or 150 mg eq.), 2 i.m. doses administered at a 1-week interval. Depending on the randomized treatment group, each patient will receive 3 doses of oral risperidone: either 1 mg once daily for 3 days or 2 mg once on the 1st day, 4 mg once on the 2nd day, and 6 mg once on the 3rd day.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics, Tolerability, and Safety of Paliperidone After Repeated Intramuscular Injection of Paliperidone Palmitate in the Arm or the Buttock of Subjects With Schizophrenia
Study Start Date : August 2003
Actual Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia




Primary Outcome Measures :
  1. To explore the comparability of pharmacokinetic parameter estimates of paliperidone and paliperidone palmitate between the 2 injection sites.

Secondary Outcome Measures :
  1. Incidence of adverse events, labs and ECGs throughout study.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00073320


Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
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Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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ClinicalTrials.gov Identifier: NCT00073320     History of Changes
Other Study ID Numbers: CR004462
First Posted: November 21, 2003    Key Record Dates
Last Update Posted: April 27, 2010
Last Verified: April 2010

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Schizophrenia
Paliperidone palmitate
R092670
antipsychotic

Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Paliperidone Palmitate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents