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

03:25 EDT 31st July 2014 | BioPortfolio

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).

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Schizophrenia

Intervention

Paliperidone Palmitate

Status

Completed

Source

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

Results (where available)

View Results

Links

Clinical Trials [633 Associated Clinical Trials listed on BioPortfolio]

A Safety and Pharmacokinetic Study of Paliperidone Palmitate in Patients With Schizophrenia

The purpose of this study is to evaluate the long-term safety of flexible doses (50 to 150 mg equivalent) of paliperidone palmitate in the treatment of patients with schizophrenia and to d...

A Safety and Tolerability Study of Paliperidone Palmitate Injected in the Shoulder or the Buttock 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 schizophre...

A Study to Compare the Effectiveness and Safety of Flexibly Varied Doses of Paliperidone Palmitate and Risperidone in Treating Patients With Schizophrenia

The purpose of this study is to compare the effectiveness and safety over 1 year of treatment of intramuscular injections of paliperidone palmitate and long-acting risperidone in patients...

A Study of Paliperidone Blood Concentrations in Patients With Schizophrenia After Administration of Paliperidone Palmitate

The purpose of this study is to evaluate the concentration of paliperidone in the blood after intramuscular injection in upper arm (deltoid muscle) or in the buttock (gluteal muscle) in pa...

Comparison of Paliperidone Palmitate and Risperdal Consta in Patients With Schizophrenia

The primary objective of this study is to demonstrate that the effectiveness of paliperidone palmitate in patient with Schizophrenia.

PubMed Articles [884 Associated PubMed Articles listed on BioPortfolio]

Maintenance treatment of schizophrenia with paliperidone palmitate (xeplion): a naturalistic study.

The efficacy of injectable form of paliperidone palmitate was studied in a sample of 14 schizophrenic patients (6 men and 8 women, mean age 33.8 years). Paliperidone palmitate was used as maintenance...

Influencing Factors and Predictors of Early Response in Schizophrenia Patients Receiving the Paliperidone Extended-Release Tablets (Paliperidone ER).

Paliperidone extended-release tablet (paliperidone ER) is a new oral psychotropic agent developed for schizophrenia treatment. There have been some studies about paliperidone's good efficacy and toler...

Effects of paliperidone palmitate on coagulation: an experimental study.

Objective. The aim of the present study was to examine the effects of a new antipsychotic drug paliperidone palmitate on hemogram and coagulation parameters in rats. Materials and Methods. Experiments...

Efficacy and metabolic influence of paliperidone ER, aripiprazole and ziprasidone to patients with first-episode schizophrenia through 52 weeks follow-up in China.

There are no direct comparisons of paliperidone extended-release (ER), aripiprazole and ziprasidone in efficacy and metabolic influence in patients with first-episode schizophrenia.

Efficacy and Safety of Combined Paliperidone Palmitate and Olanzapine Pamoate in Resistant Schizoaffective Disorder.

Medical and Biotech [MESH] Definitions

A chronic form of schizophrenia characterized primarily by the presence of persecutory or grandiose delusions, often associated with hallucination.

A type of schizophrenia characterized by abnormality of motor behavior which may involve particular forms of stupor, rigidity, excitement or inappropriate posture.

An obsolete concept, historically used for childhood mental disorders thought to be a form of schizophrenia.

Enzyme catalyzing reversibly the hydrolysis of palmitoyl-CoA or other long-chain acyl coenzyme A compounds to yield CoA and palmitate or other acyl esters. The enzyme is involved in the esterification of fatty acids to form triglycerides. EC 3.1.2.2.

A type of schizophrenia characterized by frequent incoherence; marked loosening of associations, or grossly disorganized behavior and flat or grossly inappropriate affect that does not meet the criteria for the catatonic type; associated features include extreme social withdrawal, grimacing, mannerisms, mirror gazing, inappropriate giggling, and other odd behavior. (Dorland, 27th ed)

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