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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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21 August 2023 |
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Main ID: |
EUCTR2005-001845-40-CZ |
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Date of registration:
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13/10/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Randomized, Crossover Study to Evaluate the Overall Safety and Tolerability of Paliperidone Palmitate Injected in the Deltoid or Gluteus Muscle in Subjects With Schizophrenia - Safety and tolerability of paliperidone palmitate in schizophrenia - deltoid vs gluteal injection.
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Scientific title:
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A Randomized, Crossover Study to Evaluate the Overall Safety and Tolerability of Paliperidone Palmitate Injected in the Deltoid or Gluteus Muscle in Subjects With Schizophrenia - Safety and tolerability of paliperidone palmitate in schizophrenia - deltoid vs gluteal injection. |
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Date of first enrolment:
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18/10/2005 |
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Target sample size:
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270 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001845-40 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: 50, 75, or 100mg
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Czech Republic
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Germany
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Slovakia
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Key inclusion & exclusion criteria
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Inclusion criteria:
18 or older; consented;stable schizophrenia (PANSS <=70);BMI>=17kg/m2;able to perform study requirements
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
psychiatric hospitalization in last 90 days;change in antipsychotic dose in last 45 days;active substance dependence;treatment resistance history;relevant history or currren significant or unstable systemic disease;severe allergy or hypersensitivity to study drug,treatment with disallowed meds
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Schizophrenia according to DSM-IV-TM [disorganized type (295.10), catatonic type (295.20), paranoid type (295.30), residual type (295.60) or undifferentiated type (295.90)]
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Intervention(s)
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Product Name: Paliperidone OROS 3mg extended release (ER) system
Product Code: F016
Pharmaceutical Form: Tablet
INN or Proposed INN: Paliperidone
Current Sponsor code: R076477
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
Product Name: Paliperidone Palmitate 100 mg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: paliperidone palmitate
Current Sponsor code: R092670
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Product Name: Paliperidone Palmitate 50 mg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: paliperidone palmitate
Current Sponsor code: R092670
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Product Name: Paliperidone Palmitate 75 mg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: paliperidone palmitate
Current Sponsor code: R092670
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
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Primary Outcome(s)
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Main Objective: The primary objectives of this study are to evaluate the safety and tolerability of:
a). the deltoid muscle injection site for initiating treatment with any of 3 doses of paliperidone palmitate (50, 75, and 100 mg eq.) in subjects with schizophrenia.
·b). switching from the gluteal to the deltoid injection site and from the deltoid to the gluteal injection site at therapeutic plasma concentrations with 3 doses of paliperidone palmitate (50, 75, and 100 mg eq.) in subjects with schizophrenia.
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Primary end point(s): Tolerance of initiation evaluation based on a between group comparison of the incidence of systemic adverse events occurring between the first injection and Week 13 in subjects receiving deltoid injections versus subjects receiving gluteal injections. Tolerance of switching evaluation ased on a within-subject comparison of incidence of systemic adverse events occurring during the last 2 injection intervals (8 weeks) of each treatment period
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Secondary Objective: The exploration of the pharmacokinetics of paliperidone after intramuscular (i.m.) administration of paliperidone palmitate using the injection site as a covariate and the relationship between its pharmacokinetics and the results of safety parameters of interest.
·An evaluation of the incidence of systemic adverse events that occur or worsen during the last 2 injection cycles (8 weeks) of the study.
·Assessment of the overall safety and tolerability of paliperidone palmitate
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Secondary ID(s)
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R092670-PSY-3005
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2005-001845-40-DE
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 21/09/2005
Contact:
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