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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.

Register:	EUCTR
Last refreshed on:	19 March 2012
Main ID:	EUCTR2005-005343-26-FI
Date of registration:	03/02/2006
Prospective Registration:	Yes
Primary sponsor:	Janssen-Cilag International N.V.
Public title:	Open-Label Study to Evaluate the Safety and Pharmacokinetics of Single-and Multiple-Dose Extended-Release OROS Paliperidone in Pediatric Subjects (>/= 10 to
Scientific title:	Open-Label Study to Evaluate the Safety and Pharmacokinetics of Single-and Multiple-Dose Extended-Release OROS Paliperidone in Pediatric Subjects (>/= 10 to
Date of first enrolment:	17/03/2006
Target sample size:	82
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005343-26
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no
Phase:

Countries of recruitment
Finland

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
Subjects may be male or female and must be between 10 and 17 years of age, inclusive (subjects may become 18 during the study but must be 17 years of age on Day 1).

Subjects height and weight must be within the 5th to 95th Physical Growth National Center for Health Statistics percentiles for age and sex

Subjects must have a diagnosis of schizophrenia of any subtype (295.10; 295.20; 295.30; 295.60; 295.90), schizoaffective disorder (295.70), or schizophreniform disorder (295.40), according to the DSM-IV-TR.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Subjects with an active DSM-IV-TR axis I diagnosis other than schizophrenia, schizoaffective disorder, or schizophreniform disorder

Subjects with a history of DSM-IV-TR diagnosis of substance dependence within 6 months before screening (nicotine and caffeine dependence are not exclusionary)

Subjects who are involuntarily committed to psychiatric hospitalization

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder

Intervention(s)

Product Name: Paliperidone OROS 1mg ER system F053
Product Code: R076477
Pharmaceutical Form: Tablet
INN or Proposed INN: Paliperidone
Current Sponsor code: R076477
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-

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 OROS 6mg ER system F055
Product Code: R076477
Pharmaceutical Form: Tablet
INN or Proposed INN: Paliperidone
Current Sponsor code: R076477
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 6-

Primary Outcome(s)

Primary end point(s): The hypothesis of the study is that paliperidone ER will be well tolerated in children and adolescent subjects with schizophrenia, schizoaffective disorder, or schizophreniform disorder, and will display the expected PK characteristics in this population.

Main Objective: To characterize the pharmacokinetics of paliperidone after single-dose administration and at steady state following multiple oral administrations of paliperidone ER (using population PK modeling), in children and adolescent subjects (10 to 17 years of age) with schizophrenia, schizoaffective disorder, or schizophreniform disorder.

Secondary Objective: To evaluate the safety and tolerability of paliperidone ER in this subject population

Secondary Outcome(s)

Secondary ID(s)

PALIOROSPSZ1001

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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