Main
|
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:
|
7 October 2014 |
Main ID: |
EUCTR2005-005343-26-BE |
Date of registration:
|
01/02/2006 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
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 = 17 Years of Age) with Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder - Pediatric Subjects with Schizophrenia, Schizoaffective or Schizophreniform Disorder
|
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 = 17 Years of Age) with Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder - Pediatric Subjects with Schizophrenia, Schizoaffective or Schizophreniform Disorder |
Date of first enrolment:
|
08/03/2006 |
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
|
Belgium
|
Finland
| | | | | | |
Contacts
|
Name:
|
|
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
|
|
Name:
|
|
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
|
| |
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 ID(s)
|
PALIOROSPSZ1001
|
Source(s) of Monetary Support
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|