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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:
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EUCTR |
Last refreshed on:
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19 March 2012 |
Main ID: |
EUCTR2006-003560-62-CZ |
Date of registration:
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15/06/2007 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Randomized, Double-Blind, Parallel-Group, Comparative Study of Flexible
Doses of Paliperidone Palmitate and Flexible Doses of Risperidone Long-Acting
Intramuscular Injection in Subjects with Schizophrenia
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Scientific title:
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A Randomized, Double-Blind, Parallel-Group, Comparative Study of Flexible
Doses of Paliperidone Palmitate and Flexible Doses of Risperidone Long-Acting
Intramuscular Injection in Subjects with Schizophrenia |
Date of first enrolment:
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15/06/2007 |
Target sample size:
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1100 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-003560-62 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Austria
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Bulgaria
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Czech Republic
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Estonia
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France
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Germany
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Hungary
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Lithuania
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Spain
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Key inclusion & exclusion criteria
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Inclusion criteria: Men or women, aged at least 18 years old or the minimum age to provide informed consent in the jurisdiction in which the study is taking place, whichever is greater
Meet diagnostic criteria for schizophrenia according to DSM-IV (disorganized type [295.10], catatonic type [295.20], paranoid type [295.30], residual type [295.60], or undifferentiated type [295.90]) for at least 1 year before screening
A total PANSS score between 60 and 120, inclusive, at screening and baseline
Body mass index (BMI) at the screening visit BMI .17 kg/m2
Female subjects must be postmenopausal for at least 2 years, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before study entry and throughout the study. Effective methods of birth control include contraceptive pills, coil, depot injection of gestagen, subdermal implantation, hormonal vaginal ring, and transdermal depot patches. Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (ß-hCG) pregnancy test result at screening.
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: Unable to provide their own consent or involuntarily committed to psychiatric hospitalization
A primary, active DSM-IV diagnosis on Axis I other than schizophrenia
A DSM-IV diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary)
History of treatment resistance as defined by failure to respond to 2 adequate treatments with different antipsychotic medications (an adequate treatment is defined as a minimum of 6 weeks at maximum tolerated dosage)
Relevant history or current presence of any significant or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular disease), renal, hepatic, hematologic, endocrine, immunologic, morbid obesity (BMI >40 kg/m2), or other systemic disease
History of any severe pre-existing gastrointestinal narrowing (pathologic or iatrogenic) or inability to swallow oral study drug whole with the aid of water (applies to those subjects requiring oral tolerability only)
Serum chemistry, hematology, or urinalysis results that are not within the laboratory’s normal reference range and are deemed to be clinically significant by the investigator
History or evidence of clinically significant hepatic disease [including aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 times the upper limit of normal] at screening
History of neuroleptic malignant syndrome (NMS)
Significant risk of suicidal or violent behavior, as clinically assessed by the investigator
Subjects who have participated in 2 or more clinical trials in the past year, or in 1 clinical trial in the past 6 months (non-intervention, observational, and retrospective studies excluded)
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 MedDRA version: 9.1
Level: LLT
Classification code 10039626
Term: Schizophrenia
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Intervention(s)
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Trade Name: INVEGA Product Name: Paliperidone OROS 6mg extended release (ER) system Product Code: F040 Pharmaceutical Form: Tablet INN or Proposed INN: Paliperidone CAS Number: 144598-75-4 Current Sponsor code: R076477 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 6-
Product Name: Paliperidone Palmitate 100mg/ml nano suspension Product Code: R092670 (F013) Pharmaceutical Form: Solution for injection INN or Proposed INN: Paliperidone Palmitate CAS Number: 144598-75-4 Current Sponsor code: R092670 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intramuscular use
Product Name: Risperdal 1mg Tablets Product Code: F005 Pharmaceutical Form: Tablet INN or Proposed INN: Risperidone CAS Number: 106266-06-2 Current Sponsor code: R064766 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
Product Name: Risperdal CONSTA 25mg Product Code: F109 Pharmaceutical Form: Suspension for injection INN or Proposed INN: Risperidone CAS Number: 106266-06-2 Current Sponsor code: R064766 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intramuscular use
Product Name: Risperdal Consta 37.5mg Product Code: F109 Pharmaceutical Form: Suspension for injection INN or Proposed INN: Risperidone CAS Number: 106266-06-2 Current Sponsor code: R064766 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 37.5- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intramuscular use
Product Name: Risperidone CONSTA 50 mg Product Code: F109 Pharmaceutical Form: Suspension for injection INN or
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Primary Outcome(s)
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Primary end point(s): The primary endpoint is the change from baseline to endpoint in the total PANSS score. The change from the baseline score at each visit and at endpoint will be analyzed using an analysis of covariance (ANCOVA) model with factors for treatment and country, and baseline PANSS total score as the covariate. The calculation of the 95% confidence interval for the difference between risperidone LAI and paliperidone palmitate for the primary endpoint will be based on the 2-stage procedure described in Proschan et al. Noninferiority of paliperidone palmitate to risperidone LAI will be concluded if the lower limit of the 2-sided 95% confidence interval exceeds –5.
In addition to the per-protocol analysis set, additional analyses with the intent-to-treat analysis set (all randomized subjects who received at least 1 dose of double-blind study drug and have at least 1 efficacy measurement during the double-blind treatment period) will be performed to evaluate consistency of results.
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Main Objective: The primary objective of this study is to demonstrate that paliperidone palmitate is not less effective than risperidone LAI. The safety and tolerability of paliperidone palmitate in the treatment of schizophrenia will also be assessed.
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Secondary Objective: Assessment of the global improvement in severity of illness associated with the use of paliperidone palmitate compared with risperidone LAI
Explore the effects to personal and social functioning associated with the use of paliperidone palmitate compared with risperidone LAI
Explore the effects of paliperidone palmitate compared with risperidone LAI in improvement of sleep quality and reduction of daytime sleepiness
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Secondary ID(s)
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2006-003560-62-HU
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R092670PSY3006
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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