A Study of Extended Release Extended-release (ER) OROS Paliperidone Tolerability, as Compared to Immediate-release (IR)Risperidone, in Patients With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
extended-release (ER) OROS paliperidone
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Extended-release paliperidone, Schizophrenia, Mood disorders, Antipsychotic drugs, ER OROS paliperidone
Eligibility Criteria
Inclusion Criteria:
- Willingness to spend 2 weeks as an in-patient during the washout and treatment period
- Currently treated with oral risperidone antipsychotic monotherapy for at least 1 month prior to screening
- DSM-IV diagnosis of schizophrenia (Patients with a diagnosis of schizophrenia [paranoid type (295.30), disorganized type (295.10), catatonic type (295.20), undifferentiated type (295.90), or residual type (295.60)] as defined by DSM-IV criteria
- Absence of acute exacerbation for a minimum of 6 months prior to screening
- Female patients must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before screening and throughout the study, and have a negative urine pregnancy test at screening and baseline
- The patient is otherwise healthy on the basis of a physical examination, medical history, electrocardiogram, and the results of blood biochemistry and hematology tests and a urinalysis performed within 30 days of the start of the treatment period. If the results of the biochemistry or hematology tests or the urinalysis testing are not within the laboratory's reference ranges, the patient may be included only on condition that the investigator judges that the deviations are not clinically significant.
Exclusion Criteria:
- Involuntarily committed in-patients
- Patients who have received long-acting depot antipsychotic medication (discontinued RISPERDAL CONSTA for less than 10 weeks or discontinued other depots for less than 2 cycles)
- Any significant history of cardiovascular disease: atrial fibrillation or flutter, second and third degree heart block and equivalent, resting supraventricular tachycardia (>100 beats per minute), unstable atherosclerotic heart disease, valvular abnormality
- Body Mass Index > = 35 kg/m2 or a history of or current hypertension
- Use of disallowed concomitant therapy or patients likely to require prohibited concomitant therapy during participation in the study
- Patients with a pacemaker
- Concomitant disease of the central nervous system that would bias the study evaluations, e.g.
- stroke, brain tumor, Parkinson's disease, significant brain trauma, Alzheimer's disease, epilepsy, multiple sclerosis, currently-treated migraine
- A DSM-IV Axis I diagnosis other than schizophrenia or with a DSM-IV diagnosis of substance dependence within 6 months prior to screening evaluation (nicotine and caffeine dependence are not exclusionary)
- Diabetes mellitus and/or repeated fasting blood glucose value during the washout period >126 mg/dl and /or HbA1C > 7. 5%, hypothalamo-hypophyse dysfunction, Cushing, Addison, thyrotoxicosis, or Anemia (as defined by hematocrit < 30%)
- Suicidal or homicidal ideation
- Positive drug screen at screening and at baseline
Sites / Locations
Outcomes
Primary Outcome Measures
A non-inferiority comparison of the orthostatic tolerability of a higher initial dose of paliperidone OROS with the current recommended initial dose of risperidone in patients with schizophrenia
Secondary Outcome Measures
To compare the tolerability and safety of a clinically equivalent fixed dose of paliperidone OROS with the recommended dose of risperidone; early tolerability of the two formulations with placebo; tolerability using a pop PK/PD model
Full Information
NCT ID
NCT00791232
First Posted
November 13, 2008
Last Updated
June 6, 2011
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1. Study Identification
Unique Protocol Identification Number
NCT00791232
Brief Title
A Study of Extended Release Extended-release (ER) OROS Paliperidone Tolerability, as Compared to Immediate-release (IR)Risperidone, in Patients With Schizophrenia
Official Title
A Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Phase 1 Study to Compare the Tolerability of OROS Paliperidone (Extended Release) With Immediate-release (IR) Risperidone in Subjects With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is a noninferiority comparison of the orthostatic tolerability of a dose of 12 mg extended-release (ER) OROS paliperidone with the current recommended initial titration dose (2 mg) of immediate-release (IR) risperidone in patients with schizophrenia. Other study objectives are 1) to compare the tolerability and safety of a clinically equivalent fixed dose of ER OROS paliperidone with the currently recommended dose of risperidone, 2) to compare the early tolerability of the 2 treatments with placebo, 3) to compare tolerability of the 2 treatments, using a population pharmacokinetic/pharmacodynamic (pop PK/PD) model, to 4) assess the relationship between genetic variability in drug metabolizing enzymes and interindividual variability in plasma exposure to paliperidone or risperidone within each treatment group.
Detailed Description
This is a randomized, double-blind, placebo- and active-controlled, parallel group, Phase 1. The study in patients with schizophrenia consists of a 1 week, open-label, placebo washout period (Days -7 to -1) and a 6 day double-blind treatment period during which patients will receive 1 of 3 treatments: placebo on Day 1 and ER OROS paliperidone (12 mg) on Days 2 to 6, ER OROS paliperidone (12 mg) on Days 1 to 6, or IR risperidone 2 mg on Day 1 and 4 mg on Days 2 to 6. Safety and tolerability will be monitored throughout the study.. ER OROS paliperidone (12 mg, oral) on Days 2 to 6, ER OROS paliperidone (12 mg, oral) on Days 1 to 6, or IR risperidone (oral) 2 mg on Day 1 and 4 mg on Days 2 to 6
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Extended-release paliperidone, Schizophrenia, Mood disorders, Antipsychotic drugs, ER OROS paliperidone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
extended-release (ER) OROS paliperidone
Primary Outcome Measure Information:
Title
A non-inferiority comparison of the orthostatic tolerability of a higher initial dose of paliperidone OROS with the current recommended initial dose of risperidone in patients with schizophrenia
Secondary Outcome Measure Information:
Title
To compare the tolerability and safety of a clinically equivalent fixed dose of paliperidone OROS with the recommended dose of risperidone; early tolerability of the two formulations with placebo; tolerability using a pop PK/PD model
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Willingness to spend 2 weeks as an in-patient during the washout and treatment period
Currently treated with oral risperidone antipsychotic monotherapy for at least 1 month prior to screening
DSM-IV diagnosis of schizophrenia (Patients with a diagnosis of schizophrenia [paranoid type (295.30), disorganized type (295.10), catatonic type (295.20), undifferentiated type (295.90), or residual type (295.60)] as defined by DSM-IV criteria
Absence of acute exacerbation for a minimum of 6 months prior to screening
Female patients must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before screening and throughout the study, and have a negative urine pregnancy test at screening and baseline
The patient is otherwise healthy on the basis of a physical examination, medical history, electrocardiogram, and the results of blood biochemistry and hematology tests and a urinalysis performed within 30 days of the start of the treatment period. If the results of the biochemistry or hematology tests or the urinalysis testing are not within the laboratory's reference ranges, the patient may be included only on condition that the investigator judges that the deviations are not clinically significant.
Exclusion Criteria:
Involuntarily committed in-patients
Patients who have received long-acting depot antipsychotic medication (discontinued RISPERDAL CONSTA for less than 10 weeks or discontinued other depots for less than 2 cycles)
Any significant history of cardiovascular disease: atrial fibrillation or flutter, second and third degree heart block and equivalent, resting supraventricular tachycardia (>100 beats per minute), unstable atherosclerotic heart disease, valvular abnormality
Body Mass Index > = 35 kg/m2 or a history of or current hypertension
Use of disallowed concomitant therapy or patients likely to require prohibited concomitant therapy during participation in the study
Patients with a pacemaker
Concomitant disease of the central nervous system that would bias the study evaluations, e.g.
stroke, brain tumor, Parkinson's disease, significant brain trauma, Alzheimer's disease, epilepsy, multiple sclerosis, currently-treated migraine
A DSM-IV Axis I diagnosis other than schizophrenia or with a DSM-IV diagnosis of substance dependence within 6 months prior to screening evaluation (nicotine and caffeine dependence are not exclusionary)
Diabetes mellitus and/or repeated fasting blood glucose value during the washout period >126 mg/dl and /or HbA1C > 7. 5%, hypothalamo-hypophyse dysfunction, Cushing, Addison, thyrotoxicosis, or Anemia (as defined by hematocrit < 30%)
Suicidal or homicidal ideation
Positive drug screen at screening and at baseline
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=576&filename=CR004273_CSR.pdf
Description
A study of ER OROS paliperidone tolerability, as compared to IR risperidone, in patients with schizophrenia
Learn more about this trial
A Study of Extended Release Extended-release (ER) OROS Paliperidone Tolerability, as Compared to Immediate-release (IR)Risperidone, in Patients With Schizophrenia
We'll reach out to this number within 24 hrs