Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: RISPERDAL CONSTA (Drug); Paliperidone palmitate (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Official(s) and/or principal investigator(s): Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Summary
The purpose of this study is to demonstrate the effectiveness of paliperidone palmitate in
patients with Schizophrenia.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in the Positive and Negative Syndrome Scale (PANSS) Total Score for Schizophrenia
Secondary outcome: The Change From Baseline for the CGI-S ScoreThe Change From Baseline in the PSP Score
Detailed description:
This is a randomized (patients assigned to treatment groups by chance), double-blind
(patient and study staff will not know the treatment assignment) study of paliperidone
palmitate compared with RISPERDAL CONSTA (Risperidone Long-Acting Intramuscular Injection)
in adult patients with schizophrenia. The total duration of the study will be approximately
14 weeks. For those patients without source documentation of tolerability to oral (by mouth)
risperidone or paliperidone Extended Release (ER) tablets, injectable RISPERDAL CONSTA or
paliperidone palmitate, or those patients who were not currently taking another
antipsychotic, a minimum of 4 days and a maximum of 6 days of oral paliperidone ER treatment
at a dosage of 6 mg/day will be administered for tolerability testing before the first
injection of double-blind (DB) study drug (paliperidone palmitate or RISPERDAL CONSTA).
During the DB period, study drug will be administered to patients as an intramuscular (i. m.)
injection. Paliperidone palmitate (PP) 150mg equivalent (eq) (and RISPERDAL CONSTA placebo)
at Baseline (BL) (Day 1), 100mg eq at Visit (V) 4 (Day 8), 50 or 100mg eq at V7 (Day 36),
and 50,100,or 150mg eq at V9 (Day 64) or RISPERDAL CONSTA (RC) 25mg at V4 and V6 (Day 22),
25 or 37. 5mg at V7, and 25, 37. 5, or 50mg at V9 will be given as i. m. injections. Patients
in the RC group will also take risperidone tablets (1-6 mg/day) at BL for 28 days and be
given an injection of PP placebo at BL, V1, V7, and V9.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Meet diagnostic criteria for schizophrenia according to Diagnostic and Statistical
Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria as specified by the
protocol for at least 1 year before screening
- Prior medical records, written documentation or verbal information obtained from
previous psychiatric providers obtained by the investigator must be consistent with
the diagnosis of schizophrenia
- A total PANSS score between 60 and 120, inclusive, at screening and baseline; Body
mass index (BMI) at the screening visit BMI at least 17 kg/m2
- Female patients 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 as specified by the protocol. Women of
childbearing potential must have a negative serum beta-human chorionic gonadotropin
(b hCG) pregnancy test result at screening.
Exclusion Criteria:
- Patient unable to provide 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, or other systemic disease
including history of neuroleptic malignant syndrome; History of any severe
pre-existing gastrointestinal narrowing or inability to swallow oral study drug whole
with the aid of water (applies to those patients requiring oral tolerability only)
- Significant risk of suicidal or violent behavior, as clinically assessed by the
investigator ; History of life-threatening allergic reaction to any drug; Known or
suspected hypersensitivity or intolerance to risperidone, paliperidone, 20%
Intralipid, or any of their excipients (e. g., soybean oil, egg yolks, phospholipids,
and glycerol)
- Have received an experimental drug or experimental biologic, or used an experimental
medical device within 6 months before screening; History of any active malignancy
within the previous 5 years, with the exception of basal cell carcinomas
- Women who are pregnant or breast-feeding or are planning to become pregnant uring the
study
Locations and Contacts
Linz, Austria
Salzburg, Austria
Wien, Austria
Plovdiv N/A, Bulgaria
Varna, Bulgaria
Brno 18, Czech Republic
Brno, Czech Republic
Dobrany N/A, Czech Republic
Kromeriz, Czech Republic
Kutna Hora, Czech Republic
Olomouc 9, Czech Republic
Praha 8, Czech Republic
Praha, Czech Republic
Pärnu N/A, Estonia
Tallinn, Estonia
Tartu N/A, Estonia
Bourges Cedex N/A, France
Dole Cedex, France
Romans Sur Isere Cedex, France
Achim, Germany
Berlin, Germany
Bielefeld, Germany
Bochum, Germany
Jena, Germany
Leipzig, Germany
Mannheim, Germany
München, Germany
Stralsund, Germany
Baja, Hungary
Budapest N/A, Hungary
Budapest, Hungary
Gyõr, Hungary
Kalocsa, Hungary
Nagykallo N/A, Hungary
Aurangabad, India
Bangalore, India
Chandigarh, India
Mangalore, India
Pune, India
Varanasi, India
Alytus, Lithuania
Kaunas, Lithuania
Klaipeda, Lithuania
Vilnius, Lithuania
Belchatow, Poland
Bytom Na, Poland
Chelmno, Poland
Gdynia Na, Poland
Katowice Woj Slaskie, Poland
Krakow Na, Poland
Lubliniec, Poland
Piekary Slaskie Na, Poland
Skorzewo Na, Poland
Warszawa Na, Poland
Moscow N/A, Russian Federation
Moscow Russia, Russian Federation
Nizny Novgorod, Russian Federation
Saratov N/A, Russian Federation
St Petersburg N/A, Russian Federation
St Petersburg, Russian Federation
St-Petersburg, Russian Federation
Yaroslavl, Russian Federation
Barcelona, Spain
Madrid, Spain
San Juan, Spain
Dnepropetrovsk, Ukraine
Donetsk, Ukraine
Kharkiv, Ukraine
Kiev, Ukraine
Kyiv, Ukraine
Odessa, Ukraine
Simferopol, Ukraine
Birmingham, Alabama, United States
Little Rock, Arkansas, United States
Cerritos, California, United States
Garden Grove, California, United States
Los Angeles, California, United States
Washington, District of Columbia, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Flowood, Mississippi, United States
Hollis, New York, United States
Willoughby, Ohio, United States
Oklahoma City, Oklahoma, United States
Desoto, Texas, United States
Houston, Texas, United States
Odessa, Texas, United States
Additional Information
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
Starting date: March 2007
Last updated: June 11, 2014
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