An Efficacy and Safety Study of Paliperidone Extended-Release (ER) Tablets in Participants With Schizophrenia
NCT ID: NCT00566631
Last Updated: 2013-08-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
294 participants
INTERVENTIONAL
2007-07-31
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Paliperidone Extended Release (ER)
Paliperidone
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion will be given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
Interventions
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Paliperidone
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion will be given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must be experiencing an acute schizophrenic episode with a Positive and Negative Syndrome Scale (PANSS) total score of greater than or equal to 70 at Baseline
* Must be admitted to hospital for treatment of the acute schizophrenic episode and must agree for voluntary hospitalization for at least the first 7 days of the study
* Female participants must be postmenopausal (for at least 1 year), surgically sterile, abstinent, or, if sexually active, be practicing and effective method of birth control (example, prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study and female participants of child-bearing potential must have a negative urine pregnancy test at Screening
* Participants or their legally acceptable representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Exclusion Criteria
* First antipsychotic treatment ever
* Have received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment and on clozapine or a long-acting injectable antipsychotic during the last 3 months
* Known hypersensitivity to paliperidone extended-release (ER) or risperidone
* Relevant history of any significant or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine, or immunologic diseases, history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome including recent or present clinically relevant laboratory abnormalities (as deemed by the Investigator) and participants with current or known history (over the past 6 months) of substance dependence according to DSM-IV Criteria
18 Years
ALL
No
Sponsors
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Janssen-Cilag International NV
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen-Cilag International NV, Belgium Clinical Trial
Role: STUDY_DIRECTOR
Janssen-Cilag International NV
Locations
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Zagreb, , Croatia
Dieppe, , France
La Charité-sur-Loire, , France
Metz, , France
Augsburg, , Germany
Bonn, , Germany
Mainz, , Germany
Mannheim, , Germany
München, , Germany
Rostock, , Germany
Wasserburg, , Germany
Be-Er Ya-Acov, , Israel
Beersheba, , Israel
Hod HaSharon, , Israel
Pardesiyya, , Israel
Ramat Gan, , Israel
Klaipėda, , Lithuania
Šiauliai, , Lithuania
Vilnius, , Lithuania
Gda Sk Poland, , Poland
Gmina Świecie, , Poland
Lodz, , Poland
Lublin, , Poland
Lubliniec, , Poland
Skąpe, , Poland
Torun, , Poland
Ząbki, , Poland
Bucharest, , Romania
Cluj-Napoca, , Romania
Craiova, , Romania
Countries
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Related Links
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Tolerability, Safety and Treatment Response of Flexible Doses of Paliperidone ER in Acutely Exacerbated Subjects With Schizophrenia
Other Identifiers
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R076477SCH3018
Identifier Type: -
Identifier Source: secondary_id
CR013162
Identifier Type: -
Identifier Source: org_study_id