Efficacy and Safety of Celecoxib as Add-on Therapy to Risperidone Versus Risperidone Alone in Patients With Schizophrenia
NCT ID: NCT00639483
Last Updated: 2009-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
270 participants
INTERVENTIONAL
2003-03-31
2004-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
Celecoxib
200 mg oral capsules twice daily as add-on therapy to risperidone twice daily (range 2-8 mg/day) for 11 weeks
B
Placebo
Matched oral placebo as add-on to risperidone twice daily (range 2-8 mg/day) for 11 weeks
Interventions
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Celecoxib
200 mg oral capsules twice daily as add-on therapy to risperidone twice daily (range 2-8 mg/day) for 11 weeks
Placebo
Matched oral placebo as add-on to risperidone twice daily (range 2-8 mg/day) for 11 weeks
Eligibility Criteria
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Inclusion Criteria
* Total PANSS score of ?60 at screening
* History of schizophrenia of ?10 years (from onset of prodromal symptoms)
Exclusion Criteria
* Less than a full cycle has lapsed at time of screening following the last injection of a depot antipsychotic
* Currently taking celecoxib or other selective cyclo-oxygenase 2 inhibitors, or other antiinflammatory medication
18 Years
50 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
La Plata, Buenos Aires, Argentina
Pfizer Investigational Site
Lanús, Buenos Aires, Argentina
Pfizer Investigational Site
La Plata, Pcia. de Buenos Aires, Argentina
Pfizer Investigational Site
PR, Curitiba, Brazil
Pfizer Investigational Site
Salvador, Estado de Bahia, Brazil
Pfizer Investigational Site
Aparecida de Goiânia, Goiania, Brazil
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, Brazil
Pfizer Investigational Site
São Paulo, São Paulo, Brazil
Pfizer Investigational Site
Bonn, , Germany
Pfizer Investigational Site
München, , Germany
Pfizer Investigational Site
München, , Germany
Pfizer Investigational Site
Münster, , Germany
Pfizer Investigational Site
Mexico City, , Mexico
Pfizer Investigational Site
Mandaluyong, , Philippines
Pfizer Investigational Site
Pasig, , Philippines
Pfizer Investigational Site
Niao-Sung Hsiang, Kaohsiung, Taiwan
Pfizer Investigational Site
Taipei, , Taiwan
Countries
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Related Links
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Other Identifiers
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A3191105
Identifier Type: -
Identifier Source: secondary_id
COXXNT-6570-001
Identifier Type: -
Identifier Source: org_study_id
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