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| ID | Type | Description | Link |
|---|---|---|---|
| A3191105 |
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To assess the efficacy and safety of celecoxib as add-on therapy to risperidone versus risperidone alone in patients with schizophrenia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | 200 mg oral capsules twice daily as add-on therapy to risperidone twice daily (range 2-8 mg/day) for 11 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score | Week 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Reported Outcomes using Treatment Satisfaction Questionnaire for Medication | Week 4 and 11 | |
| Physical examination | Week 11 | |
| Laboratory exams |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | La Plata | Buenos Aires | (1900) | Argentina | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Placebo | Drug | Matched oral placebo as add-on to risperidone twice daily (range 2-8 mg/day) for 11 weeks |
|
| Weeks 1, 2, 4, 6, 8, 11 |
| Change from baseline in Global Improvement and Efficacy Index scores of Clinical Global Impressions scale of Psychosis | Weeks 4, 6, and 11 |
| Change from baseline in total PANSS score | Weeks 4 and 6 |
| Change from baseline in PANSS-derived Brief Psychiatric Rating Scale score | Weeks 4, 6, and 11 |
| Change from baseline in combined PANSS Negative plus General Psychopathology Subscale Score and the separate PANSS Psychopathology Subscale Scores | Weeks 4, 6, and 11 |
| Change from baseline in PANSS five-factor component scores | Weeks 4, 6, and 11 |
| Time to onset of clinically meaningful improvement in total PANSS score | Weeks 1, 2, 4, 6, 8, and 11 |
| Adverse events | Weeks 1, 2, 4, 6, 8, 11 |
| Lanus |
| Buenos Aires |
| 1824 |
| Argentina |
| Pfizer Investigational Site | La Plata | Pcia. de Buenos Aires | 1900 | Argentina |
| Pfizer Investigational Site | PR | Curitiba | 80520-000 | Brazil |
| Pfizer Investigational Site | Salvador | Estado de Bahia | 40325-090 | Brazil |
| Pfizer Investigational Site | Aparecida de Goiânia | Goiania | 74922-810 | Brazil |
| Pfizer Investigational Site | Rio de Janeiro | Rio de Janeiro | 21944-970 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | Brazil |
| Pfizer Investigational Site | Bonn | 53105 | Germany |
| Pfizer Investigational Site | München | 80336 | Germany |
| Pfizer Investigational Site | München | 81675 | Germany |
| Pfizer Investigational Site | Münster | Germany |
| Pfizer Investigational Site | Mexico City | CP-14370 | Mexico |
| Pfizer Investigational Site | Mandaluyong | 1550 | Philippines |
| Pfizer Investigational Site | Pasig | Philippines |
| Pfizer Investigational Site | Niao-Sung Hsiang | Kaohsiung | Taiwan |
| Pfizer Investigational Site | Taipei | Taiwan |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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