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| ID | Type | Description | Link |
|---|---|---|---|
| A3471081 |
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To compare the analgesic efficacy, safety, and tolerability of valdecoxib versus piroxicam in subjects with moderate to severe menstrual cramping pain associated with primary dysmenorrhea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator |
| |
| Arm 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| piroxicam | Drug | piroxicam 40 mg capsule QD for up to the first 3 days of the menstrual cycle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total pain relief were calculated as the summed weighted pain releif scores | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | approximately 5 days after treated cycle | |
| laboratory analyses | screening | |
| Subjects' global evaluation of the study drug |
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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 | Salvador | Estado de Bahia | Brazil | |||
| 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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| valdecoxib |
| Drug |
valdecoxib 40 mg capsule twice a day (BID), taken as required, on the first day of treatment in the menstrual cycle followed by oral valdecoxib 40 mg once a day (QD) for up to the first 3 days of the menstural cycle |
|
| 8 hours and 72 hours |
| Summed pain intensity difference | 8 hours |
| Percent of subjects who took rescue medication | 72 hours |
| Percent of subjects who took the second dose of study medication | 72 hours |
| Goiânia |
| Goiás |
| Brazil |
| Pfizer Investigational Site | Belo Horizonte | Minas Gerais | 30130-100 | Brazil |
| Pfizer Investigational Site | Belo Horizonte | Minas Gerais | 30130-110 | Brazil |
| Pfizer Investigational Site | Rio de Janeiro | Rio de Janeiro | 20551-030 | Brazil |
| Pfizer Investigational Site | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Pfizer Investigational Site | Porto Alegre | Rio Grande do Sul | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | Brazil |
| Pfizer Investigational Site | São Paulo | 04062-003 | Brazil |
| Pfizer Investigational Site | São Paulo | Brazil |
| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D010894 | Piroxicam |
| C406224 | valdecoxib |
| ID | Term |
|---|---|
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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