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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00649415 |
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.
Condition | Intervention | Phase |
---|---|---|
Dysmenorrhea |
Drug: piroxicam Drug: valdecoxib |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Double Blind, Double Dummy, Randomized, Comparative Study Of The Efficacy And Safety Of Valdecoxib 40 Mg BID, PRN In The First Menstrual Cycle Day And Then Once A Day, And Piroxicam 40 Mg Once A Day In The Treatment Of Patients With Primary Dysmenorrhea |
Enrollment: | 154 |
Study Start Date: | January 2003 |
Study Completion Date: | July 2003 |
Arms | Assigned Interventions |
---|---|
Arm 1: Active Comparator |
Drug: piroxicam
piroxicam 40 mg capsule QD for up to the first 3 days of the menstrual cycle
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Arm 2: Active Comparator |
Drug: valdecoxib
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
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Ages Eligible for Study: | 18 Years to 44 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Brazil | |
Pfizer Investigational Site | |
Sao Paulo, Brazil | |
Pfizer Investigational Site | |
São Paulo, Brazil, 04062-003 | |
Brazil, Bahia | |
Pfizer Investigational Site | |
Salvador, Bahia, Brazil | |
Brazil, Goias | |
Pfizer Investigational Site | |
Goiania, Goias, Brazil | |
Brazil, Minas Gerais | |
Pfizer Investigational Site | |
Belo Horizonte, Minas Gerais, Brazil, 30130-100 | |
Pfizer Investigational Site | |
Belo Horizonte, Minas Gerais, Brazil, 30130-110 | |
Brazil, Rio Grande do Sul | |
Pfizer Investigational Site | |
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000 | |
Brazil, RJ | |
Pfizer Investigational Site | |
Rio De Janeiro, RJ, Brazil, 20551-030 | |
Brazil, RS | |
Pfizer Investigational Site | |
Porto Alegre, RS, Brazil | |
Brazil, SP | |
Pfizer Investigational Site | |
São Paulo, SP, Brazil |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | VALA-0513-137, A3471081 |
Study First Received: | March 28, 2008 |
Last Updated: | April 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00649415 |
Health Authority: | Brazil: National Health Surveillance Agency |
Signs and Symptoms Pelvic Pain Menstruation Disturbances Dysmenorrhea |
Piroxicam Pain Valdecoxib |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Pharmacologic Actions Pathologic Processes Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |