A Double Blind, Double Dummy, Randomized, Comparative Study Of The Efficacy And Safety Of Valdecoxib 40 Mg Twice Daily, As Needed 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
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ClinicalTrials.gov Identifier: NCT00649415 |
Recruitment Status :
Completed
First Posted : April 1, 2008
Last Update Posted : December 5, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dysmenorrhea | Drug: piroxicam Drug: valdecoxib | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 154 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | January 2003 |
Actual Study Completion Date : | July 2003 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Arm 1 |
Drug: piroxicam
piroxicam 40 mg capsule QD for up to the first 3 days of the menstrual cycle |
Active Comparator: Arm 2 |
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 |
- Total pain relief were calculated as the summed weighted pain releif scores [ Time Frame: 8 hours ]
- adverse events [ Time Frame: approximately 5 days after treated cycle ]
- laboratory analyses [ Time Frame: screening ]
- Subjects' global evaluation of the study drug [ Time Frame: 8 hours and 72 hours ]
- Summed pain intensity difference [ Time Frame: 8 hours ]
- Percent of subjects who took rescue medication [ Time Frame: 72 hours ]
- Percent of subjects who took the second dose of study medication [ Time Frame: 72 hours ]

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Ages Eligible for Study: | 18 Years to 44 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- History of primary dysmenorrhea with moderate to severe menstrual cramping pain for which the patient took analgesic medication for at least three of six previous menstrual cycles before enrollment
- Subjects were to have been in good health and were to have had a complete physical exam (including a pap smear and an endovaginal or pelvic ultrasound, unless the subject had had these examinations performed within 6 months prior to the Screening Visit and the results were normal) prior to inclusion
Exclusion Criteria:
- Subjects who were pregnant, lactating, breastfeeding or not using adequate methods of birth control

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00649415
Brazil | |
Pfizer Investigational Site | |
Salvador, Bahia, Brazil | |
Pfizer Investigational Site | |
Goiania, Goias, Brazil | |
Pfizer Investigational Site | |
Belo Horizonte, Minas Gerais, Brazil, 30130-100 | |
Pfizer Investigational Site | |
Belo Horizonte, Minas Gerais, Brazil, 30130-110 | |
Pfizer Investigational Site | |
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000 | |
Pfizer Investigational Site | |
Rio De Janeiro, RJ, Brazil, 20551-030 | |
Pfizer Investigational Site | |
Porto Alegre, RS, Brazil | |
Pfizer Investigational Site | |
São Paulo, SP, Brazil | |
Pfizer Investigational Site | |
Sao Paulo, Brazil | |
Pfizer Investigational Site | |
São Paulo, Brazil, 04062-003 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
ClinicalTrials.gov Identifier: | NCT00649415 |
Other Study ID Numbers: |
VALA-0513-137 A3471081 |
First Posted: | April 1, 2008 Key Record Dates |
Last Update Posted: | December 5, 2018 |
Last Verified: | December 2018 |
Dysmenorrhea Menstruation Disturbances Pathologic Processes Pelvic Pain Pain Neurologic Manifestations Valdecoxib Piroxicam Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents |