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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
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00649415
First received: March 28, 2008
Last updated: April 7, 2008
Last verified: March 2008
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Purpose
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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Total pain relief were calculated as the summed weighted pain releif scores [ Time Frame: 8 hours ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 154 |
| Study Start Date: | January 2003 |
| Study Completion Date: | July 2003 |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 44 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00649415
Please refer to this study by its ClinicalTrials.gov identifier: NCT00649415
Locations
| 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 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00649415 History of Changes |
| Other Study ID Numbers: |
VALA-0513-137 A3471081 |
| Study First Received: | March 28, 2008 |
| Last Updated: | April 7, 2008 |
Additional relevant MeSH terms:
|
Dysmenorrhea Menstruation Disturbances Pathologic Processes Pelvic Pain Pain Neurologic Manifestations Signs and Symptoms 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 |
ClinicalTrials.gov processed this record on June 22, 2017