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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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:
MedlinePlus related topics:
Menstruation
Drug Information available for:
Valdecoxib
U.S. FDA Resources
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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- adverse events [ Time Frame: approximately 5 days after treated cycle ] [ Designated as safety issue: Yes ]
- laboratory analyses [ Time Frame: screening ] [ Designated as safety issue: Yes ]
- Subjects' global evaluation of the study drug [ Time Frame: 8 hours and 72 hours ] [ Designated as safety issue: No ]
- Summed pain intensity difference [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
- Percent of subjects who took rescue medication [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
- Percent of subjects who took the second dose of study medication [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
| 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) |
| Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Additional relevant MeSH terms:
|
Dysmenorrhea Menstruation Disturbances Pathologic Processes Pelvic Pain Pain Neurologic Manifestations Signs and Symptoms Piroxicam Valdecoxib 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 Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cyclooxygenase 2 Inhibitors |
ClinicalTrials.gov processed this record on September 26, 2016