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
2 other identifiers
interventional
154
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2003
Shorter than P25 for phase_4
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 28, 2008
CompletedFirst Posted
Study publicly available on registry
April 1, 2008
CompletedDecember 5, 2018
December 1, 2018
March 28, 2008
December 3, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Total pain relief were calculated as the summed weighted pain releif scores
8 hours
Secondary Outcomes (6)
adverse events
approximately 5 days after treated cycle
laboratory analyses
screening
Subjects' global evaluation of the study drug
8 hours and 72 hours
Summed pain intensity difference
8 hours
Percent of subjects who took rescue medication
72 hours
- +1 more secondary outcomes
Study Arms (2)
Arm 1
ACTIVE COMPARATORArm 2
ACTIVE COMPARATORInterventions
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- Subjects who were pregnant, lactating, breastfeeding or not using adequate methods of birth control
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (10)
Pfizer Investigational Site
Salvador, Estado de Bahia, Brazil
Pfizer Investigational Site
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 28, 2008
First Posted
April 1, 2008
Study Start
January 1, 2003
Study Completion
July 1, 2003
Last Updated
December 5, 2018
Record last verified: 2018-12