Clinical trial NCT00649415: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dysmenorrhea
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 154
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Total pain relief were calculated as the summed weighted pain releif scores
timeFrame: 8 hours
Secondary outcomes:
measure: adverse events
timeFrame: approximately 5 days after treated cycle
measure: laboratory analyses
timeFrame: screening
measure: Subjects' global evaluation of the study drug
timeFrame: 8 hours and 72 hours
measure: Summed pain intensity difference
timeFrame: 8 hours
measure: Percent of subjects who took rescue medication
timeFrame: 72 hours
measure: Percent of subjects who took the second dose of study medication
timeFrame: 72 hours
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Pfizer Investigational Site
state: Bahia
city: Goiania
country: Brazil
facility: Pfizer Investigational Site
state: Goias
city: Belo Horizonte
country: Brazil
facility: Pfizer Investigational Site
state: Minas Gerais
city: Belo Horizonte
country: Brazil
facility: Pfizer Investigational Site
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: Rio Grande Do Sul
city: Rio De Janeiro
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: