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

Condition(s) targeted: Dysmenorrhea

Intervention: piroxicam (Drug); valdecoxib (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study

Primary outcome: Total pain relief were calculated as the summed weighted pain releif scores

Secondary outcome:

adverse events

laboratory analyses

Subjects' global evaluation of the study drug

Summed pain intensity difference

Percent of subjects who took rescue medication

Percent of subjects who took the second dose of study medication

Minimum age: 18 Years. Maximum age: 44 Years. Gender(s): Female.

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

Pfizer Investigational Site, Sao Paulo, Brazil

Pfizer Investigational Site, São Paulo 04062-003, Brazil

Pfizer Investigational Site, Salvador, Bahia, Brazil

Pfizer Investigational Site, Goiania, Goias, 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, RJ 20551-030, Brazil

Pfizer Investigational Site, Porto Alegre, RS, Brazil

Pfizer Investigational Site, Porto Alegre, Rio Grande do Sul 90610-000, Brazil

Pfizer Investigational Site, São Paulo, SP, Brazil

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org posting:

Starting date: January 2003
Ending date: July 2003
Last updated: April 7, 2008