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”

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.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: piroxicam
  • piroxicam 40 mg capsule QD for up to the first 3 days of the menstrual cycle
• 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Arm 1
• Active Comparator: Arm 2

Primary Measures

• Total pain relief were calculated as the summed weighted pain releif scores
  • Time Frame: 8 hours
    Safety Issue?: No

Secondary Measures

• adverse events
  • Time Frame: approximately 5 days after treated cycle
    Safety Issue?: Yes
• laboratory analyses
  • Time Frame: screening
    Safety Issue?: Yes
• Subjects' global evaluation of the study drug
  • Time Frame: 8 hours and 72 hours
    Safety Issue?: No
• Summed pain intensity difference
  • Time Frame: 8 hours
    Safety Issue?: No
• Percent of subjects who took rescue medication
  • Time Frame: 72 hours
    Safety Issue?: No
• Percent of subjects who took the second dose of study medication
  • Time Frame: 72 hours
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 44 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00649415

Study ID Number: VALA-0513-137

ClinicalTrials.gov Identifier: NCT00649415

Health Authority: Brazil: National Health Surveillance Agency

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