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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

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Salvador, Bahia, Brazil
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Dysmenorrhea
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-44 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subjects who were pregnant, lactating, breastfeeding or not using adequate methods of
birth control

NCT00649415
Pfizer
Completed
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

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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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Dysmenorrhea
  • 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
  • Active Comparator: Arm 1
    Intervention: Drug: piroxicam
  • Active Comparator: Arm 2
    Intervention: Drug: valdecoxib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
154
July 2003
Not Provided

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
Sexes Eligible for Study: Female
18 Years to 44 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT00649415
VALA-0513-137
A3471081
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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