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

Dysmenorrhea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00649415
• Other study ID #: VALA-0513-137
• Secondary ID: A3471081
• Status: Completed
• Phase: Phase 4
• Start date: January 2003
• Est. completion date: July 2003

Study information

• Verified date: December 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysmenorrhea

Intervention

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

Locations

Country	Name	City	State
Brazil	Pfizer Investigational Site	Belo Horizonte	Minas Gerais
Brazil	Pfizer Investigational Site	Belo Horizonte	Minas Gerais
Brazil	Pfizer Investigational Site	Goiania	Goias
Brazil	Pfizer Investigational Site	Porto Alegre	RS
Brazil	Pfizer Investigational Site	Porto Alegre	Rio Grande Do Sul
Brazil	Pfizer Investigational Site	Rio De Janeiro	RJ
Brazil	Pfizer Investigational Site	Salvador	Bahia
Brazil	Pfizer Investigational Site	Sao Paulo
Brazil	Pfizer Investigational Site	São Paulo
Brazil	Pfizer Investigational Site	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total pain relief were calculated as the summed weighted pain releif scores		8 hours
Secondary	adverse events		approximately 5 days after treated cycle
Secondary	laboratory analyses		screening
Secondary	Subjects' global evaluation of the study drug		8 hours and 72 hours
Secondary	Summed pain intensity difference		8 hours
Secondary	Percent of subjects who took rescue medication		72 hours
Secondary	Percent of subjects who took the second dose of study medication		72 hours

External Links

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