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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date December 2018
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
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
Est. primary completion date
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

Study Design


Related Conditions & MeSH terms


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
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