Back to resultsA 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
Primary Purpose
Dysmenorrhea
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
piroxicam
valdecoxib
Sponsored by
About this trial
This is an interventional treatment trial for Dysmenorrhea
Eligibility 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
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Total pain relief were calculated as the summed weighted pain releif scores
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00649415
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
154 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Active Comparator
Arm Title
Arm 2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
piroxicam
Intervention Description
piroxicam 40 mg capsule QD for up to the first 3 days of the menstrual cycle
Intervention Type
Drug
Intervention Name(s)
valdecoxib
Intervention Description
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
Primary Outcome Measure Information:
Title
Total pain relief were calculated as the summed weighted pain releif scores
Time Frame
8 hours
Secondary Outcome Measure Information:
Title
adverse events
Time Frame
approximately 5 days after treated cycle
Title
laboratory analyses
Time Frame
screening
Title
Subjects' global evaluation of the study drug
Time Frame
8 hours and 72 hours
Title
Summed pain intensity difference
Time Frame
8 hours
Title
Percent of subjects who took rescue medication
Time Frame
72 hours
Title
Percent of subjects who took the second dose of study medication
Time Frame
72 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Salvador
State/Province
Bahia
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Goiania
State/Province
Goias
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-100
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-110
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Rio De Janeiro
State/Province
RJ
ZIP/Postal Code
20551-030
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
Pfizer Investigational Site
City
São Paulo
State/Province
SP
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Sao Paulo
Country
Brazil
Facility Name
Pfizer Investigational Site
City
São Paulo
ZIP/Postal Code
04062-003
Country
Brazil
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=VALA-0513-137
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
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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