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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

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ClinicalTrials.gov Identifier: NCT00649415
Recruitment Status : Completed
First Posted : April 1, 2008
Last Update Posted : December 5, 2018
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 28, 2008
First Posted Date  ICMJE April 1, 2008
Last Update Posted Date December 5, 2018
Study Start Date  ICMJE January 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2008)
Total pain relief were calculated as the summed weighted pain releif scores [ Time Frame: 8 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00649415 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2008)
  • adverse events [ Time Frame: approximately 5 days after treated cycle ]
  • laboratory analyses [ Time Frame: screening ]
  • Subjects' global evaluation of the study drug [ Time Frame: 8 hours and 72 hours ]
  • Summed pain intensity difference [ Time Frame: 8 hours ]
  • Percent of subjects who took rescue medication [ Time Frame: 72 hours ]
  • Percent of subjects who took the second dose of study medication [ Time Frame: 72 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dysmenorrhea
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Arm 1
    Intervention: Drug: piroxicam
  • Active Comparator: Arm 2
    Intervention: Drug: valdecoxib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2008)
154
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 44 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00649415
Other Study ID Numbers  ICMJE VALA-0513-137
A3471081
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP