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

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

Tracking Information

• First Submitted Date: March 28, 2008
• First Posted Date: April 1, 2008
• Last Update Posted Date: December 5, 2018
• Study Start Date: January 2003
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: March 28, 2008): Total pain relief were calculated as the summed weighted pain releif scores [ Time Frame: 8 hours ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT00649415 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Dysmenorrhea

Intervention

• 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

• Active Comparator: Arm 1
  Intervention: Drug: piroxicam
• Active Comparator: Arm 2
  Intervention: Drug: valdecoxib

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 28, 2008): 154
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: July 2003
• Primary Completion Date: Not Provided

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 44 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT00649415
• Other Study ID Numbers: VALA-0513-137; A3471081
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: December 2018