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

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.

Condition or disease	Intervention/treatment	Phase
Dysmenorrhea	Drug: piroxicam; Drug: valdecoxib	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 154 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: January 2003
• Actual Study Completion Date: July 2003

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Arm 1	Drug: piroxicam; piroxicam 40 mg capsule QD for up to the first 3 days of the menstrual cycle
Active Comparator: Arm 2	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

Outcome Measures

Primary Outcome Measures :

1. Total pain relief were calculated as the summed weighted pain releif scores [ Time Frame: 8 hours ]

Secondary Outcome Measures :

1. adverse events [ Time Frame: approximately 5 days after treated cycle ]
2. laboratory analyses [ Time Frame: screening ]
3. Subjects' global evaluation of the study drug [ Time Frame: 8 hours and 72 hours ]
4. Summed pain intensity difference [ Time Frame: 8 hours ]
5. Percent of subjects who took rescue medication [ Time Frame: 72 hours ]
6. Percent of subjects who took the second dose of study medication [ Time Frame: 72 hours ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 44 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Brazil

Pfizer Investigational Site

Salvador, Bahia, Brazil

Pfizer Investigational Site

Goiania, Goias, Brazil

Pfizer Investigational Site

Belo Horizonte, Minas Gerais, Brazil, 30130-100

Pfizer Investigational Site

Belo Horizonte, Minas Gerais, Brazil, 30130-110

Pfizer Investigational Site

Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000

Pfizer Investigational Site

Rio De Janeiro, RJ, Brazil, 20551-030

Pfizer Investigational Site

Porto Alegre, RS, Brazil

Pfizer Investigational Site

São Paulo, SP, Brazil

Pfizer Investigational Site

Sao Paulo, Brazil

Pfizer Investigational Site

São Paulo, Brazil, 04062-003

Sponsors and Collaborators

Pfizer

Investigators

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

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• ClinicalTrials.gov Identifier: NCT00649415
• Other Study ID Numbers: VALA-0513-137; A3471081
• First Posted: April 1, 2008
• Last Update Posted: December 5, 2018
• Last Verified: December 2018

Additional relevant MeSH terms:

Dysmenorrhea; Menstruation Disturbances; Pathologic Processes; Pelvic Pain; Pain; Neurologic Manifestations; Valdecoxib; Piroxicam; Cyclooxygenase 2 Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents