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

Study Description

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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

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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

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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

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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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 History of Changes
Other Study ID Numbers:	VALA-0513-137; A3471081
First Posted:	April 1, 2008
Last Update Posted:	April 10, 2008
Last Verified:	March 2008

Additional relevant MeSH terms:

Dysmenorrhea; Menstruation Disturbances; Pathologic Processes; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; 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