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

This study has been completed.

First Received: March 28, 2008 Last Updated: April 7, 2008 History of Changes

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00649415

Purpose

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	Intervention	Phase
Dysmenorrhea	Drug: piroxicam Drug: valdecoxib	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Menstruation

Drug Information available for: Piroxicam Valdecoxib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Total pain relief were calculated as the summed weighted pain releif scores [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

adverse events [ Time Frame: approximately 5 days after treated cycle ] [ Designated as safety issue: Yes ]
laboratory analyses [ Time Frame: screening ] [ Designated as safety issue: Yes ]
Subjects' global evaluation of the study drug [ Time Frame: 8 hours and 72 hours ] [ Designated as safety issue: No ]
Summed pain intensity difference [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
Percent of subjects who took rescue medication [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Percent of subjects who took the second dose of study medication [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Enrollment:	154
Study Start Date:	January 2003
Study Completion Date:	July 2003

Arms	Assigned Interventions
Arm 1: Active Comparator	Drug: piroxicam piroxicam 40 mg capsule QD for up to the first 3 days of the menstrual cycle
Arm 2: Active Comparator	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

Eligibility

Ages Eligible for Study:	18 Years to 44 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00649415

Locations

Brazil, Bahia
Pfizer Investigational Site
Salvador, Bahia, Brazil
Brazil, Goias
Pfizer Investigational Site
Goiania, Goias, Brazil
Brazil, Minas Gerais
Pfizer Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30130-100
Pfizer Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30130-110
Brazil, Rio Grande do Sul
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Brazil, RJ
Pfizer Investigational Site
Rio De Janeiro, RJ, Brazil, 20551-030
Brazil, RS
Pfizer Investigational Site
Porto Alegre, RS, Brazil
Brazil, SP
Pfizer Investigational Site
São Paulo, SP, Brazil
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. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org posting: This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
ClinicalTrials.gov Identifier:	NCT00649415 History of Changes
Other Study ID Numbers:	VALA-0513-137, A3471081
Study First Received:	March 28, 2008
Last Updated:	April 7, 2008
Health Authority:	Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:

Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Signs and Symptoms
Piroxicam
Valdecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 02, 2010