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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00649415
• Collaborator: (none)
• Enrollment: 154
• Locations: 10
• Arms: 2
• Duration (Months): 5.9
• Patients Per Site: 15.4
• Patients Per Site Per Month: 2.6

Study Details

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
• 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: Jan 1, 2003
• Actual Study Completion Date: Jul 1, 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 [8 hours]

Secondary Outcome Measures

1. adverse events [approximately 5 days after treated cycle]

2. laboratory analyses [screening]

3. Subjects' global evaluation of the study drug [8 hours and 72 hours]

4. Summed pain intensity difference [8 hours]

5. Percent of subjects who took rescue medication [72 hours]

6. Percent of subjects who took the second dose of study medication [72 hours]

Eligibility Criteria

Criteria

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

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

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Salvador	Bahia	Brazil
2	Pfizer Investigational Site	Goiania	Goias	Brazil
3	Pfizer Investigational Site	Belo Horizonte	Minas Gerais	Brazil	30130-100
4	Pfizer Investigational Site	Belo Horizonte	Minas Gerais	Brazil	30130-110
5	Pfizer Investigational Site	Porto Alegre	Rio Grande Do Sul	Brazil	90610-000
6	Pfizer Investigational Site	Rio De Janeiro	RJ	Brazil	20551-030
7	Pfizer Investigational Site	Porto Alegre	RS	Brazil
8	Pfizer Investigational Site	São Paulo	SP	Brazil
9	Pfizer Investigational Site	Sao Paulo		Brazil
10	Pfizer Investigational Site	São Paulo		Brazil	04062-003

Sponsors and Collaborators

• Pfizer

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00649415
• Other Study ID Numbers: VALA-0513-137; A3471081
• First Posted: Apr 1, 2008
• Last Update Posted: Dec 5, 2018
• Last Verified: Dec 1, 2018

• Additional relevant MeSH terms: Dysmenorrhea; Valdecoxib; Piroxicam

Study Results

No Results Posted as of Dec 5, 2018