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Celebrex In Acute Gouty Arthritis Study

NCT ID: NCT00549549

Last Updated: 2021-02-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

402 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-12-31

Brief Summary

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This is a multicenter, double-blind, double-dummy, randomized, active-controlled study that will include an 8-day treatment period followed by a 1-week follow-up period in patients experiencing symptoms of an acute exacerbation of gouty arthritis.

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Detailed Description

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Conditions

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Arthritis, Gouty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Indomethacin

Intervention Type DRUG

indomethacin 50 mg three times a day (TID) for 8 days.

2

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg two times a day (BID) for 7 days.

3

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later (celecoxib 400/200 mg regimen) and continuing 200 mg two times a day (BID) for 7 days.

4

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

Celecoxib 50 mg two times a day (BID) for 8 days

Interventions

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Indomethacin

indomethacin 50 mg three times a day (TID) for 8 days.

Intervention Type DRUG

Celecoxib

An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg two times a day (BID) for 7 days.

Intervention Type DRUG

Celecoxib

An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later (celecoxib 400/200 mg regimen) and continuing 200 mg two times a day (BID) for 7 days.

Intervention Type DRUG

Celecoxib

Celecoxib 50 mg two times a day (BID) for 8 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Acute gouty arthritis meeting the American College of Rheumatology (ACR) criteria for acute arthritis of primary gout;
* Onset of pain from an acute gouty arthritis attack within 48 hours prior to Screening/Baseline (Visit 1);
* A rating of moderate, severe, or extreme (2, 3, or 4, respectively) on the Patient's assessment of pain intensity in the index joint (5-point scale:0-4) at Screening/Baseline.

Exclusion Criteria

* Diagnosis of any other type of arthritis including those types suspected of being infectious in origin in the index joint or presence of any acute trauma of the index joint. Patients with osteoarthritis will be included as long as it is mild or moderate (according to investigator's criteria) and it does not affect the index joint;
* Acute polyarticular gout involving greater than 4 joints or chronic gout.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Glendale, Arizona, United States

Site Status

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Mesa, Arizona, United States

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Paradise Valley, Arizona, United States

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Peoria, Arizona, United States

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Roseville, California, United States

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San Diego, California, United States

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San Luis Obispo, California, United States

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Longmont, Colorado, United States

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Northglenn, Colorado, United States

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DeLand, Florida, United States

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Gainesville, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Dunwoody, Georgia, United States

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Rockford, Illinois, United States

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Lexington, Kentucky, United States

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Mount Sterling, Kentucky, United States

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Shreveport, Louisiana, United States

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Shreveport, Louisiana, United States

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Wheaton, Maryland, United States

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Lansing, Michigan, United States

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Chaska, Minnesota, United States

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Columbia, Missouri, United States

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Columbus, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Mineola, New York, United States

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Statesville, North Carolina, United States

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Lyndhurst, Ohio, United States

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Willoughby Hills, Ohio, United States

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Duncansville, Pennsylvania, United States

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Havertown, Pennsylvania, United States

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Nashville, Tennessee, United States

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New Tazewell, Tennessee, United States

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Beaumont, Texas, United States

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Beaumont, Texas, United States

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Bryan, Texas, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Tyler, Texas, United States

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Richmond, Virginia, United States

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Milwaukee, Wisconsin, United States

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Langley, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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St. John's, Newfoundland and Labrador, Canada

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Corunna, Ontario, Canada

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Sarnia, Ontario, Canada

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Toronto, Ontario, Canada

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Windsor, Ontario, Canada

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Québec, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Barranquilla, Atlántico, Colombia

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Barranquilla, Atlántico, Colombia

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Bucaramanga, Santander Department, Colombia

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Cartago, , Costa Rica

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Heredia, , Costa Rica

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México, D.F., Mexico

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Guadalajara, Jalisco, Mexico

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Mexico City, Mexico City, Mexico

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Lipa City, Batangas, Philippines

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Las Piñas, , Philippines

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Manila, , Philippines

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Manila, , Philippines

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Manila, , Philippines

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Quezon City, , Philippines

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Moscow, , Russia

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Petrozavodsk, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Suwon, Kyeongki-do, South Korea

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Daegu, , South Korea

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Seville, , Spain

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Hualien City, , Taiwan

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Taichung, , Taiwan

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Taipei, , Taiwan

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Phayathai, Bangkok, Thailand

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Khon Kaen, , Thailand

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Countries

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United States Canada Colombia Costa Rica Mexico Peru Philippines Russia South Korea Spain Taiwan Thailand

References

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Fravel MA, Ernst ME. Management of gout in the older adult. Am J Geriatr Pharmacother. 2011 Oct;9(5):271-85. doi: 10.1016/j.amjopharm.2011.07.004. Epub 2011 Aug 17.

Reference Type DERIVED
PMID: 21849262 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3191219&StudyName=Celebrex%20In%20Acute%20Gouty%20Arthritis%20Study

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

Other Identifiers

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A3191219

Identifier Type: -

Identifier Source: org_study_id

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