Official Title: “A Phase 3, Randomized, Double-Blind, Multicenter, Active-Controlled Trial To Evaluate The Efficacy And Safety Of Celecoxib (Celebrex®) And Indomethacin In The Treatment Of Moderate To Severe Acute Gouty Arthritis”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary:

• The primary endpoint of the study will be the Change from Baseline to Day 2 (24-hour recall of pain experienced during Day 2 assessed on the morning of Day 3) in the Patient's Assessment of Pain Intensity in the index joint. Day 1,2,3 No

Secondary:

• Incidence of at least a 30% and 50% reduction from Baseline in the Patient's Assessment of Pain Intensity on Day 2 (24-hour recall of pain experienced during Day 2 assessed on the morning of Day 3) Days1,2,3 No
• Change from Baseline to in the Patient's Assessment of Pain Intensity (24-hour recall of pain experienced during prior day as assessed on the next morning for each day), and average change in this measure over Days 2-5 and Days 2-8 Days 3, 4, 5, 6, 7, and 8 No
• Incidence of withdrawal due to lack of efficacy on Day 1 and over Days 1-8 Days1-8 No
• Patient's Global Evaluation of Study Medication score on Day 8 and Day 14 Day8, Day14 No
• Physician's Assessment of the Index Joint on : change from Baseline to each post-baseline assessment for "tenderness" and "swelling", and incidence at each post-baseline assessment of "redness Day 5, Day 9 and at Day 14, the end of the study visit No
• and warmth" Day 5, Day 9 and at Day 14, the end of the study visit No
• Percent change from Baseline in the Patient's Assessment of Pain Intensity for the prior 24 hours to the average Pain Intensity on Days 2-5 and Days 2-8 Days2-8 No
• Change from Baseline in the Patient's Assessment of Pain Intensity at each of 2, 4, 8 and 12 hours post first dose of study medication on Day 1, and both prior to the first dose of study medication on Day 2 (~24 hours after initiating study Day2 No
• medication) and prior to the second dose of study medication on Day 2 (~32 hours after initiating study medication) Day2 No
• Time to withdrawal due to lack of efficacy over days 1-8 Days1-8 No
• Time weighted average change from Baseline in the Patient's Assessment of Pain Intensity over 8 (TWA-8), 12 (TWA-12) and 24 (TWA-24) hours post first dose of study medication on Day 1 Day1 No

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.

Lead Sponsor: Pfizer

Pfizer Investigational Site

Huntsville Alabama 35801 United States

Pfizer Investigational Site

Peoria Arizona 85381 United States

Pfizer Investigational Site

Glendale Arizona 85304 United States

Pfizer Investigational Site

Mesa Arizona 85202 United States

Pfizer Investigational Site

Paradise Valley Arizona 85253 United States

Pfizer Investigational Site

San Diego California 92103-6204 United States

Pfizer Investigational Site

San Luis Obispo California 93405 United States

Pfizer Investigational Site

Sacramento California 95825 United States

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Northglenn Colorado 80234 United States

Pfizer Investigational Site

Longmont Colorado 80501 United States

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Tampa Florida 33614 United States

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DeLand Florida 32720 United States

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Atlanta Georgia 30308 United States

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Conyers Georgia 30094 United States

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Dunwoody Georgia 30338 United States

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Idaho Falls Idaho 83401 United States

Pfizer Investigational Site

Elmhurst Illinois 60126-2966 United States

Pfizer Investigational Site

Rockford Illinois 61107 United States

Pfizer Investigational Site

Lexington Kentucky 40503 United States

Pfizer Investigational Site

Mt. Sterling Kentucky 40353 United States

Pfizer Investigational Site

Shreveport Louisiana 71105-5634 United States

Pfizer Investigational Site

Shreveport Louisiana 71106 United States

Pfizer Investigational Site

Lansing Michigan 48910-8595 United States

Pfizer Investigational Site

Chaska Minnesota 55318 United States

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Flowood Mississippi 39232 United States

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Tupelo Mississippi 38801 United States

Pfizer Investigational Site

Columbia Missouri 65203 United States

Pfizer Investigational Site

Columbus Missouri 65212 United States

Pfizer Investigational Site

Omaha Nebraska 68134 United States

Pfizer Investigational Site

Mineola New York 11501 United States

Pfizer Investigational Site

Statesville North Carolina 28625 United States

Pfizer Investigational Site

Lyndhurst Ohio 44124 United States

Pfizer Investigational Site

Euclid Ohio 44132 United States

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Westlake Ohio 44145 United States

Pfizer Investigational Site

Duncansville Pennsylvania 16635 United States

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West Reading Pennsylvania 19611-1124 United States

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Havertown Pennsylvania 19083 United States

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New Tazewell Tennessee 37825 United States

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Nashville Tennessee 37203-6500 United States

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San Antonio Texas 78217 United States

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Dallas Texas 75235 United States

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Bryan Texas 77802 United States

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San Antonio Texas 78224 United States

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Beaumont Texas 77701 United States

Pfizer Investigational Site

Beaumont Texas 77706 United States

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Richmond Virginia 23294 United States

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Quebec  G1W 4R4 Canada

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Winnipeg Manitoba R2V 4W3 Canada

Pfizer Investigational Site

St. John's Newfoundland and Labrador A1A 3R5 Canada

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Sarnia Ontario N7T 4X3 Canada

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Corunna Ontario N0N 1G0 Canada

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Windsor Ontario N8X 5A6 Canada

Pfizer Investigational Site

Guadalajara Jalisco 44100 Mexico

Pfizer Investigational Site

Chesterfield  S40 4TF United Kingdom

Pfizer Investigational Site

Blackpool Lancashire FY4 3AD United Kingdom

Pfizer Investigational Site

Blackpool Lancashire FY3 7EN United Kingdom

Pfizer Investigational Site

Bolton Lancs BL3 6LT United Kingdom

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Overall Contact: Pfizer CT.gov Call Center 1-800-718-1021 

Information obtained from ClinicalTrials.gov on July 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00549549

Study ID Number: A3191219

ClinicalTrials.gov Identifier: NCT00549549

Health Authority: United States: Food and Drug Administration

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