Celebrex In Acute Gouty Arthritis Study

Condition(s) targeted: Arthritis, Gouty

Intervention: Indomethacin (Drug); Celecoxib (Drug); Celecoxib (Drug); Celecoxib (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

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

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

Primary outcome: 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.

Secondary outcome:

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

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)

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

Incidence of withdrawal due to lack of efficacy on Day 1 and over Days 1-8

Patient's Global Evaluation of Study Medication score on Day 8 and Day 14

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

and warmth"

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

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

medication) and prior to the second dose of study medication on Day 2 (~32 hours after initiating study medication)

Time to withdrawal due to lack of efficacy over days 1-8

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Quebec G1W 4R4, Canada; Recruiting

Pfizer Investigational Site, Cartago, Costa Rica; Recruiting

Pfizer Investigational Site, Heredia, Costa Rica; Recruiting

Pfizer Investigational Site, San Jose 0000, Costa Rica; Not yet recruiting

Pfizer Investigational Site, Milano 20162, Italy; Not yet recruiting

Pfizer Investigational Site, Roma 00144, Italy; Not yet recruiting

Pfizer Investigational Site, Daegu 705-718, Korea, Republic of; Recruiting

Pfizer Investigational Site, Lima 11, Peru; Recruiting

Pfizer Investigational Site, Lima L27, Peru; Recruiting

Pfizer Investigational Site, Lima 34, Peru; Recruiting

Pfizer Investigational Site, Quezon City 1102, Philippines; Recruiting

Pfizer Investigational Site, Manila 1008, Philippines; Recruiting

Pfizer Investigational Site, Las Piñas City 1742, Philippines; Recruiting

Pfizer Investigational Site, Manila 1000, Philippines; Recruiting

Pfizer Investigational Site, Manila 1003, Philippines; Recruiting

Pfizer Investigational Site, Moscow 115522, Russian Federation; Recruiting

Pfizer Investigational Site, St. Petersburg 193015, Russian Federation; Recruiting

Pfizer Investigational Site, St. Petersburg 194291, Russian Federation; Recruiting

Pfizer Investigational Site, Petrozavodsk 185019, Russian Federation; Recruiting

Pfizer Investigational Site, SEVILLA 41014, Spain; Terminated

Pfizer Investigational Site, Hualien 970, Taiwan; Recruiting

Pfizer Investigational Site, Taipei 106, Taiwan; Recruiting

Pfizer Investigational Site, Taichung 404, Taiwan; Recruiting

Pfizer Investigational Site, Khon Kaen 40002, Thailand; Recruiting

Pfizer Investigational Site, Peoria, Arizona 85381, United States; Recruiting

Pfizer Investigational Site, Glendale, Arizona 85304, United States; Recruiting

Pfizer Investigational Site, Mesa, Arizona 85202, United States; Recruiting

Pfizer Investigational Site, Paradise Valley, Arizona 85253, United States; Recruiting

Pfizer Investigational Site, Peoria, Arizona 85381, United States; Not yet recruiting

Pfizer Investigational Site, Barranquilla, Atlantico, Colombia; Recruiting

Pfizer Investigational Site, Barranquilla, Atlantico 0000, Colombia; Recruiting

Pfizer Investigational Site, Phayathai, Bangkok 10400, Thailand; Recruiting

Pfizer Investigational Site, Lipa City, Batangas 4217, Philippines; Recruiting

Pfizer Investigational Site, Langley, British Columbia V3A 4H9, Canada; Recruiting

Pfizer Investigational Site, San Diego, California 92103-6204, United States; Recruiting

Pfizer Investigational Site, San Luis Obispo, California 93405, United States; Recruiting

Pfizer Investigational Site, Roseville, California 95661, United States; Recruiting

Pfizer Investigational Site, Carmichael, California 95608, United States; Not yet recruiting

Pfizer Investigational Site, Sacramento, California 95825, United States; Not yet recruiting

Pfizer Investigational Site, Chonju, Chonbuk 561-712, Korea, Republic of; Recruiting

Pfizer Investigational Site, Northglenn, Colorado 80234, United States; Recruiting

Pfizer Investigational Site, Longmont, Colorado 80501, United States; Recruiting

Pfizer Investigational Site, Bogota, Cundinamarca, Colombia; Recruiting

Pfizer Investigational Site, Mexico, D.F. 06726, Mexico; Recruiting

Pfizer Investigational Site, Mexico, DF 06700, Mexico; Recruiting

Pfizer Investigational Site, Mexico, DF 10700, Mexico; Not yet recruiting

Pfizer Investigational Site, Gainesville, Florida 32607, United States; Recruiting

Pfizer Investigational Site, DeLand, Florida 32720, United States; Recruiting

Pfizer Investigational Site, Tampa, Florida 33606, United States; Recruiting

Pfizer Investigational Site, Atlanta, Georgia 30342, United States; Recruiting

Pfizer Investigational Site, Dunwoody, Georgia 30338, United States; Recruiting

Pfizer Investigational Site, Rockford, Illinois 61107, United States; Recruiting

Pfizer Investigational Site, Guadalajara, Jalisco 44100, Mexico; Recruiting

Pfizer Investigational Site, Lexington, Kentucky 40503, United States; Recruiting

Pfizer Investigational Site, Mt. Sterling, Kentucky 40353, United States; Recruiting

Pfizer Investigational Site, Suwon-si, Kyeongki-do 443-721, Korea, Republic of; Recruiting

Pfizer Investigational Site, Shreveport, Louisiana 71105-5634, United States; Recruiting

Pfizer Investigational Site, Shreveport, Louisiana 71106, United States; Recruiting

Pfizer Investigational Site, Winnipeg, Manitoba R2V 4W3, Canada; Recruiting

Pfizer Investigational Site, Wheaton, Maryland 20902, United States; Recruiting

Pfizer Investigational Site, Lansing, Michigan 48910-8595, United States; Recruiting

Pfizer Investigational Site, Chaska, Minnesota 55318, United States; Recruiting

Pfizer Investigational Site, St. Louis, Missouri 63141, United States; Recruiting

Pfizer Investigational Site, Columbia, Missouri 65203, United States; Recruiting

Pfizer Investigational Site, Columbus, Missouri 65212, United States; Recruiting

Pfizer Investigational Site, Omaha, Nebraska 68134, United States; Recruiting

Pfizer Investigational Site, Mineola, New York 11501, United States; Recruiting

Pfizer Investigational Site, St. John's, Newfoundland and Labrador A1A 3R5, Canada; Recruiting

Pfizer Investigational Site, Mount Pearl, Newfoundland and Labrador A1N 1W7, Canada; Not yet recruiting

Pfizer Investigational Site, Statesville, North Carolina 28625, United States; Recruiting

Pfizer Investigational Site, Lyndhurst, Ohio 44124, United States; Terminated

Pfizer Investigational Site, Willoughby Hills, Ohio 44094, United States; Terminated

Pfizer Investigational Site, Sarnia, Ontario N7T 4X3, Canada; Recruiting

Pfizer Investigational Site, Corunna, Ontario N0N 1G0, Canada; Completed

Pfizer Investigational Site, Windsor, Ontario N8X 5A6, Canada; Recruiting

Pfizer Investigational Site, Toronto, Ontario M3M 3E5, Canada; Recruiting

Pfizer Investigational Site, Angeles City, Pampanga, Philippines; Not yet recruiting

Pfizer Investigational Site, Duncansville, Pennsylvania 16635, United States; Completed

Pfizer Investigational Site, Havertown, Pennsylvania 19083, United States; Recruiting

Pfizer Investigational Site, Bucaramanga, Santander, Colombia; Recruiting

Pfizer Investigational Site, Saskatoon, Saskatchewan S7K 7H9, Canada; Recruiting

Pfizer Investigational Site, New Tazewell, Tennessee 37825, United States; Recruiting

Pfizer Investigational Site, Nashville, Tennessee 37203, United States; Terminated

Pfizer Investigational Site, San Antonio, Texas 78217, United States; Recruiting

Pfizer Investigational Site, Dallas, Texas 75235, United States; Recruiting

Pfizer Investigational Site, Bryan, Texas 77802, United States; Completed

Pfizer Investigational Site, San Antonio, Texas 78224, United States; Completed

Pfizer Investigational Site, Beaumont, Texas 77701, United States; Terminated

Pfizer Investigational Site, Beaumont, Texas 77706, United States; Terminated

Pfizer Investigational Site, Tyler, Texas 75701, United States; Not yet recruiting

Pfizer Investigational Site, Richmond, Virginia 23294, United States; Recruiting

Pfizer Investigational Site, Milwaukee, Wisconsin 53295, United States; Recruiting

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

Starting date: February 2008
Ending date: December 2009
Last updated: October 9, 2009