Celebrex In Acute Gouty Arthritis Study

Completed · Phase 3

Conditions studied: Arthritis, Gouty

In brief

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.

Key facts

Study ID

NCT00549549

Run by

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

People needed

402

Starts

2008-02-01

Expected to finish

2009-12-01

Last updated by the study team

2021-02-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Mesa, Arizona, United States
• Pfizer Investigational Site — Paradise Valley, Arizona, United States
• Pfizer Investigational Site — Peoria, Arizona, United States
• Pfizer Investigational Site — Roseville, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — San Luis Obispo, California, United States
• Pfizer Investigational Site — Longmont, Colorado, United States
• Pfizer Investigational Site — Northglenn, Colorado, United States
• Pfizer Investigational Site — DeLand, Florida, United States
• Pfizer Investigational Site — Gainesville, Florida, United States
• Pfizer Investigational Site — Tampa, Florida, United States
• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — Dunwoody, Georgia, United States
• Pfizer Investigational Site — Rockford, Illinois, United States
• Pfizer Investigational Site — Lexington, Kentucky, United States
• Pfizer Investigational Site — Mount Sterling, Kentucky, United States
• Pfizer Investigational Site — Shreveport, Louisiana, United States
• Pfizer Investigational Site — Shreveport, Louisiana, United States
• Pfizer Investigational Site — Wheaton, Maryland, United States
• Pfizer Investigational Site — Lansing, Michigan, United States
• Pfizer Investigational Site — Chaska, Minnesota, United States
• Pfizer Investigational Site — Columbia, Missouri, United States
• Pfizer Investigational Site — Columbus, Missouri, United States
• Pfizer Investigational Site — St Louis, Missouri, United States
• Pfizer Investigational Site — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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