At a glance
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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
In Brief
A Phase 3 clinical trial evaluating Indomethacin and Celecoxib for Arthritis, Gouty. Completed, enrolled 402 participants across 81 sites in 12 countries.
Detailed Summary
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 Details
Timeline
Interventions
indomethacin 50 mg three times a day (TID) for 8 days.
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.
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.
Celecoxib 50 mg two times a day (BID) for 8 days