NCT00549549

Celebrex In Acute Gouty Arthritis Study

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 402 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthritis, Gouty

Interventions

Type	Name	Description
DRUG	Indomethacin	indomethacin 50 mg three times a day (TID) for 8 days.
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.
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.
DRUG	Celecoxib	Celecoxib 50 mg two times a day (BID) for 8 days

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2007-10-26
• Last updated: 2021-02-21
• Results posted: 2011-02-24

Locations

81 sites across 12 countries: United States, Canada, Colombia, Costa Rica, Mexico, Peru, Philippines, Russia, South Korea, Spain, Taiwan, Thailand