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Celebrex In Acute Gouty Arthritis Study | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT00549549•Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (81)

Pfizer Investigational Site

Glendale, Arizona, United States

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

Key Dates

Start Date

February 1, 2008

Primary Completion Date

December 1, 2009

Completion Date

December 1, 2009

Last Updated

February 21, 2021

Enrollment

402

ACTUAL participants

Conditions

Arthritis, Gouty

Interventions

Indomethacin

DRUG

Celecoxib

DRUG

Celecoxib

DRUG

Celecoxib

DRUG

The MAD Study of SSGJ-613 in Healthy Subjects

NCT05966701

Arthritis, Gouty

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 21, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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