Celebrex In Acute Gouty Arthritis Study

Viatris

Status and phase

Completed

Phase 3

Conditions

Arthritis, Gouty

Treatments

Drug: Celecoxib

Drug: Indomethacin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00549549

A3191219

Details and patient eligibility

About

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.

Enrollment

402 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.