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Celebrex In Acute Gouty Arthritis Study

NCT00549549 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2021-02-21

Study results available
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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

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

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States
  • Canada
  • Colombia
  • Costa Rica
  • Mexico
  • Peru
  • Philippines
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00549549 on ClinicalTrials.gov