CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 875 enrolled
Drug / intervention
Celecoxib +1 moredrug
Likely dose
Celecoxib 200 mg dailyAI-extracted
Key inclusion· 2
  • Diagnosed osteoarthritis of the hip or knee per American College of Rheumatology guidelines
  • Requires NSAIDs to control osteoarthritis pain
Key exclusion· 3
  • Prior surgery on the index joint
  • History of rheumatoid arthritis or fibromyalgia syndrome
  • Active gastrointestinal or cardiovascular disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00139776
NCT00139776Phase 4Completed

Double-Blind Parallel-Group Randomized Study Of Efficacy And Safety Of "Continuous Use" Of Celecoxib Vs. The "Usual Use" Of Celecoxib In The Treatment Of Subjects With Chronic Osteoarthritis Of The Hip Or Knee Who Require an Anti-inflammatory Medication for Control Of Their Pain

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Aug 31, 2005·Updated Mar 29, 2021

In Brief

A Phase 4 clinical trial evaluating Celecoxib for Osteoarthritis, Knee and Osteoarthritis, Hip. Completed, enrolled 875 participants across 124 sites in 8 countries.

Detailed Summary

To determine whether "continuous use" of celecoxib over a 6-month period is more efficacious than "usual or intermittent use" in preventing spontaneous osteoarthritis flares of the knee and hip.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Brazil, Canada, Chile, Colombia, France, United Kingdom, United States
Collaborators--

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 31, 2005
Enrollment StartJul 1, 2005
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 20.8 years ago

Interventions

Celecoxibdrug

24 weeks of study treatment: 2 weeks open-label celecoxib 200 mg daily followed by 22 weeks of randomized double blind celecoxib 200 mg daily. Placebo used as flare medication when directed.

Celecoxibdrug

24 weeks of study treatment: 2 weeks open-label celecoxib 200 mg daily followed by 22 weeks of randomized double blind placebo daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.