NCT00163241

Effect Of Celecoxib On Hip Osteoarthritis (OA) Progression

A Double-Blind, Placebo-Controlled, Randomized 24-Month Study, Assessing The Effect Of Celecoxib (Celebrex) Long Term Treatment On Hip Osteoarthritis (OA) Progression OSCARE

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 666 (planned)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Objectives of the study: Primary: Assess the ability of a continuous treatment of celecoxib 200 mg versus placebo administered once daily (QD) for 24 months in slowing disease progression as assessed radiographically in subjects with osteoarthritis (OA) of the hipSecondary:Assess the ability of a continuous treatment of celecoxib 200 mg versus placebo administered QD for 24 months in treating disease signs and symptoms in subjects with OA of the hip.Evaluate the ability of a continuous 24-month intake of celecoxib 200 mg QD versus placebo to reduce number of subjects eligible for hip replacement according to the investigator.Evaluate the tolerability and safety of a continuous 24-month intake of celecoxib 200 mg QD versus placebo in subjects with OA of the hip.

Detailed description

The study was terminated on 19 January 2006, prematurely, as a result of low enrollment Safety concerns did not lead to the decision to terminate this study.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	celecoxib

Timeline

• Start date: 2004-06-01
• Completion: 2006-01-01
• First posted: 2005-09-13
• Last updated: 2021-03-03

Locations

130 sites across 2 countries: Canada, France