Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00163241
Status:
TERMINATED
Last Update Posted:
2021-03-03
First Post:
2005-09-09
Brief Title:
Effect Of Celecoxib On Hip Osteoarthritis OA Progression
Sponsor:
Pfizers Upjohn has merged with Mylan to form Viatris Inc
Organization:
Pfizer
Study Overview
Official Title:
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
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Please see detailed description for termination reason
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 hipSecondaryAssess 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 hipEvaluate 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 investigatorEvaluate the tolerability and safety of a continuous 24-month intake of celecoxib 200 mg QD versus placebo in subjects with OA of the hip
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 hipSecondaryAssess 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 hipEvaluate 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 investigatorEvaluate 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None