Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (Europe)

Phase 4

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Drug: Ibuprofen; Drug: Placebo; Drug: Celecoxib

• Registration Number: NCT00630929
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Study Completion: 2004-02
• Study First Submitted: 2008-02-28
• Study First Submitted QC: 2008-02-28
• Study First Posted: 2008-03-07
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 388

Inclusion Criteria

Inclusion criteria:

• Aged >=40 years old
• Diagnosed with OA of the knee according to the American College of Rheumatology and OA in flare state at baseline visit
• Functional capacity class of I-III

Exclusion Criteria

Exclusion criteria:

• Inflammatory arthritis or gout or pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
• Acute joint trauma at index joint within the past 3 months with active symptoms
• Score of >=20 on PHQ-9 or score of >=1 on PHQ-9 item i
• Use of mobility assisting device for <6 weeks or use of walker

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Ibuprofen	-
C	Placebo	-
B	Celecoxib	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in patient's assessment of arthritis pain according to visual analogue scale	Week 6

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index	Week 6
The Pain Satisfaction Scale	Week 6
Measurement of upper gastrointestinal tolerability	Weeks 2 and 6
Change from baseline in American Pain Society Modified Brief Pain Inventory Short Form pain scores	Days 1-7
Change from baseline in patient's assessment of arthritis pain according to visual analogue scale	Week 2
Adverse events	Weeks 2 and 6
Vital signs	Weeks 2 and 6
Physical examination	Week 6
Change from baseline in patient and physician global assessments of arthritis	Weeks 2 and 6
The Patient Health Questionnaire (PHQ-9)	Week 6
Laboratory test results	Week 6

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Wigan, United Kingdom