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

Phase 4

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Other: placebo; Drug: celecoxib; Drug: Ibuprofen

• Registration Number: NCT00620867
• 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: 2002-10
• Primary Completion: 2003-03
• Study Completion: 2003-03
• Study First Submitted: 2008-02-12
• Study First Submitted QC: 2008-02-12
• Study First Posted: 2008-02-22
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 393

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

• 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
placebo	placebo	-
Celecoxib	celecoxib	-
Ibuprofen	Ibuprofen	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change from baseline in patient's and physician's global assessment of pain	Weeks 2 and 6
Pain Satisfaction Scale	Days 1-7
Physical examination	Week 6
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index	Week 6
Change from baseline in patient's assessment of arthritis pain according to VAS	Week 2
Vital signs	Weeks 2 and 6
Adverse events	Weeks 2 and 6
Patient Health Questionnaire (PHQ-9)	Week 6
Laboratory test results	Week 6

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Danville, Virginia, United States