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

A Study of the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) and Three Times Daily Ibuprofen vs. Placebo in the Treatment of Subjects With Osteoarthritis of the Knee

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00620867

Enrollment

393

Registered

2008-02-22

Start date

2002-10-31

Completion date

2003-03-31

Last updated

2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Brief summary

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

Interventions

DRUGIbuprofen

800 mg oral tablet three time daily with meals for 6 weeks

DRUGcelecoxib

200 mg oral capsule once daily with morning meal for 6 weeks

OTHERplacebo

matched placebo orally for 6 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026