Efficacy and Safety of Celecoxib Versus Placebo in the Treatment of Patients With Osteoarthritis of the Knee Who Were Unresponsive to Naproxen and Ibuprofen

A Double-Blind, Placebo-Controlled Study of the Efficacy and Tolerability of Once Daily Celebrex® (Celecoxib) vs. Placebo in the Treatment of Subjects With Osteoarthritis of the Knee Non-Responsive to Naproxen and Ibuprofen

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00640627

Enrollment

380

Registered

2008-03-21

Start date

2003-12-31

Completion date

2004-09-30

Last updated

2021-02-02

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 safety and efficacy of celecoxib versus placebo in the treatment of patients with knee osteoarthritis who were unresponsive to treatment with prescription strength naproxen and ibuprofen or who could not tolerate prescription strength naproxen and ibuprofen

Interventions

DRUGCelecoxib

200 mg oral capsule once daily for 6 weeks

DRUGPlacebo

Matched oral placebo 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

* OA of the knee in flare state at baseline visit and functional capacity class of I-III * Failed adequate trials of both naproxen and ibuprofen (prescription strength) within the past 5 years due to lack of efficacy, tolerability or both; duration of prescription strength ibuprofen and naproxen must have been a minimum of 2 weeks for each drug at the respective recommended doses if failure was due to lack of efficacy, and for any duration if failure was due to lack of tolerability

Exclusion criteria

* Inflammatory arthritis or gout/pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded) * Received acetaminophen within 24 hours of baseline visit * Use of mobility assisting device for less than six weeks prior to study screening or use of a walker * History of gastrointestinal (GI) perforation, obstruction, or bleeding * Diagnosed or treated for GI ulcer within 60 days prior to first dose of study medication * Recieved corticosteroids or hyaluronic acid within certain timeframe before study

Design outcomes

Primary

Measure	Time frame
Change from baseline in Patient's Assessment of Arthritis Pain, according to visual analog scale (VAS)	Week 6

Secondary

Measure	Time frame
Patient's and Physician's Global Assessment of Pain	Weeks 2 and 6
The Medical Outcomes Study Sleep Scale	Week 6
Adverse events	Weeks 0-6
Laboratory tests	Week 6
Western Ontario and McMaster Universities Osteoarthritis Index	Week 6
Physical examination	Week 6
Patient's Assessment of Arthritis Pain according to VAS	Week 2
Serious adverse events	Up to 30 days after last dose
Vital signs	Week 6

Countries

United States

Outcome results

None listed

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