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

Phase 4

Completed

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

• Registration Number: NCT00638807
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

To compare the efficacy and safety of celecoxib versus placebo for the treatment of knee osteoarthritis (OA) in patients who were unresponsive to prescription strength naproxen and ibuprofen or who could not tolerate prescription strength naproxen and ibuprofen

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Study Completion: 2004-07
• Study First Submitted: 2008-03-12
• Study First Submitted QC: 2008-03-12
• Study First Posted: 2008-03-19
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-29
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

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

Inclusion Criteria

Inclusion criteria:

• Diagnosed, active, and symptomatic OA of the knee in a flare state with a functional capacity class of I-III at baseline visit
• 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

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 the baseline visit
• Use of a 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
• Received corticosteroids or hyaluronic acid within certain timeframe before study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Placebo	-
A	Celecoxib	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Seattle, Washington, United States