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NCT00640627 Clinical Trial

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

Osteoarthritis, Knee Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00640627
Other study ID # A3191069
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 2003
Est. completion date September 2004

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 380
Est. completion date September 2004
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Celecoxib
200 mg oral capsule once daily for 6 weeks
• Placebo
Matched oral placebo for 6 weeks

Locations
Country Name City State
United States Pfizer Investigational Site Albuquerque New Mexico
United States Pfizer Investigational Site Austin Texas
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Beaver Pennsylvania
United States Pfizer Investigational Site Camp Hill Pennsylvania
United States Pfizer Investigational Site Chesterfield Missouri
United States Pfizer Investigational Site Colorado Springs Colorado
United States Pfizer Investigational Site DeLand Florida
United States Pfizer Investigational Site Flowood Mississippi
United States Pfizer Investigational Site Greensboro South Carolina
United States Pfizer Investigational Site Jenkintown Pennsylvania
United States Pfizer Investigational Site Johnson City Tennessee
United States Pfizer Investigational Site Long Beach California
United States Pfizer Investigational Site Mason Ohio
United States Pfizer Investigational Site Murfreesboro Tennessee
United States Pfizer Investigational Site Naples Florida
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site New Orleans Louisiana
United States Pfizer Investigational Site Overland Park Kansas
United States Pfizer Investigational Site Paramount California
United States Pfizer Investigational Site Pembroke Pines Florida
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Reno Nevada
United States Pfizer Investigational Site Saint Petersburg Florida
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site Seattle Washington
United States Pfizer Investigational Site Tucson Arizona
United States Pfizer Investigational Site Tustin California
United States Pfizer Investigational Site Wheat Ridge Colorado
United States Pfizer Investigational Site Woodstock Georgia

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in Patient's Assessment of Arthritis Pain, according to visual analog scale (VAS) Week 6
Secondary Western Ontario and McMaster Universities Osteoarthritis Index Week 6
Secondary Patient's and Physician's Global Assessment of Pain Weeks 2 and 6
Secondary The Medical Outcomes Study Sleep Scale Week 6
Secondary Adverse events Weeks 0-6
Secondary Laboratory tests Week 6
Secondary Vital signs Week 6
Secondary Physical examination Week 6
Secondary Patient's Assessment of Arthritis Pain according to VAS Week 2
Secondary Serious adverse events Up to 30 days after last dose
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