Safety and Efficacy of Celecoxib Versus Placebo in the Treatment of Knee Osteoarthritis in Patients 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: NCT00638807
• Other study ID #: A3191082
• Status: Completed
• Phase: Phase 4
• Start date: December 2003
• Est. completion date: July 2004

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 388
• Est. completion date: July 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Celecoxib
200 mg oral capsule once daily with morning meal for 6 weeks

Other:
• Placebo
Matched oral placebo for 6 weeks

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Arlington	Virginia
United States	Pfizer Investigational Site	Binghamton	New York
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Bismarck	North Dakota
United States	Pfizer Investigational Site	Boise	Idaho
United States	Pfizer Investigational Site	Boise	Idaho
United States	Pfizer Investigational Site	Bozeman	Montana
United States	Pfizer Investigational Site	Brooklyn	New York
United States	Pfizer Investigational Site	Buena Park	California
United States	Pfizer Investigational Site	Cary	North Carolina
United States	Pfizer Investigational Site	Charleston	South Carolina
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Duncansville	Pennsylvania
United States	Pfizer Investigational Site	Eugene	Oregon
United States	Pfizer Investigational Site	Johnstown	Pennsylvania
United States	Pfizer Investigational Site	Longwood	Florida
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Morton Grove	Illinois
United States	Pfizer Investigational Site	New Tazewell	Tennessee
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Norfolk	Virginia
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Springfield	Missouri
United States	Pfizer Investigational Site	Trenton	New Jersey
United States	Pfizer Investigational Site	Warwick	Rhode Island
United States	Pfizer Investigational Site	Washington	District of Columbia
United States	Pfizer Investigational Site	Wheaton	Maryland
United States	Pfizer Investigational Site	Wichita	Kansas
United States	Pfizer Investigational Site	Wichita	Kansas
United States	Pfizer Investigational Site	Winston-Salem	North Carolina
United States	Pfizer Investigational Site	Zephyrhills	Florida

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	Patient's Assessment of Arthritis Pain, according to VAS		Week 2
Secondary	The Western Ontario and McMaster Universities Osteoarthritis Index		Week 6
Secondary	Patient's and Physician's Global Assessment of Arthritis		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	Serious adverse events		Up to 30 days after last dose

External Links

•   To obtain contact information for a study center near you, click here.