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

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Drug: Celecoxib; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 380
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85051
      • Pfizer Investigational Site
    • Tucson, Arizona, United States, 85712
      • Pfizer Investigational Site
  • California
    • Long Beach, California, United States, 90806
      • Pfizer Investigational Site
    • Paramount, California, United States, 90723
      • Pfizer Investigational Site
    • Tustin, California, United States, 92780
      • Pfizer Investigational Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80904
      • Pfizer Investigational Site
    • Wheat Ridge, Colorado, United States, 80033
      • Pfizer Investigational Site
  • Florida
    • DeLand, Florida, United States, 32720
      • Pfizer Investigational Site
    • Naples, Florida, United States, 34102
      • Pfizer Investigational Site
    • Pembroke Pines, Florida, United States, 33024
      • Pfizer Investigational Site
    • Saint Petersburg, Florida, United States, 33710
      • Pfizer Investigational Site
  • Georgia
    • Woodstock, Georgia, United States, 30189
      • Pfizer Investigational Site
  • Kansas
    • Overland Park, Kansas, United States, 66215
      • Pfizer Investigational Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70119
      • Pfizer Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21239
      • Pfizer Investigational Site
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Pfizer Investigational Site
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Pfizer Investigational Site
  • Nevada
    • Reno, Nevada, United States, 89502
      • Pfizer Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Pfizer Investigational Site
  • Ohio
    • Mason, Ohio, United States, 45040
      • Pfizer Investigational Site
  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009
      • Pfizer Investigational Site
    • Camp Hill, Pennsylvania, United States, 17011
      • Pfizer Investigational Site
    • Jenkintown, Pennsylvania, United States, 19046
      • Pfizer Investigational Site
  • South Carolina
    • Greensboro, South Carolina, United States, 27401
      • Pfizer Investigational Site
  • Tennessee
    • Johnson City, Tennessee, United States, 37601
      • Pfizer Investigational Site
    • Murfreesboro, Tennessee, United States, 37130
      • Pfizer Investigational Site
    • Nashville, Tennessee, United States, 37203
      • Pfizer Investigational Site
  • Texas
    • Austin, Texas, United States, 78705
      • Pfizer Investigational Site
    • San Antonio, Texas, United States, 78217
      • Pfizer Investigational Site
  • Washington
    • Seattle, Washington, United States, 98133
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A	Drug: Celecoxib; 200 mg oral capsule once daily for 6 weeks
Placebo Comparator: B	Drug: Placebo; Matched oral placebo for 6 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index	Week 6
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
Vital signs	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: December 1, 2003
• Study Completion (Actual): September 1, 2004

Study Registration Dates

• First Submitted: March 17, 2008
• First Submitted That Met QC Criteria: March 20, 2008
• First Posted (Estimate): March 21, 2008

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 29, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib
• Other Study ID Numbers: A3191069