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Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (United States)

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ibuprofen
celecoxib
placebo
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged >= 40 years old
  • Diagnosed with OA of the knee according to the American College of Rheumatology and OA in flare state at baseline visit
  • Functional capacity class of I-III

Exclusion Criteria:

  • Inflammatory arthritis or gout or pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
  • Acute joint trauma at index joint within the past 3 months with active symptoms
  • Score of >=20 on PHQ-9 or score of >=1 on PHQ-9 item i
  • Use of mobility assisting device for <6 weeks or use of walker

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Ibuprofen

Celecoxib

placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in patient's assessment of arthritis pain according to visual analogue scale (VAS)

Secondary Outcome Measures

Vital signs
Physical examination
Laboratory test results
Adverse events
Change from baseline in patient's and physician's global assessment of pain
Pain Satisfaction Scale
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index
Patient Health Questionnaire (PHQ-9)
Change from baseline in patient's assessment of arthritis pain according to VAS

Full Information

First Posted
February 12, 2008
Last Updated
February 18, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00620867
Brief Title
Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (United States)
Official Title
A Study of the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) and Three Times Daily Ibuprofen vs. Placebo in the Treatment of Subjects With Osteoarthritis of the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
March 2003 (Actual)
Study Completion Date
March 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
393 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ibuprofen
Arm Type
Experimental
Arm Title
Celecoxib
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
800 mg oral tablet three time daily with meals for 6 weeks
Intervention Type
Drug
Intervention Name(s)
celecoxib
Intervention Description
200 mg oral capsule once daily with morning meal for 6 weeks
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
matched placebo orally for 6 weeks
Primary Outcome Measure Information:
Title
Change from baseline in patient's assessment of arthritis pain according to visual analogue scale (VAS)
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Vital signs
Time Frame
Weeks 2 and 6
Title
Physical examination
Time Frame
Week 6
Title
Laboratory test results
Time Frame
Week 6
Title
Adverse events
Time Frame
Weeks 2 and 6
Title
Change from baseline in patient's and physician's global assessment of pain
Time Frame
Weeks 2 and 6
Title
Pain Satisfaction Scale
Time Frame
Days 1-7
Title
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index
Time Frame
Week 6
Title
Patient Health Questionnaire (PHQ-9)
Time Frame
Week 6
Title
Change from baseline in patient's assessment of arthritis pain according to VAS
Time Frame
Week 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged >= 40 years old Diagnosed with OA of the knee according to the American College of Rheumatology and OA in flare state at baseline visit Functional capacity class of I-III Exclusion Criteria: Inflammatory arthritis or gout or pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded) Acute joint trauma at index joint within the past 3 months with active symptoms Score of >=20 on PHQ-9 or score of >=1 on PHQ-9 item i Use of mobility assisting device for <6 weeks or use of walker
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85051
Country
United States
Facility Name
Pfizer Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Pfizer Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Pfizer Investigational Site
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Pfizer Investigational Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Pfizer Investigational Site
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Pfizer Investigational Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Pfizer Investigational Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Pfizer Investigational Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47712
Country
United States
Facility Name
Pfizer Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Pfizer Investigational Site
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08817
Country
United States
Facility Name
Pfizer Investigational Site
City
South Plainfield
State/Province
New Jersey
ZIP/Postal Code
07080
Country
United States
Facility Name
Pfizer Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Pfizer Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10022-1009
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Pfizer Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43124
Country
United States
Facility Name
Pfizer Investigational Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Pfizer Investigational Site
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16601
Country
United States
Facility Name
Pfizer Investigational Site
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Pfizer Investigational Site
City
Newtown
State/Province
Pennsylvania
ZIP/Postal Code
18940
Country
United States
Facility Name
Pfizer Investigational Site
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Pfizer Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Pfizer Investigational Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Pfizer Investigational Site
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Pfizer Investigational Site
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37601
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Pfizer Investigational Site
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Pfizer Investigational Site
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3191063&StudyName=Efficacy%20and%20Safety%20of%20Celecoxib%20versus%20Ibuprofen%20in%20the%20Treatment%20of%20Osteoarthritis%20of%20the%20Knee%20%28United%20States%29
Description
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Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (United States)

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