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

February 18, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

388

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Muender, Germany, 31848
        • Pfizer Investigational Site
      • Beckum, Germany, 59269
        • Pfizer Investigational Site
      • Berlin, Germany, 12687
        • Pfizer Investigational Site
      • Berlin, Germany, 13125
        • Pfizer Investigational Site
      • Berlin, Germany, 10559
        • Pfizer Investigational Site
      • Berlin, Germany, 10435
        • Pfizer Investigational Site
      • Ostseebad Damp, Germany, 24351
        • Pfizer Investigational Site
      • Schwerin, Germany, 19057
        • Pfizer Investigational Site
      • Stade, Germany, 21680
        • Pfizer Investigational Site
      • Tostedt, Germany, 21255
        • Pfizer Investigational Site
      • Weener, Germany, 26826
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08036
        • Pfizer Investigational Site
      • Barcelona, Spain, 08029
        • Pfizer Investigational Site
      • Cadiz, Spain, 11009
        • Pfizer Investigational Site
      • Guadalajara, Spain, 19002
        • Pfizer Investigational Site
      • Madrid, Spain, 28040
        • Pfizer Investigational Site
      • Madrid, Spain, 28046
        • Pfizer Investigational Site
      • Madrid, Spain, 28035
        • Pfizer Investigational Site
      • Oviedo, Spain, 33006
        • Pfizer Investigational Site
      • Sevilla, Spain, 41014
        • Pfizer Investigational Site
      • Valencia, Spain, 46009
        • Pfizer Investigational Site
  • United Kingdom
      • Huddersfield, United Kingdom, HD3 3EA
        • Pfizer Investigational Site
      • London, United Kingdom, SE5 9RS
        • Pfizer Investigational Site
      • London, United Kingdom, NW3 2PF
        • Pfizer Investigational Site
      • Manchester, United Kingdom, M41 5SL
        • Pfizer Investigational Site
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • Pfizer Investigational Site
      • Wigan, United Kingdom, WN6 9EW
        • Pfizer Investigational Site
    • Birmingham
      • Chelmsly WOOD, Birmingham, United Kingdom, B37 7TR
        • Pfizer Investigational Site
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LJ
        • Pfizer Investigational Site
    • Lancs
      • Chorley, Lancs, United Kingdom, PR7 1NY
        • Pfizer Investigational Site
      • Liverpool, Lancs, United Kingdom, L1 9AD
        • Pfizer Investigational Site
    • Mid Staffordshire
      • Cannock, Mid Staffordshire, United Kingdom, WS11 2XY
        • Pfizer Investigational Site
    • Surrey
      • Addlestone, Surrey, United Kingdom, KT15 2BH
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Drug: Ibuprofen
800 mg oral tablet 3 times daily with meals for 6 weeks
Placebo Comparator: C
Drug: Placebo
Matched placebo orally for 6 weeks
Experimental: B
Drug: Celecoxib
200 mg oral capsule once daily with morning meal 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 analogue scale
Time Frame: Week 6
Week 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Physical examination
Time Frame: Week 6
Week 6
Vital signs
Time Frame: Weeks 2 and 6
Weeks 2 and 6
Laboratory test results
Time Frame: Week 6
Week 6
Adverse events
Time Frame: Weeks 2 and 6
Weeks 2 and 6
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index
Time Frame: Week 6
Week 6
Change from baseline in American Pain Society Modified Brief Pain Inventory Short Form pain scores
Time Frame: Days 1-7
Days 1-7
Change from baseline in patient's assessment of arthritis pain according to visual analogue scale
Time Frame: Week 2
Week 2
Change from baseline in patient and physician global assessments of arthritis
Time Frame: Weeks 2 and 6
Weeks 2 and 6
The Pain Satisfaction Scale
Time Frame: Week 6
Week 6
The Patient Health Questionnaire (PHQ-9)
Time Frame: Week 6
Week 6
Measurement of upper gastrointestinal tolerability
Time Frame: Weeks 2 and 6
Weeks 2 and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

February 28, 2008

First Submitted That Met QC Criteria

February 28, 2008

First Posted (Estimate)

March 7, 2008

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3191062

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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