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

Condition(s) targeted: Osteoarthritis, Knee

Intervention: Celecoxib (Drug); Ibuprofen (Drug); Placebo (Other)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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

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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in patient's assessment of arthritis pain according to visual analogue scale

Secondary outcome:

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

Change from baseline in patient and physician global assessments of arthritis

Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index

The Pain Satisfaction Scale

The Patient Health Questionnaire (PHQ-9)

Measurement of upper gastrointestinal tolerability

Adverse events

Laboratory test results

Vital signs

Physical examination

Change from baseline in American Pain Society Modified Brief Pain Inventory Short Form pain scores

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Pfizer Investigational Site, Berlin 12687, Germany

Pfizer Investigational Site, Berlin 10435, Germany

Pfizer Investigational Site, Stade 21680, Germany

Pfizer Investigational Site, SCHWERIN 19057, Germany

Pfizer Investigational Site, Berlin 10559, Germany

Pfizer Investigational Site, Ostseebad Damp 24351, Germany

Pfizer Investigational Site, WEENER 26826, Germany

Pfizer Investigational Site, TOSTEDT 21255, Germany

Pfizer Investigational Site, Bad Muender 31848, Germany

Pfizer Investigational Site, Berlin 13125, Germany

Pfizer Investigational Site, Beckum 59269, Germany

Pfizer Investigational Site, CADIZ 11009, Spain

Pfizer Investigational Site, SEVILLA 41014, Spain

Pfizer Investigational Site, GUADALAJARA 19002, Spain

Pfizer Investigational Site, BARCELONA 08036, Spain

Pfizer Investigational Site, VALENCIA 46009, Spain

Pfizer Investigational Site, MADRID 28046, Spain

Pfizer Investigational Site, MADRID 28040, Spain

Pfizer Investigational Site, Madrid 28035, Spain

Pfizer Investigational Site, BARCELONA 08029, Spain

Pfizer Investigational Site, OVIEDO 33006, Spain

Pfizer Investigational Site, HUDDERSFIELD HD3 3EA, United Kingdom

Pfizer Investigational Site, MANCHESTER M41 5SL, United Kingdom

Pfizer Investigational Site, NEWCASTLE UPON TYNE NE7 7DN, United Kingdom

Pfizer Investigational Site, London NW3 2PF, United Kingdom

Pfizer Investigational Site, London SE5 9RS, United Kingdom

Pfizer Investigational Site, Wigan WN6 9EW, United Kingdom

Pfizer Investigational Site, CHELMSLY WOOD, BIRMINGHAM B37 7TR, United Kingdom

Pfizer Investigational Site, Truro, Cornwall TR1 3LJ, United Kingdom

Pfizer Investigational Site, CHORLEY, LANCS PR7 1NY, United Kingdom

Pfizer Investigational Site, LIVERPOOL, LANCS L1 9AD, United Kingdom

Pfizer Investigational Site, Cannock, Mid Staffordshire WS11 2XY, United Kingdom

Pfizer Investigational Site, ADDLESTONE, SURREY KT15 2BH, United Kingdom

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

Starting date: January 2003
Ending date: February 2004
Last updated: February 28, 2008