Osteoarthritis, Knee Clinical Trial
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
| NCT number | NCT00630929 |
| Other study ID # | A3191062 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | January 2003 |
| Est. completion date | February 2004 |
| Verified date | February 2021 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee.
| Status | Completed |
| Enrollment | 388 |
| Est. completion date | February 2004 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Pfizer Investigational Site | Bad Muender | |
| Germany | Pfizer Investigational Site | Beckum | |
| Germany | Pfizer Investigational Site | Berlin | |
| Germany | Pfizer Investigational Site | Berlin | |
| Germany | Pfizer Investigational Site | Berlin | |
| Germany | Pfizer Investigational Site | Berlin | |
| Germany | Pfizer Investigational Site | Ostseebad Damp | |
| Germany | Pfizer Investigational Site | Schwerin | |
| Germany | Pfizer Investigational Site | Stade | |
| Germany | Pfizer Investigational Site | Tostedt | |
| Germany | Pfizer Investigational Site | Weener | |
| Spain | Pfizer Investigational Site | Barcelona | |
| Spain | Pfizer Investigational Site | Barcelona | |
| Spain | Pfizer Investigational Site | Cadiz | |
| Spain | Pfizer Investigational Site | Guadalajara | |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Oviedo | |
| Spain | Pfizer Investigational Site | Sevilla | |
| Spain | Pfizer Investigational Site | Valencia | |
| United Kingdom | Pfizer Investigational Site | Addlestone | Surrey |
| United Kingdom | Pfizer Investigational Site | Cannock | Mid Staffordshire |
| United Kingdom | Pfizer Investigational Site | Chelmsly WOOD | Birmingham |
| United Kingdom | Pfizer Investigational Site | Chorley | Lancs |
| United Kingdom | Pfizer Investigational Site | Huddersfield | |
| United Kingdom | Pfizer Investigational Site | Liverpool | Lancs |
| United Kingdom | Pfizer Investigational Site | London | |
| United Kingdom | Pfizer Investigational Site | London | |
| United Kingdom | Pfizer Investigational Site | Manchester | |
| United Kingdom | Pfizer Investigational Site | Newcastle Upon Tyne | |
| United Kingdom | Pfizer Investigational Site | Truro | Cornwall |
| United Kingdom | Pfizer Investigational Site | Wigan |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
Germany, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in patient's assessment of arthritis pain according to visual analogue scale | Week 6 | ||
| Secondary | Change from baseline in American Pain Society Modified Brief Pain Inventory Short Form pain scores | Days 1-7 | ||
| Secondary | Change from baseline in patient's assessment of arthritis pain according to visual analogue scale | Week 2 | ||
| Secondary | Change from baseline in patient and physician global assessments of arthritis | Weeks 2 and 6 | ||
| Secondary | Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index | Week 6 | ||
| Secondary | The Pain Satisfaction Scale | Week 6 | ||
| Secondary | The Patient Health Questionnaire (PHQ-9) | Week 6 | ||
| Secondary | Measurement of upper gastrointestinal tolerability | Weeks 2 and 6 | ||
| Secondary | Adverse events | Weeks 2 and 6 | ||
| Secondary | Laboratory test results | Week 6 | ||
| Secondary | Vital signs | Weeks 2 and 6 | ||
| Secondary | Physical examination | Week 6 |
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