Osteoarthritis, Hip Clinical Trial
Official title:
Clinical Protocol For A Multicentre, Double-Blind, Randomised, Parallel Group Study To Compare The Efficacy and Tolerability Of Celecoxib Vs. Diclofenac In The Treatment Of Subjects With Osteoarthritis Of The Hip Requiring Joint Replacement Therapy
| Verified date | December 2005 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United Kingdom: Research Ethics Committee |
| Study type | Interventional |
To determine if celecoxib 200 mg once daily is as effective as diclofenac 50 mg three times daily in the treatment of pain symptoms associated with osteoarthritis of the hip
| Status | Completed |
| Enrollment | 250 |
| Est. completion date | February 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 45 Years and older |
| Eligibility |
Inclusion Criteria: - Diagnosed with osteoarthritis of hip and requiring joint replacement - Eligible for chronic therapy with an NSAID Exclusion Criteria: - Hip surgery anticipated within 8 calendar weeks after first visit - Active gastrointestinal disease or recent diagnosis of gastrointestinal ulceration (within 60 days of first visit) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Pfizer Investigational Site | Aberdeen | |
| United Kingdom | Pfizer Investigational Site | Amersham | |
| United Kingdom | Pfizer Investigational Site | Ashford | Surrey |
| United Kingdom | Pfizer Investigational Site | Aston Clinton | Bucks |
| United Kingdom | Pfizer Investigational Site | Barnsley | South Yorkshire |
| United Kingdom | Pfizer Investigational Site | Barry | South Glamorgan |
| United Kingdom | Pfizer Investigational Site | Bath | |
| United Kingdom | Pfizer Investigational Site | Bath | |
| United Kingdom | Pfizer Investigational Site | Belfast | |
| United Kingdom | Pfizer Investigational Site | Bradford | |
| United Kingdom | Pfizer Investigational Site | Cardiff | |
| United Kingdom | Pfizer Investigational Site | Carshalton | |
| United Kingdom | Pfizer Investigational Site | Chertsey | |
| United Kingdom | Pfizer Investigational Site | Chingford | London |
| United Kingdom | Pfizer Investigational Site | Edinburgh | |
| United Kingdom | Pfizer Investigational Site | Ely | Cambs |
| United Kingdom | Pfizer Investigational Site | Glasgow | |
| United Kingdom | Pfizer Investigational Site | Greenisland, Carrickfergus | Northern Ireland |
| United Kingdom | Pfizer Investigational Site | Greenock | Renfrewshire |
| United Kingdom | Pfizer Investigational Site | Harrow | Middlesex |
| United Kingdom | Pfizer Investigational Site | Lancaster | England |
| United Kingdom | Pfizer Investigational Site | Lancaster | |
| United Kingdom | Pfizer Investigational Site | Leystonstone, London | |
| United Kingdom | Pfizer Investigational Site | Liverpool | |
| United Kingdom | Pfizer Investigational Site | Liverpool | |
| United Kingdom | Pfizer Investigational Site | London | |
| United Kingdom | Pfizer Investigational Site | Manchester | |
| United Kingdom | Pfizer Investigational Site | Newcastle-Upon-Tyne | Tyne & Wear |
| United Kingdom | Pfizer Investigational Site | Newport | Gwent |
| United Kingdom | Pfizer Investigational Site | Northampton | |
| United Kingdom | Pfizer Investigational Site | Norwich | |
| United Kingdom | Pfizer Investigational Site | Nuneaton | |
| United Kingdom | Pfizer Investigational Site | Oxford | Oxon |
| United Kingdom | Pfizer Investigational Site | Peterborough | |
| United Kingdom | Pfizer Investigational Site | Sheffield | |
| United Kingdom | Pfizer Investigational Site | Sheffield | England |
| United Kingdom | Pfizer Investigational Site | Southampton | |
| United Kingdom | Pfizer Investigational Site | St. Austell | Cornwall |
| United Kingdom | Pfizer Investigational Site | Trowbridge | Wiltshire |
| United Kingdom | Pfizer Investigational Site | Truro | |
| United Kingdom | Pfizer Investigational Site | Wansford | |
| United Kingdom | Pfizer Investigational Site | Watford | |
| United Kingdom | Pfizer Investigational Site | Westbury | |
| United Kingdom | Pfizer Investigational Site | Wigan |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in patient assessment of arthritis pain on walking VAS (Visual Analog Scale) as measured on a 0-100 mm scale at week 6 compared to baseline | |||
| Secondary | Change in patient assessment of arthritis pain on walking VAS (Visual Analog Scale) as measured on a 0-100 mm scale at week 12 compared to baseline. | |||
| Secondary | Change in patients global assessment of arthritis between treatment groups. |
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