Celecoxib Versus Diclofenac In The Treatment Of Osteoarthritis Of The Hip
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
1 other identifier
interventional
250
1 country
44
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2003
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedDecember 5, 2006
December 1, 2005
September 9, 2005
November 30, 2006
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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.
Change in patients global assessment of arthritis between treatment groups.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosed with osteoarthritis of hip and requiring joint replacement
- Eligible for chronic therapy with an NSAID
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (44)
Pfizer Investigational Site
Aston Clinton, Bucks, GP22 5LB, United Kingdom
Pfizer Investigational Site
Ely, Cambs, CB7 5JD, United Kingdom
Pfizer Investigational Site
St Austell, Cornwall, PL26 7DL, United Kingdom
Pfizer Investigational Site
Lancaster, England, LA1 2LG, United Kingdom
Pfizer Investigational Site
Sheffield, England, S3 9DA, United Kingdom
Pfizer Investigational Site
Newport, Gwent, NP20 4SZ, United Kingdom
Pfizer Investigational Site
Chingford, London, E4 6UN, United Kingdom
Pfizer Investigational Site
Harrow, MIDDLESEX, HA3 7LT, United Kingdom
Pfizer Investigational Site
Greenisland, Carrickfergus, Northern Ireland, BT38 8TP, United Kingdom
Pfizer Investigational Site
Oxford, Oxon, OX3 7LD, United Kingdom
Pfizer Investigational Site
Greenock, Renfrewshire, PA16 0XN, United Kingdom
Pfizer Investigational Site
Barry, South Glamorgan, CF62 7EB, United Kingdom
Pfizer Investigational Site
Barnsley, South Yorkshire, S75 2EP, United Kingdom
Pfizer Investigational Site
Ashford, Surrey, TW15 3AA, United Kingdom
Pfizer Investigational Site
Newcastle upon Tyne, Tyne & Wear, NE7 7DN, United Kingdom
Pfizer Investigational Site
Trowbridge, Wiltshire, BA14 9AR, United Kingdom
Pfizer Investigational Site
Aberdeen, AB15 6XS, United Kingdom
Pfizer Investigational Site
Amersham, HP7 0JD, United Kingdom
Pfizer Investigational Site
Bath, BA1 2SR, United Kingdom
Pfizer Investigational Site
Bath, BA2 4BZ, United Kingdom
Pfizer Investigational Site
Belfast, United Kingdom
Pfizer Investigational Site
Bradford, BD9 6RJ, United Kingdom
Pfizer Investigational Site
Cardiff, CF23 5SY, United Kingdom
Pfizer Investigational Site
Carshalton, SM5 1AA, United Kingdom
Pfizer Investigational Site
Chertsey, KT16 0PZ, United Kingdom
Pfizer Investigational Site
Edinburgh, EH4 2XU, United Kingdom
Pfizer Investigational Site
Glasgow, G12 0YN, United Kingdom
Pfizer Investigational Site
Lancaster, LA1 4RP, United Kingdom
Pfizer Investigational Site
Leystonstone, London, E11 1NR, United Kingdom
Pfizer Investigational Site
Liverpool, CH49 5PE, United Kingdom
Pfizer Investigational Site
Liverpool, L9 7AL, United Kingdom
Pfizer Investigational Site
London, SE5 9RS, United Kingdom
Pfizer Investigational Site
Manchester, M8 5RB, United Kingdom
Pfizer Investigational Site
Northampton, NN1 5BD, United Kingdom
Pfizer Investigational Site
Norwich, NR7 4UY, United Kingdom
Pfizer Investigational Site
Nuneaton, CV10 7DJ, United Kingdom
Pfizer Investigational Site
Peterborough, PE7 3JL, United Kingdom
Pfizer Investigational Site
Sheffield, S5 7AU, United Kingdom
Pfizer Investigational Site
Southampton, SO16 6YD, United Kingdom
Pfizer Investigational Site
Truro, TR1 3LJ, United Kingdom
Pfizer Investigational Site
Wansford, PE8 6PL, United Kingdom
Pfizer Investigational Site
Watford, WD1 8HB, United Kingdom
Pfizer Investigational Site
Westbury, BA13 3JD, United Kingdom
Pfizer Investigational Site
Wigan, WN6 9EP, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 15, 2005
Study Start
August 1, 2003
Study Completion
February 1, 2005
Last Updated
December 5, 2006
Record last verified: 2005-12