Celecoxib Versus Diclofenac In The Treatment Of Osteoarthritis Of The Hip

Condition(s) targeted: Osteoarthritis, Hip

Intervention: Celecoxib (Drug); Diclofenac (Drug)

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 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

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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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 outcome:

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.

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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)

Pfizer Investigational Site, Bath BA2 4BZ, United Kingdom

Pfizer Investigational Site, Liverpool L9 7AL, United Kingdom

Pfizer Investigational Site, Glasgow G12 0YN, United Kingdom

Pfizer Investigational Site, Liverpool CH49 5PE, United Kingdom

Pfizer Investigational Site, London SE5 9RS, United Kingdom

Pfizer Investigational Site, Belfast, United Kingdom

Pfizer Investigational Site, Amersham HP7 0JD, United Kingdom

Pfizer Investigational Site, Manchester M8 5RB, United Kingdom

Pfizer Investigational Site, Southampton SO16 6YD, United Kingdom

Pfizer Investigational Site, Edinburgh EH4 2XU, United Kingdom

Pfizer Investigational Site, TRURO TR1 3LJ, United Kingdom

Pfizer Investigational Site, Sheffield S5 7AU, United Kingdom

Pfizer Investigational Site, Watford WD1 8HB, United Kingdom

Pfizer Investigational Site, Norwich NR7 4UY, United Kingdom

Pfizer Investigational Site, Aberdeen AB15 6XS, United Kingdom

Pfizer Investigational Site, Bath BA1 2SR, United Kingdom

Pfizer Investigational Site, Wigan WN6 9EP, United Kingdom

Pfizer Investigational Site, Leystonstone, London E11 1NR, United Kingdom

Pfizer Investigational Site, Westbury BA13 3JD, United Kingdom

Pfizer Investigational Site, Northampton NN1 5BD, United Kingdom

Pfizer Investigational Site, Lancaster LA1 4RP, United Kingdom

Pfizer Investigational Site, Peterborough PE7 3JL, United Kingdom

Pfizer Investigational Site, Cardiff CF23 5SY, United Kingdom

Pfizer Investigational Site, Wansford PE8 6PL, United Kingdom

Pfizer Investigational Site, Bradford BD9 6RJ, United Kingdom

Pfizer Investigational Site, Carshalton SM5 1AA, United Kingdom

Pfizer Investigational Site, Nuneaton CV10 7DJ, United Kingdom

Pfizer Investigational Site, Chertsey KT16 0PZ, United Kingdom

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, Sheffield, ENGLAND S3 9DA, United Kingdom

Pfizer Investigational Site, Lancaster, ENGLAND LA1 2LG, 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

Link to Clinicalstudyresults.org posting

Starting date: August 2003
Ending date: February 2005
Last updated: November 30, 2006