Celecoxib Versus Diclofenac In The Treatment Of Osteoarthritis Of The Hip - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00174317

Purpose

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

Condition	Intervention	Phase
Osteoarthritis, Hip	Drug: Celecoxib Drug: Diclofenac	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac Celecoxib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 Measures:

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.

Estimated Enrollment:	250
Study Start Date:	August 2003
Estimated Study Completion Date:	February 2005

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174317

Locations

United Kingdom
Pfizer Investigational Site
Aston Clinton, Bucks, United Kingdom, GP22 5LB
Pfizer Investigational Site
Ely, Cambs, United Kingdom, CB7 5JD
Pfizer Investigational Site
St. Austell, Cornwall, United Kingdom, PL26 7DL
Pfizer Investigational Site
Lancaster, England, United Kingdom, LA1 2LG
Pfizer Investigational Site
Sheffield, England, United Kingdom, S3 9DA
Pfizer Investigational Site
Newport, Gwent, United Kingdom, NP20 4SZ
Pfizer Investigational Site
Chingford, London, United Kingdom, E4 6UN
Pfizer Investigational Site
Harrow, Middlesex, United Kingdom, HA3 7LT
Pfizer Investigational Site
Greenisland, Carrickfergus, Northern Ireland, United Kingdom, BT38 8TP
Pfizer Investigational Site
Oxford, Oxon, United Kingdom, OX3 7LD
Pfizer Investigational Site
Greenock, Renfrewshire, United Kingdom, PA16 0XN
Pfizer Investigational Site
Barry, South Glamorgan, United Kingdom, CF62 7EB
Pfizer Investigational Site
Barnsley, South Yorkshire, United Kingdom, S75 2EP
Pfizer Investigational Site
Ashford, Surrey, United Kingdom, TW15 3AA
Pfizer Investigational Site
Newcastle-Upon-Tyne, Tyne & Wear, United Kingdom, NE7 7DN
Pfizer Investigational Site
Trowbridge, Wiltshire, United Kingdom, BA14 9AR
Pfizer Investigational Site
Aberdeen, United Kingdom, AB15 6XS
Pfizer Investigational Site
Amersham, United Kingdom, HP7 0JD
Pfizer Investigational Site
Bath, United Kingdom, BA2 4BZ
Pfizer Investigational Site
Bath, United Kingdom, BA1 2SR
Pfizer Investigational Site
Belfast, United Kingdom
Pfizer Investigational Site
Bradford, United Kingdom, BD9 6RJ
Pfizer Investigational Site
Cardiff, United Kingdom, CF23 5SY
Pfizer Investigational Site
Carshalton, United Kingdom, SM5 1AA
Pfizer Investigational Site
Chertsey, United Kingdom, KT16 0PZ
Pfizer Investigational Site
Edinburgh, United Kingdom, EH4 2XU
Pfizer Investigational Site
Glasgow, United Kingdom, G12 0YN
Pfizer Investigational Site
Lancaster, United Kingdom, LA1 4RP
Pfizer Investigational Site
Leystonstone, London, United Kingdom, E11 1NR
Pfizer Investigational Site
Liverpool, United Kingdom, CH49 5PE
Pfizer Investigational Site
Liverpool, United Kingdom, L9 7AL
Pfizer Investigational Site
London, United Kingdom, SE5 9RS
Pfizer Investigational Site
Manchester, United Kingdom, M8 5RB
Pfizer Investigational Site
Northampton, United Kingdom, NN1 5BD
Pfizer Investigational Site
Norwich, United Kingdom, NR7 4UY
Pfizer Investigational Site
Nuneaton, United Kingdom, CV10 7DJ
Pfizer Investigational Site
Peterborough, United Kingdom, PE7 3JL
Pfizer Investigational Site
Sheffield, United Kingdom, S5 7AU
Pfizer Investigational Site
Southampton, United Kingdom, SO16 6YD
Pfizer Investigational Site
Truro, United Kingdom, TR1 3LJ
Pfizer Investigational Site
Wansford, United Kingdom, PE8 6PL
Pfizer Investigational Site
Watford, United Kingdom, WD1 8HB
Pfizer Investigational Site
Westbury, United Kingdom, BA13 3JD
Pfizer Investigational Site
Wigan, United Kingdom, WN6 9EP

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00174317 History of Changes
Other Study ID Numbers:	COXA-0508-261
Study First Received:	September 9, 2005
Last Updated:	November 30, 2006
Health Authority:	United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Diclofenac
Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on February 07, 2012