Clinical trial NCT00174317: Celecoxib Versus Diclofenac In The Treatment Of 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis, Hip
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 250
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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)

Primary outcomes:
measure: 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:
measure: 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.
measure: Change in patients global assessment of arthritis between treatment groups.
Other outcomes:
Locations:
city: Aston Clinton
country: United Kingdom
facility: Pfizer Investigational Site
state: Bucks
city: Ely
country: United Kingdom
facility: Pfizer Investigational Site
state: Cambs
city: St. Austell
country: United Kingdom
facility: Pfizer Investigational Site
state: Cornwall
city: Lancaster
country: United Kingdom
facility: Pfizer Investigational Site
state: England
city: Sheffield
country: United Kingdom
facility: Pfizer Investigational Site
state: England
city: Newport
country: United Kingdom
facility: Pfizer Investigational Site
state: Gwent
city: Chingford
country: United Kingdom
facility: Pfizer Investigational Site
state: London
city: Harrow
country: United Kingdom
facility: Pfizer Investigational Site
state: Middlesex
city: Greenisland, Carrickfergus
country: United Kingdom
facility: Pfizer Investigational Site
state: Northern Ireland
city: Oxford
country: United Kingdom
facility: Pfizer Investigational Site
state: Oxon
city: Greenock
country: United Kingdom
facility: Pfizer Investigational Site
state: Renfrewshire
city: Barry
country: United Kingdom
facility: Pfizer Investigational Site
state: South Glamorgan
city: Barnsley
country: United Kingdom
facility: Pfizer Investigational Site
state: South Yorkshire
city: Ashford
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: Newcastle-Upon-Tyne
country: United Kingdom
facility: Pfizer Investigational Site
state: Tyne & Wear
city: Trowbridge
country: United Kingdom
facility: Pfizer Investigational Site
state: Wiltshire
city: Aberdeen
country: United Kingdom
facility: Pfizer Investigational Site
city: Amersham
country: United Kingdom
facility: Pfizer Investigational Site
city: Bath
country: United Kingdom
facility: Pfizer Investigational Site
city: Bath
country: United Kingdom
facility: Pfizer Investigational Site
city: Belfast
country: United Kingdom
facility: Pfizer Investigational Site
city: Bradford
country: United Kingdom
facility: Pfizer Investigational Site
city: Cardiff
country: United Kingdom
facility: Pfizer Investigational Site
city: Carshalton
country: United Kingdom
facility: Pfizer Investigational Site
city: Chertsey
country: United Kingdom
facility: Pfizer Investigational Site
city: Edinburgh
country: United Kingdom
facility: Pfizer Investigational Site
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: Lancaster
country: United Kingdom
facility: Pfizer Investigational Site
city: Leystonstone, London
country: United Kingdom
facility: Pfizer Investigational Site
city: Liverpool
country: United Kingdom
facility: Pfizer Investigational Site
city: Liverpool
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
city: Northampton
country: United Kingdom
facility: Pfizer Investigational Site
city: Norwich
country: United Kingdom
facility: Pfizer Investigational Site
city: Nuneaton
country: United Kingdom
facility: Pfizer Investigational Site
city: Peterborough
country: United Kingdom
facility: Pfizer Investigational Site
city: Sheffield
country: United Kingdom
facility: Pfizer Investigational Site
city: Southampton
country: United Kingdom
facility: Pfizer Investigational Site
city: Truro
country: United Kingdom
facility: Pfizer Investigational Site
city: Wansford
country: United Kingdom
facility: Pfizer Investigational Site
city: Watford
country: United Kingdom
facility: Pfizer Investigational Site
city: Westbury
country: United Kingdom
facility: Pfizer Investigational Site
city: Wigan
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: