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Celecoxib Versus Diclofenac In The Treatment Of Osteoarthritis Of The Hip

Primary Purpose

Osteoarthritis, Hip

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Celecoxib
Diclofenac
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

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.

Full Information

First Posted
September 9, 2005
Last Updated
November 30, 2006
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00174317
Brief Title
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

2. Study Status

Record Verification Date
December 2005
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
250 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Celecoxib
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
Title
Change in patients global assessment of arthritis between treatment groups.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Aston Clinton
State/Province
Bucks
ZIP/Postal Code
GP22 5LB
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Ely
State/Province
Cambs
ZIP/Postal Code
CB7 5JD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
St. Austell
State/Province
Cornwall
ZIP/Postal Code
PL26 7DL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Lancaster
State/Province
England
ZIP/Postal Code
LA1 2LG
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Sheffield
State/Province
England
ZIP/Postal Code
S3 9DA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Newport
State/Province
Gwent
ZIP/Postal Code
NP20 4SZ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Chingford
State/Province
London
ZIP/Postal Code
E4 6UN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Harrow
State/Province
Middlesex
ZIP/Postal Code
HA3 7LT
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Greenisland, Carrickfergus
State/Province
Northern Ireland
ZIP/Postal Code
BT38 8TP
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Oxford
State/Province
Oxon
ZIP/Postal Code
OX3 7LD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Greenock
State/Province
Renfrewshire
ZIP/Postal Code
PA16 0XN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Barry
State/Province
South Glamorgan
ZIP/Postal Code
CF62 7EB
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Barnsley
State/Province
South Yorkshire
ZIP/Postal Code
S75 2EP
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Ashford
State/Province
Surrey
ZIP/Postal Code
TW15 3AA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Newcastle-Upon-Tyne
State/Province
Tyne & Wear
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Trowbridge
State/Province
Wiltshire
ZIP/Postal Code
BA14 9AR
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Aberdeen
ZIP/Postal Code
AB15 6XS
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Amersham
ZIP/Postal Code
HP7 0JD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bath
ZIP/Postal Code
BA1 2SR
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bath
ZIP/Postal Code
BA2 4BZ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Belfast
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Cardiff
ZIP/Postal Code
CF23 5SY
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Carshalton
ZIP/Postal Code
SM5 1AA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Chertsey
ZIP/Postal Code
KT16 0PZ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Lancaster
ZIP/Postal Code
LA1 4RP
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Leystonstone, London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Liverpool
ZIP/Postal Code
CH49 5PE
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Northampton
ZIP/Postal Code
NN1 5BD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Norwich
ZIP/Postal Code
NR7 4UY
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Nuneaton
ZIP/Postal Code
CV10 7DJ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Peterborough
ZIP/Postal Code
PE7 3JL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Truro
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Wansford
ZIP/Postal Code
PE8 6PL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Watford
ZIP/Postal Code
WD1 8HB
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Westbury
ZIP/Postal Code
BA13 3JD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Wigan
ZIP/Postal Code
WN6 9EP
Country
United Kingdom

12. IPD Sharing Statement

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Celecoxib Versus Diclofenac In The Treatment Of Osteoarthritis Of The Hip

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