NCT00174317

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2003

Geographic Reach
1 country

44 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

December 5, 2006

Status Verified

December 1, 2005

First QC Date

September 9, 2005

Last Update Submit

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

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (44)

Pfizer Investigational Site

Aston Clinton, Bucks, GP22 5LB, United Kingdom

Location

Pfizer Investigational Site

Ely, Cambs, CB7 5JD, United Kingdom

Location

Pfizer Investigational Site

St Austell, Cornwall, PL26 7DL, United Kingdom

Location

Pfizer Investigational Site

Lancaster, England, LA1 2LG, United Kingdom

Location

Pfizer Investigational Site

Sheffield, England, S3 9DA, United Kingdom

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Pfizer Investigational Site

Newport, Gwent, NP20 4SZ, United Kingdom

Location

Pfizer Investigational Site

Chingford, London, E4 6UN, United Kingdom

Location

Pfizer Investigational Site

Harrow, MIDDLESEX, HA3 7LT, United Kingdom

Location

Pfizer Investigational Site

Greenisland, Carrickfergus, Northern Ireland, BT38 8TP, United Kingdom

Location

Pfizer Investigational Site

Oxford, Oxon, OX3 7LD, United Kingdom

Location

Pfizer Investigational Site

Greenock, Renfrewshire, PA16 0XN, United Kingdom

Location

Pfizer Investigational Site

Barry, South Glamorgan, CF62 7EB, United Kingdom

Location

Pfizer Investigational Site

Barnsley, South Yorkshire, S75 2EP, United Kingdom

Location

Pfizer Investigational Site

Ashford, Surrey, TW15 3AA, United Kingdom

Location

Pfizer Investigational Site

Newcastle upon Tyne, Tyne & Wear, NE7 7DN, United Kingdom

Location

Pfizer Investigational Site

Trowbridge, Wiltshire, BA14 9AR, United Kingdom

Location

Pfizer Investigational Site

Aberdeen, AB15 6XS, United Kingdom

Location

Pfizer Investigational Site

Amersham, HP7 0JD, United Kingdom

Location

Pfizer Investigational Site

Bath, BA1 2SR, United Kingdom

Location

Pfizer Investigational Site

Bath, BA2 4BZ, United Kingdom

Location

Pfizer Investigational Site

Belfast, United Kingdom

Location

Pfizer Investigational Site

Bradford, BD9 6RJ, United Kingdom

Location

Pfizer Investigational Site

Cardiff, CF23 5SY, United Kingdom

Location

Pfizer Investigational Site

Carshalton, SM5 1AA, United Kingdom

Location

Pfizer Investigational Site

Chertsey, KT16 0PZ, United Kingdom

Location

Pfizer Investigational Site

Edinburgh, EH4 2XU, United Kingdom

Location

Pfizer Investigational Site

Glasgow, G12 0YN, United Kingdom

Location

Pfizer Investigational Site

Lancaster, LA1 4RP, United Kingdom

Location

Pfizer Investigational Site

Leystonstone, London, E11 1NR, United Kingdom

Location

Pfizer Investigational Site

Liverpool, CH49 5PE, United Kingdom

Location

Pfizer Investigational Site

Liverpool, L9 7AL, United Kingdom

Location

Pfizer Investigational Site

London, SE5 9RS, United Kingdom

Location

Pfizer Investigational Site

Manchester, M8 5RB, United Kingdom

Location

Pfizer Investigational Site

Northampton, NN1 5BD, United Kingdom

Location

Pfizer Investigational Site

Norwich, NR7 4UY, United Kingdom

Location

Pfizer Investigational Site

Nuneaton, CV10 7DJ, United Kingdom

Location

Pfizer Investigational Site

Peterborough, PE7 3JL, United Kingdom

Location

Pfizer Investigational Site

Sheffield, S5 7AU, United Kingdom

Location

Pfizer Investigational Site

Southampton, SO16 6YD, United Kingdom

Location

Pfizer Investigational Site

Truro, TR1 3LJ, United Kingdom

Location

Pfizer Investigational Site

Wansford, PE8 6PL, United Kingdom

Location

Pfizer Investigational Site

Watford, WD1 8HB, United Kingdom

Location

Pfizer Investigational Site

Westbury, BA13 3JD, United Kingdom

Location

Pfizer Investigational Site

Wigan, WN6 9EP, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

CelecoxibDiclofenac

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenylacetatesAcids, CarbocyclicCarboxylic Acids

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

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

Locations