Osteoarthritis, HipPhase 4NCT00174317
Celecoxib Versus Diclofenac In The Treatment Of Osteoarthritis Of The Hip
A Phase 4 study testing Celecoxib and Diclofenac in people with Osteoarthritis, Hip, run by Pfizer at 44 sites in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- Celecoxib and Diclofenac
- How many people
- 250 participants
- Where
- 44 sitesUnited Kingdom
- Study dates
- Aug 2003to Feb 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with osteoarthritis of hip and requiring joint replacement
- Eligible for chronic therapy with an NSAID
Who cannot join
- 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)
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United Kingdom44 sites
Pfizer Investigational Site
Aberdeen, AB15 6XS
Pfizer Investigational Site
Amersham, HP7 0JD
Pfizer Investigational Site
Ashford, Surrey, TW15 3AA
Pfizer Investigational Site
Aston Clinton, Bucks, GP22 5LB
Pfizer Investigational Site
Barnsley, South Yorkshire, S75 2EP
Pfizer Investigational Site
Barry, South Glamorgan, CF62 7EB
Pfizer Investigational Site
Bath, BA1 2SR
Pfizer Investigational Site
Bath, BA2 4BZ
Pfizer Investigational Site
Belfast
Pfizer Investigational Site
Bradford, BD9 6RJ
Pfizer Investigational Site
Cardiff, CF23 5SY
Pfizer Investigational Site
Carshalton, SM5 1AA
Pfizer Investigational Site
Chertsey, KT16 0PZ
Pfizer Investigational Site
Chingford, London, E4 6UN
Pfizer Investigational Site
Edinburgh, EH4 2XU
Pfizer Investigational Site
Ely, Cambs, CB7 5JD
Pfizer Investigational Site
Glasgow, G12 0YN
Pfizer Investigational Site
Greenisland, Carrickfergus, Northern Ireland, BT38 8TP
Pfizer Investigational Site
Greenock, Renfrewshire, PA16 0XN
Pfizer Investigational Site
Harrow, MIDDLESEX, HA3 7LT
Pfizer Investigational Site
Lancaster, England, LA1 2LG
Pfizer Investigational Site
Lancaster, LA1 4RP
Pfizer Investigational Site
Leystonstone, London, E11 1NR
Pfizer Investigational Site
Liverpool, CH49 5PE
Pfizer Investigational Site
Liverpool, L9 7AL
Pfizer Investigational Site
London, SE5 9RS
Pfizer Investigational Site
Manchester, M8 5RB
Pfizer Investigational Site
Newcastle upon Tyne, Tyne & Wear, NE7 7DN
Pfizer Investigational Site
Newport, Gwent, NP20 4SZ
Pfizer Investigational Site
Northampton, NN1 5BD
Pfizer Investigational Site
Norwich, NR7 4UY
Pfizer Investigational Site
Nuneaton, CV10 7DJ
Pfizer Investigational Site
Oxford, Oxon, OX3 7LD
Pfizer Investigational Site
Peterborough, PE7 3JL
Pfizer Investigational Site
Sheffield, England, S3 9DA
Pfizer Investigational Site
Sheffield, S5 7AU
Pfizer Investigational Site
Southampton, SO16 6YD
Pfizer Investigational Site
St Austell, Cornwall, PL26 7DL
Pfizer Investigational Site
Trowbridge, Wiltshire, BA14 9AR
Pfizer Investigational Site
Truro, TR1 3LJ
Pfizer Investigational Site
Wansford, PE8 6PL
Pfizer Investigational Site
Watford, WD1 8HB
Pfizer Investigational Site
Westbury, BA13 3JD
Pfizer Investigational Site
Wigan, WN6 9EP
About this study
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
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
- Conditions
- Osteoarthritis, Hip
- Being tested
- Celecoxib, Diclofenac
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
DiclofenacDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startAug 2003
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00174317
- Sponsor's protocol ID
- COXA-0508-261
- Status last verified
- Dec 2005
- First submitted
- 9 Sep 2005
- Last updated
- 5 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00174317
- Acronym / sponsor ID
- COXA-0508-261
- Conditions
- Osteoarthritis, Hip
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Study completion
- Feb 2005
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with osteoarthritis of hip and requiring joint replacement
- Eligible for chronic therapy with an NSAID
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celecoxib | Drug | – |
| Diclofenac | Drug | – |
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
2 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2006.
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Celecoxib and Diclofenac in people with Osteoarthritis, Hip, run by Pfizer at 44 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2006.