Osteoarthritis, KneePhase 4NCT00630929
Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (Europe)
A Phase 4 study testing Ibuprofen and Celecoxib in people with Osteoarthritis, Knee, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 33 sites in 3 countries.
Trial summary
To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Ibuprofen and Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 388 participants
- Where
- 33 sitesin 3 countries
- Study dates
- Jan 2003to Feb 2004
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged >=40 years old
- Diagnosed with OA of the knee according to the American College of Rheumatology and OA in flare state at baseline visit
- Functional capacity class of I-III
Who cannot join
- Inflammatory arthritis or gout or pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
- Acute joint trauma at index joint within the past 3 months with active symptoms
- Score of >=20 on PHQ-9 or score of >=1 on PHQ-9 item i
- Use of mobility assisting device for <6 weeks or use of walker
Trial locations and contacts
33 sites in 3 countries.
33 sites in 3 countries
United Kingdom12 sites
Pfizer Investigational Site
Addlestone, Surrey, KT15 2BH
Pfizer Investigational Site
Cannock, Mid Staffordshire, WS11 2XY
Pfizer Investigational Site
Chelmsly WOOD, Birmingham, B37 7TR
Pfizer Investigational Site
Chorley, Lancs, PR7 1NY
Pfizer Investigational Site
Huddersfield, HD3 3EA
Pfizer Investigational Site
Liverpool, Lancs, L1 9AD
Pfizer Investigational Site
London, NW3 2PF
Pfizer Investigational Site
London, SE5 9RS
Pfizer Investigational Site
Manchester, M41 5SL
Pfizer Investigational Site
Newcastle upon Tyne, NE7 7DN
Pfizer Investigational Site
Truro, Cornwall, TR1 3LJ
Pfizer Investigational Site
Wigan, WN6 9EW
Germany11 sites
Pfizer Investigational Site
Bad Münder am Deister, 31848
Pfizer Investigational Site
Beckum, 59269
Pfizer Investigational Site
Berlin, 10435
Pfizer Investigational Site
Berlin, 10559
Pfizer Investigational Site
Berlin, 12687
Pfizer Investigational Site
Berlin, 13125
Pfizer Investigational Site
Ostseebad Damp, 24351
Pfizer Investigational Site
Schwerin, 19057
Pfizer Investigational Site
Stade, 21680
Pfizer Investigational Site
Tostedt, 21255
Pfizer Investigational Site
Weener, 26826
Spain10 sites
Pfizer Investigational Site
Barcelona, 08029
Pfizer Investigational Site
Barcelona, 08036
Pfizer Investigational Site
Cadiz, 11009
Pfizer Investigational Site
Guadalajara, 19002
Pfizer Investigational Site
Madrid, 28035
Pfizer Investigational Site
Madrid, 28040
Pfizer Investigational Site
Madrid, 28046
Pfizer Investigational Site
Oviedo, 33006
Pfizer Investigational Site
Seville, 41014
Pfizer Investigational Site
Valencia, 46009
About this study
Official title: A Study of the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) and Three Times Daily Ibuprofen vs. Placebo in the Treatment of Subjects With Osteoarthritis of the Knee
To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee.
- Conditions
- Osteoarthritis, Knee
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
800 mg oral tablet 3 times daily with meals for 6 weeks
PlaceboDrug
Matched placebo orally for 6 weeks
CelecoxibDrug
200 mg oral capsule once daily with morning meal for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: Ibuprofen |
| C | Placebo comparator | Not described Receives: Drug: Placebo |
| B | Experimental | Not described Receives: Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in patient's assessment of arthritis pain according to visual analogue scale
Measured: Week 6
Secondary outcomes (11)
Change from baseline in American Pain Society Modified Brief Pain Inventory Short Form pain scores
Measured: Days 1-7
Change from baseline in patient's assessment of arthritis pain according to visual analogue scale
Measured: Week 2
Change from baseline in patient and physician global assessments of arthritis
Measured: Weeks 2 and 6
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index
Measured: Week 6
The Pain Satisfaction Scale
Measured: Week 6
The Patient Health Questionnaire (PHQ-9)
Measured: Week 6
Measurement of upper gastrointestinal tolerability
Measured: Weeks 2 and 6
Adverse events
Measured: Weeks 2 and 6
Laboratory test results
Measured: Week 6
Vital signs
Measured: Weeks 2 and 6
Physical examination
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startJan 2003
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- 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
- Who is masked
- Participant, Investigator
- Enrolment
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630929
- Sponsor's protocol ID
- A3191062
- Status last verified
- Feb 2021
- First submitted
- 28 Feb 2008
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Gordo AC, Walker C, Armada B, Zhou D. Efficacy of celecoxib versus ibuprofen for the treatment of patients with osteoarthritis of the knee: A randomized double-blind, non-inferiority trial. J Int Med Res. 2017 Feb;45(1):59-74. doi: 10.1177/0300060516673707. Epub 2017 Jan 12.
PubMed 28222627
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) and Three Times Daily Ibuprofen vs. Placebo in the Treatment of Subjects With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT00630929
- Acronym / sponsor ID
- A3191062
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2003
- Study completion
- Feb 2004 (actual)
- First posted
- 7 Mar 2008 (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 compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Ibuprofen |
| C | Placebo comparator | Drug: Placebo |
| B | Experimental | Drug: Celecoxib |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged >=40 years old
- Diagnosed with OA of the knee according to the American College of Rheumatology and OA in flare state at baseline visit
- Functional capacity class of I-III
Key exclusion criteria (4 listed)
- Inflammatory arthritis or gout or pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
- Acute joint trauma at index joint within the past 3 months with active symptoms
- Score of >=20 on PHQ-9 or score of >=1 on PHQ-9 item i
- Use of mobility assisting device for <6 weeks or use of walker
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 |
|---|---|---|
| Ibuprofen800 mg oral tablet 3 times daily with meals for 6 weeks | Drug | A |
| PlaceboMatched placebo orally for 6 weeks | Drug | C |
| Celecoxib200 mg oral capsule once daily with morning meal for 6 weeks | Drug | B |
Primary outcome
Change from baseline in patient's assessment of arthritis pain according to visual analogue scale
Time frame: Week 6
11 secondary outcomes
Change from baseline in American Pain Society Modified Brief Pain Inventory Short Form pain scores
Time frame: Days 1-7
Change from baseline in patient's assessment of arthritis pain according to visual analogue scale
Time frame: Week 2
Change from baseline in patient and physician global assessments of arthritis
Time frame: Weeks 2 and 6
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: Week 6
The Pain Satisfaction Scale
Time frame: Week 6
The Patient Health Questionnaire (PHQ-9)
Time frame: Week 6
Measurement of upper gastrointestinal tolerability
Time frame: Weeks 2 and 6
Adverse events
Time frame: Weeks 2 and 6
Laboratory test results
Time frame: Week 6
Vital signs
Time frame: Weeks 2 and 6
Physical examination
Time frame: Week 6
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 21 Feb 2021.
- Derived from this study: PubMed 28222627Gordo AC, Walker C, Armada B, Zhou D. Efficacy of celecoxib versus ibuprofen for the treatment of patients with osteoarthritis of the knee: A randomized double-blind, non-inferiority trial. J Int Med Res. 2017 Feb;45(1):59-74. doi: 10.1177/0300060516673707. Epub 2017 Jan 12.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
33 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ibuprofen and Celecoxib in people with Osteoarthritis, Knee, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 33 sites in 3 countries.
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 3 inclusion and 4 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 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United Kingdom, Germany, Spain. 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. Some participants in this study may receive a placebo. 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 from baseline in patient's assessment of arthritis pain according to visual analogue scale (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00630929, which also lists 1 linked publication.
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 21 Feb 2021.