Osteoarthritis, KneePhase 4NCT00620867
Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (United States)
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 United States.
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
- 393 participants
- Where
- 33 sitesUnited States
- Study dates
- Oct 2002to Mar 2003
- 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 1 country.
33 sites in 1 country
United States33 sites
Pfizer Investigational Site
Albuquerque, New Mexico, 87109
Pfizer Investigational Site
Altoona, Pennsylvania, 16601
Pfizer Investigational Site
Anaheim, California, 92804
Pfizer Investigational Site
Anniston, Alabama, 36207
Pfizer Investigational Site
Brooklyn, New York, 11203
Pfizer Investigational Site
Charleston, South Carolina, 29407
Pfizer Investigational Site
Chicago, Illinois, 60610
Pfizer Investigational Site
Cincinnati, Ohio, 45242
Pfizer Investigational Site
Columbus, Ohio, 43124
Pfizer Investigational Site
Dallas, Texas, 75235
Pfizer Investigational Site
Danville, Virginia, 24541
Pfizer Investigational Site
DeLand, Florida, 32720
Pfizer Investigational Site
Edison, New Jersey, 08817
Pfizer Investigational Site
Evansville, Indiana, 47712
Pfizer Investigational Site
Greer, South Carolina, 29651
Pfizer Investigational Site
Jenkintown, Pennsylvania, 19046
Pfizer Investigational Site
Johnson City, Tennessee, 37601
Pfizer Investigational Site
Las Vegas, Nevada, 89102
Pfizer Investigational Site
Layton, Utah, 84041
Pfizer Investigational Site
Long Beach, California, 90806
Pfizer Investigational Site
Miami, Florida, 33186
Pfizer Investigational Site
Mt. Pleasant, South Carolina, 29464
Pfizer Investigational Site
Naples, Florida, 34102
Pfizer Investigational Site
New York, New York, 10022-1009
Pfizer Investigational Site
Newtown, Pennsylvania, 18940
Pfizer Investigational Site
Paramount, California, 90723
Pfizer Investigational Site
Pembroke Pines, Florida, 33024
Pfizer Investigational Site
Phoenix, Arizona, 85051
Pfizer Investigational Site
San Diego, California, 92108
Pfizer Investigational Site
South Plainfield, New Jersey, 07080
Pfizer Investigational Site
St. Petersburg, Florida, 33710
Pfizer Investigational Site
Tulsa, Oklahoma, 74136
Pfizer Investigational Site
Warwick, Rhode Island, 02886
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 three time daily with meals for 6 weeks
celecoxibDrug
200 mg oral capsule once daily with morning meal for 6 weeks
placeboOther
matched placebo orally for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Experimental | Not described Receives: Drug: Ibuprofen |
| Celecoxib | Experimental | Not described Receives: Drug: celecoxib |
| placebo | Placebo comparator | Not described Receives: Other: placebo |
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 (VAS)
Measured: Week 6
Secondary outcomes (9)
Vital signs
Measured: Weeks 2 and 6
Physical examination
Measured: Week 6
Laboratory test results
Measured: Week 6
Adverse events
Measured: Weeks 2 and 6
Change from baseline in patient's and physician's global assessment of pain
Measured: Weeks 2 and 6
Pain Satisfaction Scale
Measured: Days 1-7
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index
Measured: Week 6
Patient Health Questionnaire (PHQ-9)
Measured: Week 6
Change from baseline in patient's assessment of arthritis pain according to VAS
Measured: Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startOct 2002
- Primary completionMar 2003
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 393 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
- NCT00620867
- Sponsor's protocol ID
- A3191063
- Status last verified
- Feb 2021
- First submitted
- 12 Feb 2008
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
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
- NCT00620867
- Acronym / sponsor ID
- A3191063
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 393 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2002
- Primary completion
- Mar 2003 (actual)
- Study completion
- Mar 2003 (actual)
- First posted
- 22 Feb 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 |
|---|---|---|
| Ibuprofen | Experimental | Drug: Ibuprofen |
| Celecoxib | Experimental | Drug: celecoxib |
| placebo | Placebo comparator | Other: placebo |
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 three time daily with meals for 6 weeks | Drug | Ibuprofen |
| celecoxib200 mg oral capsule once daily with morning meal for 6 weeks | Drug | Celecoxib |
| placebomatched placebo orally for 6 weeks | Other | placebo |
Primary outcome
Change from baseline in patient's assessment of arthritis pain according to visual analogue scale (VAS)
Time frame: Week 6
9 secondary outcomes
Vital signs
Time frame: Weeks 2 and 6
Physical examination
Time frame: Week 6
Laboratory test results
Time frame: Week 6
Adverse events
Time frame: Weeks 2 and 6
Change from baseline in patient's and physician's global assessment of pain
Time frame: Weeks 2 and 6
Pain Satisfaction Scale
Time frame: Days 1-7
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: Week 6
Patient Health Questionnaire (PHQ-9)
Time frame: Week 6
Change from baseline in patient's assessment of arthritis pain according to VAS
Time frame: Week 2
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.
- 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 1 country: 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 United States.
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 States. 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 (VAS) (time frame: Week 6). 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 21 Feb 2021.