Osteoarthritis, KneePhase 4NCT00640627
Efficacy and Safety of Celecoxib Versus Placebo in the Treatment of Patients With Osteoarthritis of the Knee Who Were Unresponsive to Naproxen and Ibuprofen
A Phase 4 study testing Celecoxib in people with Osteoarthritis, Knee, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 30 sites in United States.
Trial summary
To compare the safety and efficacy of celecoxib versus placebo in the treatment of patients with knee osteoarthritis who were unresponsive to treatment with prescription strength naproxen and ibuprofen or who could not tolerate prescription strength naproxen and ibuprofen 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?
- Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 380 participants
- Where
- 30 sitesUnited States
- Study dates
- Dec 2003to Sep 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
- OA of the knee in flare state at baseline visit and functional capacity class of I-III
- Failed adequate trials of both naproxen and ibuprofen (prescription strength) within the past 5 years due to lack of efficacy, tolerability or both; duration of prescription strength ibuprofen and naproxen must have been a minimum of 2 weeks for each drug at the respective recommended doses if failure was due to lack of efficacy, and for any duration if failure was due to lack of tolerability
Who cannot join
- Inflammatory arthritis or gout/pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
- Received acetaminophen within 24 hours of baseline visit
- Use of mobility assisting device for less than six weeks prior to study screening or use of a walker
- History of gastrointestinal (GI) perforation, obstruction, or bleeding
- Diagnosed or treated for GI ulcer within 60 days prior to first dose of study medication
- Recieved corticosteroids or hyaluronic acid within certain timeframe before study
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Pfizer Investigational Site
Albuquerque, New Mexico, 87109
Pfizer Investigational Site
Austin, Texas, 78705
Pfizer Investigational Site
Baltimore, Maryland, 21239
Pfizer Investigational Site
Beaver, Pennsylvania, 15009
Pfizer Investigational Site
Camp Hill, Pennsylvania, 17011
Pfizer Investigational Site
Chesterfield, Missouri, 63017
Pfizer Investigational Site
Colorado Springs, Colorado, 80904
Pfizer Investigational Site
DeLand, Florida, 32720
Pfizer Investigational Site
Flowood, Mississippi, 39232
Pfizer Investigational Site
Greensboro, South Carolina, 27401
Pfizer Investigational Site
Jenkintown, Pennsylvania, 19046
Pfizer Investigational Site
Johnson City, Tennessee, 37601
Pfizer Investigational Site
Long Beach, California, 90806
Pfizer Investigational Site
Mason, Ohio, 45040
Pfizer Investigational Site
Murfreesboro, Tennessee, 37130
Pfizer Investigational Site
Naples, Florida, 34102
Pfizer Investigational Site
Nashville, Tennessee, 37203
Pfizer Investigational Site
New Orleans, Louisiana, 70119
Pfizer Investigational Site
Overland Park, Kansas, 66215
Pfizer Investigational Site
Paramount, California, 90723
Pfizer Investigational Site
Pembroke Pines, Florida, 33024
Pfizer Investigational Site
Phoenix, Arizona, 85051
Pfizer Investigational Site
Reno, Nevada, 89502
Pfizer Investigational Site
San Antonio, Texas, 78217
Pfizer Investigational Site
Seattle, Washington, 98133
Pfizer Investigational Site
St. Petersburg, Florida, 33710
Pfizer Investigational Site
Tucson, Arizona, 85712
Pfizer Investigational Site
Tustin, California, 92780
Pfizer Investigational Site
Wheat Ridge, Colorado, 80033
Pfizer Investigational Site
Woodstock, Georgia, 30189
About this study
Official title: A Double-Blind, Placebo-Controlled Study of the Efficacy and Tolerability of Once Daily Celebrex® (Celecoxib) vs. Placebo in the Treatment of Subjects With Osteoarthritis of the Knee Non-Responsive to Naproxen and Ibuprofen
To compare the safety and efficacy of celecoxib versus placebo in the treatment of patients with knee osteoarthritis who were unresponsive to treatment with prescription strength naproxen and ibuprofen or who could not tolerate prescription strength naproxen and ibuprofen
- Conditions
- Osteoarthritis, Knee
- Being tested
- Celecoxib, Placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
200 mg oral capsule once daily for 6 weeks
PlaceboDrug
Matched oral placebo for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Celecoxib |
| B | Placebo comparator | Not described Receives: Drug: 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 analog scale (VAS)
Measured: Week 6
Secondary outcomes (9)
Western Ontario and McMaster Universities Osteoarthritis Index
Measured: Week 6
Patient's and Physician's Global Assessment of Pain
Measured: Weeks 2 and 6
The Medical Outcomes Study Sleep Scale
Measured: Week 6
Adverse events
Measured: Weeks 0-6
Laboratory tests
Measured: Week 6
Vital signs
Measured: Week 6
Physical examination
Measured: Week 6
Patient's Assessment of Arthritis Pain according to VAS
Measured: Week 2
Serious adverse events
Measured: Up to 30 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startDec 2003
- Study completionSep 2004
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
- 380 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
- NCT00640627
- Sponsor's protocol ID
- A3191069
- Status last verified
- Jan 2021
- First submitted
- 17 Mar 2008
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Study of the Efficacy and Tolerability of Once Daily Celebrex® (Celecoxib) vs. Placebo in the Treatment of Subjects With Osteoarthritis of the Knee Non-Responsive to Naproxen and Ibuprofen
- ClinicalTrials.gov ID
- NCT00640627
- Acronym / sponsor ID
- A3191069
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2003
- Study completion
- Sep 2004 (actual)
- First posted
- 21 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 safety and efficacy of celecoxib versus placebo in the treatment of patients with knee osteoarthritis who were unresponsive to treatment with prescription strength naproxen and ibuprofen or who could not tolerate prescription strength naproxen and ibuprofen
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Celecoxib |
| B | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- OA of the knee in flare state at baseline visit and functional capacity class of I-III
- Failed adequate trials of both naproxen and ibuprofen (prescription strength) within the past 5 years due to lack of efficacy, tolerability or both; duration of prescription strength ibuprofen and naproxen must have been a minimum of 2 weeks for each drug at the respective recommended doses if failure was due to lack of efficacy, and for any duration if failure was due to lack of tolerability
Key exclusion criteria (6 listed)
- Inflammatory arthritis or gout/pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
- Received acetaminophen within 24 hours of baseline visit
- Use of mobility assisting device for less than six weeks prior to study screening or use of a walker
- History of gastrointestinal (GI) perforation, obstruction, or bleeding
- Diagnosed or treated for GI ulcer within 60 days prior to first dose of study medication
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 |
|---|---|---|
| Celecoxib200 mg oral capsule once daily for 6 weeks | Drug | A |
| PlaceboMatched oral placebo for 6 weeks | Drug | B |
Primary outcome
Change from baseline in Patient's Assessment of Arthritis Pain, according to visual analog scale (VAS)
Time frame: Week 6
9 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: Week 6
Patient's and Physician's Global Assessment of Pain
Time frame: Weeks 2 and 6
The Medical Outcomes Study Sleep Scale
Time frame: Week 6
Adverse events
Time frame: Weeks 0-6
Laboratory tests
Time frame: Week 6
Vital signs
Time frame: Week 6
Physical examination
Time frame: Week 6
Patient's Assessment of Arthritis Pain according to VAS
Time frame: Week 2
Serious adverse events
Time frame: Up to 30 days after last dose
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 2 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
30 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 in people with Osteoarthritis, Knee, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 30 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 2 inclusion and 6 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 2 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 30 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 analog 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 2 Feb 2021.