Osteoarthritis, KneePhase 4CLOAKNCT00643799
Safety and Efficacy of Celecoxib Versus Naproxen in the 6-month Treatment of Knee Osteoarthritis
A Phase 4 study testing Celecoxib and Naproxen in people with Osteoarthritis, Knee, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 51 sites in United States.
Trial summary
To compare the safety and efficacy of celecoxib versus naproxen for the treatment of knee osteoarthritis 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 and Naproxen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 586 participants
- Where
- 51 sitesUnited States
- Study dates
- Mar 2004to Jan 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritis of the knee as defined by the American College of Rheumatology criteria in a flare state at baseline visit
- Functional Capacity Classification of I-III
Who cannot join
- Inflammatory arthritis or gout/pseudo-gout with an acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
- Received acetaminophen within 24 hours of the baseline visit
- Acute joint trauma at index joint within the past 3 months with active symptoms
- History of gastrointestinal (GI) perforation, obstruction, or bleeding
- Diagnosed or treated for GI ulcer within 60 days prior to first dose of study medication
- Received corticosteroids or hyaluronic acid within certain timeframe before study
Trial locations and contacts
51 sites in 1 country.
51 sites in 1 country
United States51 sites
Pfizer Investigational Site
Austin, Texas, 78705
Pfizer Investigational Site
Beachwood, Ohio, 44122
Pfizer Investigational Site
Bethlehem, Pennsylvania, 18015
Pfizer Investigational Site
Buena Park, California, 90620
Pfizer Investigational Site
Clearwater, Florida, 33761
Pfizer Investigational Site
Clinton, Maryland, 20735
Pfizer Investigational Site
Columbus, Ohio, 43124
Pfizer Investigational Site
Columbus, Ohio, 43215
Pfizer Investigational Site
Columbus, Ohio, 43222
Pfizer Investigational Site
Covington, Louisiana, 70433
Pfizer Investigational Site
Dallas, Texas, 75235
Pfizer Investigational Site
DeLand, Florida, 32720
Pfizer Investigational Site
Denver, Colorado, 80230
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635
Pfizer Investigational Site
Flowood, Mississippi, 39232
Pfizer Investigational Site
Greenbelt, Maryland, 20770
Pfizer Investigational Site
Hagerstown, Maryland, 21740
Pfizer Investigational Site
Jacksonville, Florida, 32204
Pfizer Investigational Site
Kansas City, Missouri, 64114
Pfizer Investigational Site
Lansing, Michigan, 48910
Pfizer Investigational Site
Lexington, Kentucky, 40503
Pfizer Investigational Site
Lexington, Kentucky, 40515
Pfizer Investigational Site
Lincoln, Nebraska, 68506
Pfizer Investigational Site
Lincoln, Nebraska, 68516
Pfizer Investigational Site
Media, Pennsylvania, 19603
Pfizer Investigational Site
Metairie, Louisiana, 70006
Pfizer Investigational Site
Miami, Florida, 33186
Pfizer Investigational Site
Milford, Massachusetts, 01757
Pfizer Investigational Site
Montgomery, Alabama, 36106
Pfizer Investigational Site
New York, New York, 10022
Pfizer Investigational Site
Ocala, Florida, 34474
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73103
Pfizer Investigational Site
Orlando, Florida, 32804
Pfizer Investigational Site
Paramount, California, 90723
Pfizer Investigational Site
Pembroke Pines, Florida, 33024
Pfizer Investigational Site
Phoenix, Arizona, 85014
Pfizer Investigational Site
Rancho Mirage, California, 92270
Pfizer Investigational Site
Rockford, Illinois, 61103
Pfizer Investigational Site
Salt Lake City, Utah, 84109
Pfizer Investigational Site
Salt Lake City, Utah, 84121
Pfizer Investigational Site
San Angelo, Texas, 76904
Pfizer Investigational Site
San Diego, California, 92103
Pfizer Investigational Site
San Diego, California, 92108
Pfizer Investigational Site
Tampa, Florida, 33614
Pfizer Investigational Site
Tempe, Arizona, 85282
Pfizer Investigational Site
Warwick, Rhode Island, 02886
Pfizer Investigational Site
Washington D.C., District of Columbia, 20006
Pfizer Investigational Site
Wheaton, Maryland, 20902
Pfizer Investigational Site
Wichita, Kansas, 67207
Pfizer Investigational Site
Wichita, Kansas, 67212
Pfizer Investigational Site
Zephyrhills, Florida, 33542
About this study
Official title: A Randomized, Multicenter, Double-Blind, Double-Dummy Study Comparing the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) and Naproxen 500 mg Twice Daily in the 6-month Treatment of Subjects With Osteoarthritis of the Knee
To compare the safety and efficacy of celecoxib versus naproxen for the treatment of knee osteoarthritis
- Conditions
- Osteoarthritis, Knee
- Being tested
- Celecoxib, Naproxen, 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 months
NaproxenDrug
500 mg oral capsule twice daily for 6 months
PlaceboDrug
Matched oral placebo for 6 months
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Celecoxib |
| B | Active comparator | Not described Receives: Drug: Naproxen |
| C | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of responders, defined as a 20% improvement from baseline in the The Western Ontario MacMaster (WOMAC)Questionnaire Total Score
Measured: Month 6
Secondary outcomes (18)
Number of health care professional contacts
Measured: Throughout study
Patient's and Physician's Satisfaction with Current Arthritis Therapy
Measured: Month 6
Change in WOMAC Total Score from baseline
Measured: Month 6
Change in WOMAC Subscales from baseline
Measured: Month 6
Response in each WOMAC Subscale
Measured: Month 6
Change in Medical Outcome Study sleep scale from baseline
Measured: Month 6
Laboratory tests
Measured: Month 6
Vital signs
Measured: Month 6
Response in VAS
Measured: Month 6
Change in Patient's and Physician's Global Assessment of Pain from baseline
Measured: Month 6
Change in visual analog scale (VAS) from baseline
Measured: Month 6
Adverse events
Measured: Throughout study
Change in Gastrointestinal (GI) Distress Scale from Week 1
Measured: Month 6
Change in GI Distress Scale from time of discontinuation of study drug
Measured: Month 6
Receipt of prescription or over-the-counter gastroprotective agents or pain medications (off study drug)
Measured: Throughout study
Number of hospitalizations, emergency room visits, and procedures
Measured: Throughout study
Change in Work Limitation Questionnaire scale scores from baseline
Measured: Month 6
Physical examination
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startMar 2004
- Primary completionJan 2005
- Study completionJan 2005
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
- 586 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
- NCT00643799
- Sponsor's protocol ID
- A3191152
- Acronym
- CLOAK
- Status last verified
- Jan 2021
- First submitted
- 18 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 Randomized, Multicenter, Double-Blind, Double-Dummy Study Comparing the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) and Naproxen 500 mg Twice Daily in the 6-month Treatment of Subjects With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT00643799
- Acronym / sponsor ID
- CLOAK / A3191152
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 586 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 26 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 naproxen for the treatment of knee osteoarthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Celecoxib |
| B | Active comparator | Drug: Naproxen |
| C | 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)
- Osteoarthritis of the knee as defined by the American College of Rheumatology criteria in a flare state at baseline visit
- Functional Capacity Classification of I-III
Key exclusion criteria (6 listed)
- Inflammatory arthritis or gout/pseudo-gout with an acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
- Received acetaminophen within 24 hours of the baseline visit
- Acute joint trauma at index joint within the past 3 months with active symptoms
- 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 months | Drug | A |
| Naproxen500 mg oral capsule twice daily for 6 months | Drug | B |
| PlaceboMatched oral placebo for 6 months | Drug | C |
Primary outcome
Number of responders, defined as a 20% improvement from baseline in the The Western Ontario MacMaster (WOMAC)Questionnaire Total Score
Time frame: Month 6
18 secondary outcomes
Number of health care professional contacts
Time frame: Throughout study
Patient's and Physician's Satisfaction with Current Arthritis Therapy
Time frame: Month 6
Change in WOMAC Total Score from baseline
Time frame: Month 6
Change in WOMAC Subscales from baseline
Time frame: Month 6
Response in each WOMAC Subscale
Time frame: Month 6
Change in Medical Outcome Study sleep scale from baseline
Time frame: Month 6
Laboratory tests
Time frame: Month 6
Vital signs
Time frame: Month 6
Response in VAS
Time frame: Month 6
Change in Patient's and Physician's Global Assessment of Pain from baseline
Time frame: Month 6
Change in visual analog scale (VAS) from baseline
Time frame: Month 6
Adverse events
Time frame: Throughout study
Change in Gastrointestinal (GI) Distress Scale from Week 1
Time frame: Month 6
Change in GI Distress Scale from time of discontinuation of study drug
Time frame: Month 6
Receipt of prescription or over-the-counter gastroprotective agents or pain medications (off study drug)
Time frame: Throughout study
Number of hospitalizations, emergency room visits, and procedures
Time frame: Throughout study
Change in Work Limitation Questionnaire scale scores from baseline
Time frame: Month 6
Physical examination
Time frame: Month 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 2 Feb 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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
51 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 Naproxen in people with Osteoarthritis, Knee, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 51 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 51 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?
Number of responders, defined as a 20% improvement from baseline in the The Western Ontario MacMaster (WOMAC)Questionnaire Total Score (time frame: Month 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.