OsteoarthritisPhase 2NCT00418782
A Study Of The Effect Of CE-224535 On Knee OA (Osteoarthritis) Pain
A Phase 2 study testing naproxen and CE-224535 in people with Osteoarthritis, run by Pfizer at 46 sites in United States.
Trial summary
CE-224535 is a new medication being developed as an analgesic and anti-inflammatory agent for the treatment of the signs and symptoms of osteoarthritis (OA). The purpose of this study is to evaluate the analgesic and anti inflammatory efficacy and safety of CE 224,535 versus placebo and naproxen treatment in patients… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- naproxen and CE-224535
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 212 participants
- Where
- 46 sitesUnited States
- Study dates
- Jan 2007to Aug 2007
- Phase
- Phase 2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is a healthy adult 18 to 75 years of age, inclusive, in general good health and with diagnosis of knee OA, as determined by the American College of Rheumatology (ACR) clinical/radiographic classification criteria for OA of the knee.
- Women must be of non childbearing potential (amenorrhea for at least 1 year PLUS have a serum follicle stimulating hormone (FSH) level >30 IU/L, bilateral oophorectomy or hysterectomy), and have a confirmed negative serum pregnancy test at the screening visit prior to randomization.
Who cannot join
- History of other diseases that may involve the study joint, including inflammatory joint diseases, crystalline disease, endocrinopathies, metabolic diseases, infections, neuropathic disorders, avascular necrosis, Paget's disease, or tumors.
- Women of childbearing potential, or who are pregnant or lactating.
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
United States46 sites
Pfizer Investigational Site
Anniston, Alabama, 36207
Pfizer Investigational Site
Arlington, Virginia, 22205
Pfizer Investigational Site
Ashland, Oregon, 97520
Pfizer Investigational Site
Avon, Indiana, 46123
Pfizer Investigational Site
Baltimore, Maryland, 21218
Pfizer Investigational Site
Bayou La Batre, Alabama, 36509
Pfizer Investigational Site
Beavercreek, Ohio, 45440
Pfizer Investigational Site
Birmingham, Alabama, 35209
Pfizer Investigational Site
Birmingham, Alabama, 35216
Pfizer Investigational Site
Birmingham, Alabama, 35242
Pfizer Investigational Site
Bryan, Texas, 77802
Pfizer Investigational Site
Chicago, Illinois, 60053
Pfizer Investigational Site
Cincinnati, Ohio, 45242
Pfizer Investigational Site
Clearwater, Florida, 33761
Pfizer Investigational Site
Collierville, Tennessee, 38017
Pfizer Investigational Site
Columbia, Missouri, 65212
Pfizer Investigational Site
DeFuniak Springs, Florida, 32435
Pfizer Investigational Site
Denver, Colorado, 80204
Pfizer Investigational Site
Denver, Colorado, 80206
Pfizer Investigational Site
Destin, Florida, 32541
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635
Pfizer Investigational Site
Eugene, Oregon, 97404
Pfizer Investigational Site
Flowood, Mississippi, 39232
Pfizer Investigational Site
Frederick, Maryland, 21702
Pfizer Investigational Site
Gretna, Louisiana, 70056
Pfizer Investigational Site
Gurnee, Illinois, 60031
Pfizer Investigational Site
Hot Springs, Arkansas, 71913
Pfizer Investigational Site
Indianapolis, Indiana, 46250
Pfizer Investigational Site
Kansas City, Missouri, 64114
Pfizer Investigational Site
Kenner, Louisiana, 70065
Pfizer Investigational Site
Kettering, Ohio, 45429
Pfizer Investigational Site
Knoxville, Tennessee, 37909-1900
Pfizer Investigational Site
Longview, Texas, 75605
Pfizer Investigational Site
Memphis, Tennessee, 38104
Pfizer Investigational Site
Metairie, Louisiana, 70002
Pfizer Investigational Site
Missoula, Montana, 59802
Pfizer Investigational Site
Northridge, California, 91325
Pfizer Investigational Site
Pensacola, Florida, 32503
Pfizer Investigational Site
Sacramento, California, 95825
Pfizer Investigational Site
San Antonio, Texas, 78213
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
Spokane, Washington, 99216
Pfizer Investigational Site
Summerville, South Carolina, 29485
Pfizer Investigational Site
Tarzana, California, 91356
Pfizer Investigational Site
Trenton, New Jersey, 08611
Pfizer Investigational Site
Westminster, Colorado, 80030
About this study
Official title: A 2 Week, Randomized, Double Blind, Placebo And Positive Controlled, Parallel Group, Multicenter Study Of CE-224,535 In Subjects With Osteoarthritic Pain Of The Knee
CE-224535 is a new medication being developed as an analgesic and anti-inflammatory agent for the treatment of the signs and symptoms of osteoarthritis (OA). The purpose of this study is to evaluate the analgesic and anti inflammatory efficacy and safety of CE 224,535 versus placebo and naproxen treatment in patients with OA knee pain.
- Conditions
- Osteoarthritis
- Being tested
- naproxen, CE-224535, placebo
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
naproxenDrug
CE-224535Drug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: naproxen |
| 2 | Experimental | Not described Receives: Drug: CE-224535 |
| 3 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of oral multiple doses of CE 224,535 in subjects with OA of the knee
Measured: ongoing
The primary endpoint is the change from Baseline (Day 1) to Week 2 (Day 14) in the WOMAC Pain domain score.
Measured: Day 1-14
Secondary outcomes (9)
The change from Baseline to each day (Days 1 to 6) and over the average response in Days 1 to 6 using an 11 point numeric rating scale (NRS) from 0-10 on daily pain diary;
Measured: (Days 1 to 6)
Patient's Global Impression of Change (PGIC) at Week 2;
Measured: Week 2
The change from Baseline to Weeks 1 and 2 in the Patient's Global Assessment of Arthritic Condition;
Measured: Baseline to Weeks 1 and 2
The change from Baseline to Week 1 (Day 7) in the WOMAC Pain domain score;
Measured: Day 7
The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Stiffness domain score;
Measured: Days 7 and 14
The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Physical Function domain score;
Measured: Days 7 and 14
The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Total Score by simple summation;
Measured: Days 7 and 14
The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Importance Weighted Total Score;
Measured: Days 7 and 14
The change from Baseline to Weeks 1 and 2 in the Patient's Assessment of Arthritis Pain (VAS)
Measured: Weeks 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2007 (estimated)
- Study startJan 2007
- Study completionAug 2007
Why it stopped: Results of interim analysis indicate lack of efficacy when compared to placebo.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 212 participants (actual)
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
- NCT00418782
- Sponsor's protocol ID
- A6341008
- Status last verified
- Dec 2018
- First submitted
- 4 Jan 2007
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2 Week, Randomized, Double Blind, Placebo And Positive Controlled, Parallel Group, Multicenter Study Of CE-224,535 In Subjects With Osteoarthritic Pain Of The Knee
- ClinicalTrials.gov ID
- NCT00418782
- Acronym / sponsor ID
- A6341008
- Conditions
- Osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Results of interim analysis indicate lack of efficacy when compared to placebo.
- Enrolment
- 212 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Study completion
- Aug 2007 (actual)
- First posted
- 5 Jan 2007 (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.
CE-224535 is a new medication being developed as an analgesic and anti-inflammatory agent for the treatment of the signs and symptoms of osteoarthritis (OA). The purpose of this study is to evaluate the analgesic and anti inflammatory efficacy and safety of CE 224,535 versus placebo and naproxen treatment in patients with OA knee pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: naproxen |
| 2 | Experimental | Drug: CE-224535 |
| 3 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Is a healthy adult 18 to 75 years of age, inclusive, in general good health and with diagnosis of knee OA, as determined by the American College of Rheumatology (ACR) clinical/radiographic classification criteria for OA of the knee.
- Women must be of non childbearing potential (amenorrhea for at least 1 year PLUS have a serum follicle stimulating hormone (FSH) level >30 IU/L, bilateral oophorectomy or hysterectomy), and have a confirmed negative serum pregnancy test at the screening visit prior to randomization.
Key exclusion criteria (2 listed)
- History of other diseases that may involve the study joint, including inflammatory joint diseases, crystalline disease, endocrinopathies, metabolic diseases, infections, neuropathic disorders, avascular necrosis, Paget's disease, or tumors.
- Women of childbearing potential, or who are pregnant or lactating.
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 |
|---|---|---|
| naproxen | Drug | 1 |
| CE-224535 | Drug | 2 |
| placebo | Drug | 3 |
Primary outcome
To determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of oral multiple doses of CE 224,535 in subjects with OA of the knee
Time frame: ongoing
The primary endpoint is the change from Baseline (Day 1) to Week 2 (Day 14) in the WOMAC Pain domain score.
Time frame: Day 1-14
9 secondary outcomes
The change from Baseline to each day (Days 1 to 6) and over the average response in Days 1 to 6 using an 11 point numeric rating scale (NRS) from 0-10 on daily pain diary;
Time frame: (Days 1 to 6)
Patient's Global Impression of Change (PGIC) at Week 2;
Time frame: Week 2
The change from Baseline to Weeks 1 and 2 in the Patient's Global Assessment of Arthritic Condition;
Time frame: Baseline to Weeks 1 and 2
The change from Baseline to Week 1 (Day 7) in the WOMAC Pain domain score;
Time frame: Day 7
The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Stiffness domain score;
Time frame: Days 7 and 14
The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Physical Function domain score;
Time frame: Days 7 and 14
The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Total Score by simple summation;
Time frame: Days 7 and 14
The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Importance Weighted Total Score;
Time frame: Days 7 and 14
The change from Baseline to Weeks 1 and 2 in the Patient's Assessment of Arthritis Pain (VAS)
Time frame: Weeks 1 and 2
Results and safety
The study was stopped early (reason given: Results of interim analysis indicate lack of efficacy when compared to placebo.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- 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
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing naproxen and CE-224535 in people with Osteoarthritis, run by Pfizer at 46 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 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: stopped early, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Results of interim analysis indicate lack of efficacy when compared to placebo.). Results are not available in the source record.
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?
To determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of oral multiple doses of CE 224,535 in subjects with OA of the knee (time frame: ongoing). The study lists 2 primary outcomes in all. 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 2018.