Study Stopped
Results of interim analysis indicate lack of efficacy when compared to placebo.
A Study Of The Effect Of CE-224535 On Knee OA (Osteoarthritis) Pain
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
1 other identifier
interventional
212
1 country
46
Brief 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 with OA knee pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2007
Shorter than P25 for phase_2
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 4, 2007
CompletedFirst Posted
Study publicly available on registry
January 5, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedDecember 5, 2018
December 1, 2018
January 4, 2007
December 3, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
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
ongoing
The primary endpoint is the change from Baseline (Day 1) to Week 2 (Day 14) in the WOMAC Pain domain score.
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;
(Days 1 to 6)
Patient's Global Impression of Change (PGIC) at Week 2;
Week 2
The change from Baseline to Weeks 1 and 2 in the Patient's Global Assessment of Arthritic Condition;
Baseline to Weeks 1 and 2
The change from Baseline to Week 1 (Day 7) in the WOMAC Pain domain score;
Day 7
The change from Baseline to Weeks 1 and 2 (Days 7 and 14) in the WOMAC Stiffness domain score;
Days 7 and 14
- +4 more secondary outcomes
Study Arms (3)
1
ACTIVE COMPARATOR2
EXPERIMENTAL3
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (46)
Pfizer Investigational Site
Anniston, Alabama, 36207, United States
Pfizer Investigational Site
Bayou La Batre, Alabama, 36509, United States
Pfizer Investigational Site
Birmingham, Alabama, 35209, United States
Pfizer Investigational Site
Birmingham, Alabama, 35216, United States
Pfizer Investigational Site
Birmingham, Alabama, 35242, United States
Pfizer Investigational Site
Hot Springs, Arkansas, 71913, United States
Pfizer Investigational Site
Northridge, California, 91325, United States
Pfizer Investigational Site
Sacramento, California, 95825, United States
Pfizer Investigational Site
Tarzana, California, 91356, United States
Pfizer Investigational Site
Denver, Colorado, 80204, United States
Pfizer Investigational Site
Denver, Colorado, 80206, United States
Pfizer Investigational Site
Westminster, Colorado, 80030, United States
Pfizer Investigational Site
Clearwater, Florida, 33761, United States
Pfizer Investigational Site
DeFuniak Springs, Florida, 32435, United States
Pfizer Investigational Site
Destin, Florida, 32541, United States
Pfizer Investigational Site
Pensacola, Florida, 32503, United States
Pfizer Investigational Site
Chicago, Illinois, 60053, United States
Pfizer Investigational Site
Gurnee, Illinois, 60031, United States
Pfizer Investigational Site
Avon, Indiana, 46123, United States
Pfizer Investigational Site
Indianapolis, Indiana, 46250, United States
Pfizer Investigational Site
Gretna, Louisiana, 70056, United States
Pfizer Investigational Site
Kenner, Louisiana, 70065, United States
Pfizer Investigational Site
Metairie, Louisiana, 70002, United States
Pfizer Investigational Site
Baltimore, Maryland, 21218, United States
Pfizer Investigational Site
Frederick, Maryland, 21702, United States
Pfizer Investigational Site
Flowood, Mississippi, 39232, United States
Pfizer Investigational Site
Columbia, Missouri, 65212, United States
Pfizer Investigational Site
Kansas City, Missouri, 64114, United States
Pfizer Investigational Site
Missoula, Montana, 59802, United States
Pfizer Investigational Site
Trenton, New Jersey, 08611, United States
Pfizer Investigational Site
Beavercreek, Ohio, 45440, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45242, United States
Pfizer Investigational Site
Kettering, Ohio, 45429, United States
Pfizer Investigational Site
Ashland, Oregon, 97520, United States
Pfizer Investigational Site
Eugene, Oregon, 97404, United States
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635, United States
Pfizer Investigational Site
Summerville, South Carolina, 29485, United States
Pfizer Investigational Site
Collierville, Tennessee, 38017, United States
Pfizer Investigational Site
Knoxville, Tennessee, 37909-1900, United States
Pfizer Investigational Site
Memphis, Tennessee, 38104, United States
Pfizer Investigational Site
Bryan, Texas, 77802, United States
Pfizer Investigational Site
Longview, Texas, 75605, United States
Pfizer Investigational Site
San Antonio, Texas, 78213, United States
Pfizer Investigational Site
San Antonio, Texas, 78229, United States
Pfizer Investigational Site
Arlington, Virginia, 22205, United States
Pfizer Investigational Site
Spokane, Washington, 99216, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 4, 2007
First Posted
January 5, 2007
Study Start
January 1, 2007
Study Completion
August 1, 2007
Last Updated
December 5, 2018
Record last verified: 2018-12