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Trial record 1 of 1 for:    NCT00418782
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A Study Of The Effect Of CE-224535 On Knee OA (Osteoarthritis) Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00418782
Recruitment Status : Terminated (Results of interim analysis indicate lack of efficacy when compared to placebo.)
First Posted : January 5, 2007
Last Update Posted : December 5, 2018
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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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: naproxen Drug: CE-224535 Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : January 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Active Comparator: 1 Drug: naproxen
Experimental: 2 Drug: CE-224535
Placebo Comparator: 3 Drug: placebo

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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) ]
  2. Patient's Global Impression of Change (PGIC) at Week 2; [ Time Frame: Week 2 ]
  3. 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 ]
  4. The change from Baseline to Week 1 (Day 7) in the WOMAC Pain domain score; [ Time Frame: Day 7 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. The change from Baseline to Weeks 1 and 2 in the Patient's Assessment of Arthritis Pain (VAS) [ Time Frame: Weeks 1 and 2 ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00418782

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United States, Alabama
Pfizer Investigational Site
Anniston, Alabama, United States, 36207
Pfizer Investigational Site
Bayou La Batre, Alabama, United States, 36509
Pfizer Investigational Site
Birmingham, Alabama, United States, 35209
Pfizer Investigational Site
Birmingham, Alabama, United States, 35216
Pfizer Investigational Site
Birmingham, Alabama, United States, 35242
United States, Arkansas
Pfizer Investigational Site
Hot Springs, Arkansas, United States, 71913
United States, California
Pfizer Investigational Site
Northridge, California, United States, 91325
Pfizer Investigational Site
Sacramento, California, United States, 95825
Pfizer Investigational Site
Tarzana, California, United States, 91356
United States, Colorado
Pfizer Investigational Site
Denver, Colorado, United States, 80204
Pfizer Investigational Site
Denver, Colorado, United States, 80206
Pfizer Investigational Site
Westminster, Colorado, United States, 80030
United States, Florida
Pfizer Investigational Site
Clearwater, Florida, United States, 33761
Pfizer Investigational Site
DeFuniak Springs, Florida, United States, 32435
Pfizer Investigational Site
Destin, Florida, United States, 32541
Pfizer Investigational Site
Pensacola, Florida, United States, 32503
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60053
Pfizer Investigational Site
Gurnee, Illinois, United States, 60031
United States, Indiana
Pfizer Investigational Site
Avon, Indiana, United States, 46123
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46250
United States, Louisiana
Pfizer Investigational Site
Gretna, Louisiana, United States, 70056
Pfizer Investigational Site
Kenner, Louisiana, United States, 70065
Pfizer Investigational Site
Metairie, Louisiana, United States, 70002
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21218
Pfizer Investigational Site
Frederick, Maryland, United States, 21702
United States, Mississippi
Pfizer Investigational Site
Flowood, Mississippi, United States, 39232
United States, Missouri
Pfizer Investigational Site
Columbia, Missouri, United States, 65212
Pfizer Investigational Site
Kansas City, Missouri, United States, 64114
United States, Montana
Pfizer Investigational Site
Missoula, Montana, United States, 59802
United States, New Jersey
Pfizer Investigational Site
Trenton, New Jersey, United States, 08611
United States, Ohio
Pfizer Investigational Site
Beavercreek, Ohio, United States, 45440
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45242
Pfizer Investigational Site
Kettering, Ohio, United States, 45429
United States, Oregon
Pfizer Investigational Site
Ashland, Oregon, United States, 97520
Pfizer Investigational Site
Eugene, Oregon, United States, 97404
United States, Pennsylvania
Pfizer Investigational Site
Duncansville, Pennsylvania, United States, 16635
United States, South Carolina
Pfizer Investigational Site
Summerville, South Carolina, United States, 29485
United States, Tennessee
Pfizer Investigational Site
Collierville, Tennessee, United States, 38017
Pfizer Investigational Site
Knoxville, Tennessee, United States, 37909-1900
Pfizer Investigational Site
Memphis, Tennessee, United States, 38104
United States, Texas
Pfizer Investigational Site
Bryan, Texas, United States, 77802
Pfizer Investigational Site
Longview, Texas, United States, 75605
Pfizer Investigational Site
San Antonio, Texas, United States, 78213
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Virginia
Pfizer Investigational Site
Arlington, Virginia, United States, 22205
United States, Washington
Pfizer Investigational Site
Spokane, Washington, United States, 99216
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc Identifier: NCT00418782    
Other Study ID Numbers: A6341008
First Posted: January 5, 2007    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action