A Study Of The Effect Of CE-224535 On Knee OA (Osteoarthritis) Pain

NCT00418782

Last updated date
Study Location
Pfizer Investigational Site
Anniston, Alabama, 36207, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

OsteoarthritisStudy Evaluating AGG-523 in Subjects With Severe Osteoarthritis Requiring Total Knee Replacement NCT00454298
  1. Boston, Massachusetts
  2. Boston, Massachusetts
  3. Newton, Massachusetts
  4. Winchester, Massachusetts
  5. Worcester, Massachusetts
ALL GENDERS
55 Years+
years
MULTIPLE SITES
OsteoarthritisClinical Trial to Examine the Pain Relief of PH-797804 Alone Or With Naproxen in Subjects With Osteoarthritis of the Knee NCT01102660
  1. Paramount, California
  2. Spring Valley, California
  3. Valley Village, California
  4. Daytona Beach, Florida
  5. Ormond Beach, Florida
  6. Plantation, Florida
  7. Plantation, Florida
  8. South Miami, Florida
  9. Gurnee, Illinois
  10. Overland Park, Kansas
  11. Overland Park, Kansas
  12. Overland Park, Kansas
  13. Prairie Village, Kansas
  14. Wichita, Kansas
  15. Fall River, Massachusetts
  16. Hyannis, Massachusetts
  17. New Bedford, Massachusetts
  18. St. Louis, Missouri
  19. Rochester, New York
  20. Wilmington, North Carolina
  21. Kettering, Ohio
  22. Pawtucket, Rhode Island
  23. Mt. Pleasant, South Carolina
  24. New Tazewell, Tennessee
  25. Dallas, Texas
  26. San Antonio, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
OsteoarthritisA Study Of The Effect Of CE-224535 On Knee OA (Osteoarthritis) Pain NCT00418782
  1. Anniston, Alabama
  2. Bayou La Batre, Alabama
  3. Birmingham, Alabama
  4. Birmingham, Alabama
  5. Birmingham, Alabama
  6. Hot Springs, Arkansas
  7. Northridge, California
  8. Sacramento, California
  9. Tarzana, California
  10. Denver, Colorado
  11. Denver, Colorado
  12. Westminster, Colorado
  13. Clearwater, Florida
  14. DeFuniak Springs, Florida
  15. Destin, Florida
  16. Pensacola, Florida
  17. Chicago, Illinois
  18. Gurnee, Illinois
  19. Avon, Indiana
  20. Indianapolis, Indiana
  21. Gretna, Louisiana
  22. Kenner, Louisiana
  23. Metairie, Louisiana
  24. Baltimore, Maryland
  25. Frederick, Maryland
  26. Flowood, Mississippi
  27. Columbia, Missouri
  28. Kansas City, Missouri
  29. Missoula, Montana
  30. Trenton, New Jersey
  31. Beavercreek, Ohio
  32. Cincinnati, Ohio
  33. Kettering, Ohio
  34. Ashland, Oregon
  35. Eugene, Oregon
  36. Duncansville, Pennsylvania
  37. Summerville, South Carolina
  38. Collierville, Tennessee
  39. Knoxville, Tennessee
  40. Memphis, Tennessee
  41. Bryan, Texas
  42. Longview, Texas
  43. San Antonio, Texas
  44. San Antonio, Texas
  45. Arlington, Virginia
  46. Spokane, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
OsteoarthritisMeasuring Gait And Self-Reported Pain In Patients With Osteoarthritis Of The Knee Using Placebo/Oxycodone/Celecoxib. NCT00484718
  1. Palo Alto, California
  2. Stanford, California
ALL GENDERS
40 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of The Effect Of CE-224535 On Knee OA (Osteoarthritis) Pain
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Drug: naproxen
  • Drug: CE-224535
  • Drug: placebo
Study Arms  ICMJE
  • Active Comparator: 1
    Intervention: Drug: naproxen
  • Experimental: 2
    Intervention: Drug: CE-224535
  • Placebo Comparator: 3
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 29, 2008)
212
Original Enrollment  ICMJE
 (submitted: January 4, 2007)
300
Actual Study Completion Date  ICMJE August 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00418782
Other Study ID Numbers  ICMJE A6341008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP