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

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Anniston, Alabama, 36207 United States
Contact
1-800-718-1021
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.

NCT00418782
Pfizer
Terminated
A Study Of The Effect Of CE-224535 On Knee OA (Osteoarthritis) Pain

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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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis
  • Drug: naproxen
  • Drug: CE-224535
  • Drug: placebo
  • Active Comparator: 1
    Intervention: Drug: naproxen
  • Experimental: 2
    Intervention: Drug: CE-224535
  • Placebo Comparator: 3
    Intervention: Drug: placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
212
August 2007
Not Provided

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00418782
A6341008
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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