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

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NCT00418782

Last updated on November 14, 2019
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Study Location
Pfizer Investigational Site
Anniston, Alabama, 36207 United States
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Contact
1-800-718-1021
[email protected]
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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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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 SummaryCE-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 DescriptionNot 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 DateNot 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 CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 2018

ICMJE     Data element required by the

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

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