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

NCT ID: NCT00418782

Last Updated: 2018-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

naproxen

Intervention Type DRUG

2

Group Type EXPERIMENTAL

CE-224535

Intervention Type DRUG

3

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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naproxen

Intervention Type DRUG

CE-224535

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Anniston, Alabama, United States

Site Status

Pfizer Investigational Site

Bayou La Batre, Alabama, United States

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Pfizer Investigational Site

Birmingham, Alabama, United States

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Pfizer Investigational Site

Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Hot Springs, Arkansas, United States

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Northridge, California, United States

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Sacramento, California, United States

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Tarzana, California, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Westminster, Colorado, United States

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Clearwater, Florida, United States

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DeFuniak Springs, Florida, United States

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Destin, Florida, United States

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Pensacola, Florida, United States

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Chicago, Illinois, United States

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Gurnee, Illinois, United States

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Avon, Indiana, United States

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Indianapolis, Indiana, United States

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Gretna, Louisiana, United States

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Kenner, Louisiana, United States

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Metairie, Louisiana, United States

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Baltimore, Maryland, United States

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Frederick, Maryland, United States

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Flowood, Mississippi, United States

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Columbia, Missouri, United States

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Kansas City, Missouri, United States

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Missoula, Montana, United States

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Trenton, New Jersey, United States

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Beavercreek, Ohio, United States

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Cincinnati, Ohio, United States

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Kettering, Ohio, United States

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Ashland, Oregon, United States

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Eugene, Oregon, United States

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Duncansville, Pennsylvania, United States

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Summerville, South Carolina, United States

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Collierville, Tennessee, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Pfizer Investigational Site

Bryan, Texas, United States

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Pfizer Investigational Site

Longview, Texas, United States

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San Antonio, Texas, United States

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Pfizer Investigational Site

San Antonio, Texas, United States

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Pfizer Investigational Site

Arlington, Virginia, United States

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Pfizer Investigational Site

Spokane, Washington, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6341008&StudyName=A%20Study%20Of%20The%20Effect%20Of%20CE-224535%20On%20Knee%20OA%20%28Osteoarthritis%29%20Pain

To obtain contact information for a study center near you, click here.

Other Identifiers

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A6341008

Identifier Type: -

Identifier Source: org_study_id

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