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A Phase II Study Looking at Moderate to Severe Osteoarthritis Knee Pain

NCT ID: NCT00394563

Last Updated: 2009-10-12

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-10-31

Brief Summary

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The purpose of this study is to look at the effects of RN624 on moderate to severe knee pain due to osteoarthritis. This study will look at the safety and pain relieving effects of RN624 compared to placebo over a 4 month period.

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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

monoclonal antibody

Group Type EXPERIMENTAL

RN624 (PF-04383119)

Intervention Type DRUG

10 mcg/kg

2

Group Type EXPERIMENTAL

RN624 (PF-04383119)

Intervention Type DRUG

25 mcg/kg

3

Group Type EXPERIMENTAL

RN624 (PF-04383119)

Intervention Type DRUG

50 mcg/kg

4

Group Type EXPERIMENTAL

RN624 (PF-04383119)

Intervention Type DRUG

100 mcg/kg

5

Group Type EXPERIMENTAL

RN624 (PF-04383119)

Intervention Type DRUG

200 mcg/kg

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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RN624 (PF-04383119)

10 mcg/kg

Intervention Type DRUG

RN624 (PF-04383119)

25 mcg/kg

Intervention Type DRUG

RN624 (PF-04383119)

50 mcg/kg

Intervention Type DRUG

RN624 (PF-04383119)

100 mcg/kg

Intervention Type DRUG

RN624 (PF-04383119)

200 mcg/kg

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Male or non-pregnant female aged 40-75 with chronic moderate to severe knee pain due to OA (scoring 50 out of 100 on a visual analog scale on knee pain).

Subjects must meet one of the following: unwilling to take non-opiate pain medications, or for whom non-opiate pain medications have failed, or are candidates for or seeking invasive interventions such as intraarticular injections, knee arthroplasty, or total knee surgery

Exclusion Criteria

History or symptoms of autoimmune disorders, cancer within the last 5 years except for cutaneous basal cell or squamous cell cancer resolved by excision, allergic reaction to monoclonal antibodies or IgG-fusion proteins, Hepatitis B, C or HIV, drug abuse, fibromyalgia, clinically significant cardiac disease, diabetes mellitus requiring oral treatment or insulin, clinically significant neurological disease or clinically significant psychiatric disorders
Minimum Eligible Age

40 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

Birmingham, Alabama, United States

Site Status

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Anaheim, California, United States

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Cypress, California, United States

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National City, California, United States

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Sacremento, California, United States

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Stamford, Connecticut, United States

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Waterbury, Connecticut, United States

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Daytona Beach, Florida, United States

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North Miami, Florida, United States

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Ocala, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Honolulu, Hawaii, United States

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Honolulu, Hawaii, United States

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Boise, Idaho, United States

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Evansville, Indiana, United States

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Merrillville, Indiana, United States

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Louisville, Kentucky, United States

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Baltimore, Maryland, United States

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Wheaton, Maryland, United States

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Worcester, Massachusetts, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Reno, Nevada, United States

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Albuquerque, New Mexico, United States

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Rochester, New York, United States

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Charlotte, North Carolina, United States

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Charlotte, North Carolina, United States

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Greensboro, North Carolina, United States

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Raleigh, North Carolina, United States

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Columbus, Ohio, United States

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Zanesville, Ohio, United States

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Portland, Oregon, United States

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Bethlehem, Pennsylvania, United States

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Duncansville, Pennsylvania, United States

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Greer, South Carolina, United States

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Jackson, Tennessee, United States

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Knoxville, Tennessee, United States

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Austin, Texas, United States

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San Antonio, Texas, United States

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Midvale, Utah, United States

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Charlottesville, Virginia, United States

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Yakima, Washington, United States

Site Status

Countries

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United States

References

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Lane NE, Schnitzer TJ, Birbara CA, Mokhtarani M, Shelton DL, Smith MD, Brown MT. Tanezumab for the treatment of pain from osteoarthritis of the knee. N Engl J Med. 2010 Oct 14;363(16):1521-31. doi: 10.1056/NEJMoa0901510. Epub 2010 Sep 29.

Reference Type DERIVED
PMID: 20942668 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4091008&StudyName=A%20Phase%20II%20Study%20Looking%20at%20Moderate%20to%20Severe%20Osteoarthritis%20Knee%20Pain

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

Other Identifiers

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RN624-CL006

Identifier Type: -

Identifier Source: secondary_id

A4091008

Identifier Type: -

Identifier Source: org_study_id

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