Clinical Trial to Examine the Pain Relief of PH-797804 Alone Or With Naproxen in Subjects With Osteoarthritis of the Knee

NCT ID: NCT01102660

Last Updated: 2014-08-22

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

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-03-31

Brief Summary

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PH-797804 is a potent inhibitor of inflammatory mediators that have a potential role in pain signalling following nerve injury and inflammation. Blocking such mediators may potentially have a therapeutic benefit by reducing pain.

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment Sequence 1

Group Type OTHER

PH-797804

Intervention Type DRUG

Tablet, 6 mg once daily for 2 weeks

Placebo

Intervention Type DRUG

Tablet, 0 mg once daily for 2 weeks

Treatment Sequence 2

Group Type OTHER

Placebo

Intervention Type DRUG

Tablet, 0 mg once daily for 2 weeks

PH-797804

Intervention Type DRUG

Tablet, 6 mg once daily for 2 weeks

Treatment Sequence 3

Group Type OTHER

Naproxen

Intervention Type DRUG

Tablet, 500 mg twice daily for 2 weeks

Naproxen + PH-797804

Intervention Type DRUG

Tablet, 500 mg twice daily for 2 weeks and Tablet, 6 mg once daily for 2 weeks

Treatment Sequence 4

Group Type OTHER

Naproxen + PH-797804

Intervention Type DRUG

Tablet, 500 mg twice daily for 2 weeks and Tablet, 6 mg once daily for 2 weeks

Naproxen

Intervention Type DRUG

Tablet, 500 mg twice daily for 2 weeks

Interventions

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PH-797804

Tablet, 6 mg once daily for 2 weeks

Intervention Type DRUG

Placebo

Tablet, 0 mg once daily for 2 weeks

Intervention Type DRUG

Placebo

Tablet, 0 mg once daily for 2 weeks

Intervention Type DRUG

PH-797804

Tablet, 6 mg once daily for 2 weeks

Intervention Type DRUG

Naproxen

Tablet, 500 mg twice daily for 2 weeks

Intervention Type DRUG

Naproxen + PH-797804

Tablet, 500 mg twice daily for 2 weeks and Tablet, 6 mg once daily for 2 weeks

Intervention Type DRUG

Naproxen + PH-797804

Tablet, 500 mg twice daily for 2 weeks and Tablet, 6 mg once daily for 2 weeks

Intervention Type DRUG

Naproxen

Tablet, 500 mg twice daily for 2 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects between, and including, the ages of 18 and 75 years. Females must be of non-childbearing potential.
* Diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria with X-ray confirmation (a Kellgren-Lawrence X-ray grade of ≥2.

Exclusion Criteria

* History of diseases other than osteoarthritis that may involve the index knee.
* Other severe pain that impairs the assessment of osteoarthritis of pain.
* Electrocardiogram abnormalities.
* History of gastrointestinal disorders.
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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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Paramount, California, United States

Site Status

Pfizer Investigational Site

Spring Valley, California, United States

Site Status

Pfizer Investigational Site

Valley Village, California, United States

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Pfizer Investigational Site

Daytona Beach, Florida, United States

Site Status

Pfizer Investigational Site

Ormond Beach, Florida, United States

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Pfizer Investigational Site

Plantation, Florida, United States

Site Status

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Plantation, Florida, United States

Site Status

Pfizer Investigational Site

South Miami, Florida, United States

Site Status

Pfizer Investigational Site

Gurnee, Illinois, United States

Site Status

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Overland Park, Kansas, United States

Site Status

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Overland Park, Kansas, United States

Site Status

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Overland Park, Kansas, United States

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Prairie Village, Kansas, United States

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Wichita, Kansas, United States

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Fall River, Massachusetts, United States

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Hyannis, Massachusetts, United States

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New Bedford, Massachusetts, United States

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St Louis, Missouri, United States

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Rochester, New York, United States

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Wilmington, North Carolina, United States

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Kettering, Ohio, United States

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Pawtucket, Rhode Island, United States

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Mt. Pleasant, South Carolina, United States

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New Tazewell, Tennessee, United States

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Dallas, Texas, United States

Site Status

Pfizer Investigational Site

San Antonio, Texas, United States

Site Status

Countries

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United States

Related Links

Other Identifiers

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A6631026

Identifier Type: -

Identifier Source: org_study_id

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