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A Study Of The Safety And Efficacy Of PF-04191834 In Patients With Osteoarthritis Of The Knee

NCT ID: NCT01147458

Last Updated: 2013-06-06

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-02-28

Brief Summary

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PF-04191834 works in animal models by inhibiting one of the enzymes, 5-lipoxygenasein which is involved in the pathway that causes inflammation and pain. The purpose of this study is to test how effective, safe and tolerated PF-04191834 is in patients with osteoarthritis of the knee by itself or with naproxen, particularly to test if patients have less pain.

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Detailed Description

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This study has been terminated in response to a reported serious adverse event (SAE). The sponsor's assessment of the limited data available at the time of the initial SAE report was that the SAE may alter the potential benefit - risk profile of the study medication.

Conditions

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Osteoarthritis, Knee

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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PF-04191834 followed by placebo

PF-04191834 600 mg BID dose followed by matched placebo plus naproxen placebo.

Group Type EXPERIMENTAL

PF-04191834

Intervention Type DRUG

100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks

PF-04191834 placebo

Intervention Type DRUG

Matching PF-04191834 placebo tablets to be administered BID for two weeks

Naproxen placebo

Intervention Type DRUG

Matching naproxen placebo tablets to be administered BID for 4 weeks

Placebo followed by PF-04191834

Placebo followed by 600 mg BID dose of PF-04191834 plus naproxen placebo.

Group Type EXPERIMENTAL

PF-04191834 placebo

Intervention Type DRUG

Matching PF-04191834 placebo tablets to be administered BID for two weeks

PF-04191834

Intervention Type DRUG

100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks

Naproxen placebo

Intervention Type DRUG

Matching naproxen placebo tablets to be administered BID for 4 weeks

PF-04191834+Naproxen followed by Naproxen

PF-04191834 600 mg BID + Naproxen 500 mg BID followed by Naproxen 500 mg BID plus PF-04191834 placebo

Group Type EXPERIMENTAL

PF-04191834

Intervention Type DRUG

100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks

Naproxen

Intervention Type DRUG

Naproxen 500 mg tablet administered BID for a total of four weeks

PF-04191834 placebo

Intervention Type DRUG

Matching PF-04191834 placebo tablets to be administered BID for two weeks

Naproxen followed by PF-04191834+Naproxen

Naproxen 500 mg BID followed by PF-04191834 600 mg BID + Naproxen 500 mg BID

Group Type EXPERIMENTAL

Naproxen

Intervention Type DRUG

Naproxen 500 mg tablet administered BID for a total of four weeks

PF-04191834 placebo

Intervention Type DRUG

Matching PF-04191834 placebo tablets to be administered BID for two weeks

PF-04191834

Intervention Type DRUG

100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks

Interventions

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PF-04191834

100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks

Intervention Type DRUG

PF-04191834 placebo

Matching PF-04191834 placebo tablets to be administered BID for two weeks

Intervention Type DRUG

Naproxen placebo

Matching naproxen placebo tablets to be administered BID for 4 weeks

Intervention Type DRUG

PF-04191834 placebo

Matching PF-04191834 placebo tablets to be administered BID for two weeks

Intervention Type DRUG

PF-04191834

100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks

Intervention Type DRUG

Naproxen placebo

Matching naproxen placebo tablets to be administered BID for 4 weeks

Intervention Type DRUG

PF-04191834

100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks

Intervention Type DRUG

Naproxen

Naproxen 500 mg tablet administered BID for a total of four weeks

Intervention Type DRUG

PF-04191834 placebo

Matching PF-04191834 placebo tablets to be administered BID for two weeks

Intervention Type DRUG

Naproxen

Naproxen 500 mg tablet administered BID for a total of four weeks

Intervention Type DRUG

PF-04191834 placebo

Matching PF-04191834 placebo tablets to be administered BID for two weeks

Intervention Type DRUG

PF-04191834

100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects must have a diagnosis of osteoarthritis based on the American College of Rheumatology criteria confirmed by an X-ray
* Subjects must be willing and able to stop all current pain therapy for the duration of the study
* Subjects must be willing and able to complete a daily diary

Exclusion Criteria

* BMI of \>39 kg/m2
* Known allergy or hypersensitivity to naproxen
* Any condition or medical history that might interfere with the subject's ability to complete the study visits and assessments
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

Peoria, Arizona, United States

Site Status

Pfizer Investigational Site

Phoenix, Arizona, United States

Site Status

Pfizer Investigational Site

Phoenix, Arizona, United States

Site Status

Pfizer Investigational Site

Anaheim, California, United States

Site Status

Pfizer Investigational Site

Carmichael, California, United States

Site Status

Pfizer Investigational Site

Fair Oaks, California, United States

Site Status

Pfizer Investigational Site

San Diego, California, United States

Site Status

Pfizer Investigational Site

Denver, Colorado, United States

Site Status

Pfizer Investigational Site

DeLand, Florida, United States

Site Status

Pfizer Investigational Site

Pensacola, Florida, United States

Site Status

Pfizer Investigational Site

South Miami, Florida, United States

Site Status

Pfizer Investigational Site

South Bend, Indiana, United States

Site Status

Pfizer Investigational Site

Overland Park, Kansas, United States

Site Status

Pfizer Investigational Site

Overland Park, Kansas, United States

Site Status

Pfizer Investigational Site

Worcester, Massachusetts, United States

Site Status

Pfizer Investigational Site

Edina, Minnesota, United States

Site Status

Pfizer Investigational Site

Saint Paul, Minnesota, United States

Site Status

Pfizer Investigational Site

Las Vegas, Nevada, United States

Site Status

Pfizer Investigational Site

Monroe, North Carolina, United States

Site Status

Pfizer Investigational Site

Fargo, North Dakota, United States

Site Status

Pfizer Investigational Site

Columbus, Ohio, United States

Site Status

Pfizer Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

Pfizer Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Austin, Texas, United States

Site Status

Pfizer Investigational Site

Arlington, Virginia, United States

Site Status

Pfizer Investigational Site

St. John's, Newfoundland and Labrador, Canada

Site Status

Pfizer Investigational Site

Québec, Quebec, Canada

Site Status

Pfizer Investigational Site

Québec, Quebec, Canada

Site Status

Pfizer Investigational Site

Sherbrooke, Quebec, Canada

Site Status

Pfizer Investigational Site

Gothenburg, , Sweden

Site Status

Pfizer Investigational Site

Stockholm, , Sweden

Site Status

Countries

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United States Canada Sweden

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0041007&StudyName=A%20Study%20Of%20The%20Safety%20And%20Efficacy%20Of%20PF-04191834%20In%20Patients%20With%20Osteoarthritis%20Of%20The%20Knee

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

Other Identifiers

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B0041007

Identifier Type: -

Identifier Source: org_study_id

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