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A Study To Investigate Whether PF-04457845 Is Effective In Treating Pain, Is Safe And Tolerable In Patients With Osteoarthritis Of The Knee

NCT ID: NCT00981357

Last Updated: 2017-09-19

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

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-05-31

Brief Summary

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Inactivation of the FAAH (Fatty Acid Amide Hydrolase) enzyme has been shown to relieve pain and inflammation in animal studies. PF-04457845 has been shown to inactivate the FAAH enzyme in animals and healthy human volunteers. The purpose of this study is to evaluate whether PF-04457845 can inactivate the FAAH enzyme in patients experiencing pain due to OA and whether this results in these patients experiencing less pain.

Detailed Description

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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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PF-04457845 followed by placebo

Group Type EXPERIMENTAL

PF-04457845

Intervention Type DRUG

PF-04457845 4 mg tablet once daily / matched placebo

Placebo followed by PF-04457845

Group Type EXPERIMENTAL

PF-04457845

Intervention Type DRUG

PF-04457845 4 mg tablet once daily / matched placebo

Naproxen followed by placebo

Group Type ACTIVE_COMPARATOR

Naproxen

Intervention Type DRUG

Naproxen 500 mg tablet twice daily / matched placebo

Placebo followed by Naproxen

Group Type ACTIVE_COMPARATOR

Naproxen

Intervention Type DRUG

Naproxen 500 mg tablet twice daily / matched placebo

Interventions

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PF-04457845

PF-04457845 4 mg tablet once daily / matched placebo

Intervention Type DRUG

PF-04457845

PF-04457845 4 mg tablet once daily / matched placebo

Intervention Type DRUG

Naproxen

Naproxen 500 mg tablet twice daily / matched placebo

Intervention Type DRUG

Naproxen

Naproxen 500 mg tablet twice daily / matched placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects must have a diagnosis of Osteoarthritis (OA) of the knee confirmed by X-ray
* Subjects must be willing and able to stop all current pain therapy for the duration of study. (Limited and specific pain therapy will be available throughout the study)
* Subjects can be male or female between the ages of 18 and 75 years inclusive, but female subjects must not be able become pregnant

Exclusion Criteria

* Subjects must not have any condition or medical history that might interfere with their ability to complete the study 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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Arthritis & Rheumatic Care Center

Miami, Florida, United States

Site Status

Miami Research Associates

Miami, Florida, United States

Site Status

Vince and Associates Clinical Research

Overland Park, Kansas, United States

Site Status

Vince and Associates Clinical Research

Overland Park, Kansas, United States

Site Status

CEDRA Clinical Research, LLC

San Antonio, Texas, United States

Site Status

Diex Research Inc.

Sherbrooke, Quebec, Canada

Site Status

Centrum for klinisk provning

Gothenburg, , 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=B0541004&StudyName=A%20Study%20To%20Investigate%20Whether%20PF-04457845%20Is%20Effective%20In%20Treating%20Pain%2C%20Is%20Safe%20And%20Tolerable%20In%20Patients%20With%20Osteoarthritis%20Of%20T

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

Other Identifiers

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2009-014734-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B0541004

Identifier Type: -

Identifier Source: org_study_id