A 2 Week Blinded Study For Pain Due To Arthritis Of The Knee

NCT ID: NCT00483977

Last Updated: 2011-04-29

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

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-12-31

Brief Summary

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The primary aim is to assess if PF-00592379 is able to reduce pain in patients with osteoarthritis of the knee.

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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Oxycodone

Group Type ACTIVE_COMPARATOR

Oxycodone

Intervention Type DRUG

Oxycodone: oral controlled release, 20 mg, twice a day for 2 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo: oral for 2 weeks.

PF-00592379

Group Type EXPERIMENTAL

PF-000592379

Intervention Type DRUG

PF-00592379: oral, 30 mg, once a day for 2 weeks

Interventions

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Oxycodone

Oxycodone: oral controlled release, 20 mg, twice a day for 2 weeks

Intervention Type DRUG

Placebo

Placebo: oral for 2 weeks.

Intervention Type DRUG

PF-000592379

PF-00592379: oral, 30 mg, once a day for 2 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female of any race
* Between the ages of 18 and 75 years
* Knee Pain due to osteoarthritis

Exclusion Criteria

* Pregnant
* Participation in a clinical trial for an investigational drug and/or agent within 30 days prior to baseline
* History of malignancy, convulsions, chronic infections, arthroscopy of the worst knee within the past year
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

Mobile, Alabama, United States

Site Status

Pfizer Investigational Site

Tucson, Arizona, United States

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Pfizer Investigational Site

Carmichael, California, United States

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Fair Oaks, California, United States

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Orangevale, California, United States

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Roseville, California, United States

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Sacramento, California, United States

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Boca Raton, Florida, United States

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DeLand, Florida, United States

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Hollywood, Florida, United States

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Longwood, Florida, United States

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Miami, Florida, United States

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Louisville, Kentucky, United States

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Madisonville, Kentucky, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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New York, New York, United States

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Durham, North Carolina, United States

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Cincinnati, Ohio, United States

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Pfizer Investigational Site

Cincinnati, Ohio, United States

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Pfizer Investigational Site

Richmond, Virginia, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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A7771010

Identifier Type: -

Identifier Source: org_study_id