Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee

NCT ID: NCT00504127

Last Updated: 2011-06-17

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

PHASE3

Total Enrollment

1020 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Brief Summary

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To study of efficacy and safety of Naproxcinod vs. Naproxen and Placebo in the indication of signs and symptoms of osteoarthritis

Detailed Description

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This is a 53 week study consisting in a 26 week randomized, double-blind, parallel group, multicenter study comparing efficacy and safety of Naproxcinod, Placebo and Naproxen. The first 26 weeks will be followed by a naproxen-controlled treatment period up to 52 weeks and a 1-week post-treatment safety follow-up.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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naproxcinod 375 mg bid

Group Type EXPERIMENTAL

Naproxcinod 375 mg bid

Intervention Type DRUG

Naproxcinod 375 mg bid

naproxcinod 750 mg bid

Group Type EXPERIMENTAL

Naproxcinod 750 mg bid

Intervention Type DRUG

Naproxcinod 750 mg bid

naproxen 500 mg bid

Group Type ACTIVE_COMPARATOR

Naproxen 500 mg bid

Intervention Type DRUG

Naproxen 500 mg bid

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo

Interventions

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Naproxcinod 375 mg bid

Naproxcinod 375 mg bid

Intervention Type DRUG

Naproxcinod 750 mg bid

Naproxcinod 750 mg bid

Intervention Type DRUG

Naproxen 500 mg bid

Naproxen 500 mg bid

Intervention Type DRUG

placebo

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men and Woman (40 or older) with a diagnosis of primary OA of the knee.
* Must be a current chronic user of NSAIDS or acetaminophen
* Must discontinue all analgesic therapy at Screening

Exclusion Criteria

* Uncontrolled Hypertension or Diabetes
* Hepatic or Renal Impairment
* Current or expected use of anti-coagulant
* Clinical relevant abnormal ECG
* A history of alcohol or drug abuse
* Candidates for imminent joint replacement
* Participation within 30 days prior to screening in another investigational study
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NicOx

INDUSTRY

Sponsor Role lead

Responsible Party

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nicox

Locations

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Chandler, Arizona, United States

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Tempe, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Anaheim, California, United States

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Encino, California, United States

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Foothill Ranch, California, United States

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Orange, California, United States

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Rancho Mirage, California, United States

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Riverside, California, United States

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Denver, Colorado, United States

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Waterbury, Connecticut, United States

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Boca Raton, Florida, United States

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Brooksville, Florida, United States

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DeLand, Florida, United States

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Jacksonville, Florida, United States

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Largo, Florida, United States

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Ocala, Florida, United States

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Pinellas Park, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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Athens, Georgia, United States

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Atlanta, Georgia, United States

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Marietta, Georgia, United States

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Chicago, Illinois, United States

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Rockford, Illinois, United States

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Prairie Village, Kansas, United States

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Wichita, Kansas, United States

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Erlanger, Kentucky, United States

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Louisville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Owings Mills, Maryland, United States

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Wellesley Hills, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Brooklyn Center, Minnesota, United States

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Edina, Minnesota, United States

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Florissant, Missouri, United States

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St Louis, Missouri, United States

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Rochester, New York, United States

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Asheville, North Carolina, United States

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Charlotte, North Carolina, United States

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Concord, North Carolina, United States

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Raleigh, North Carolina, United States

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Salisbury, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Beachwood, Ohio, United States

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Columbus, Ohio, United States

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Marion, Ohio, United States

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Clinton, Oklahoma, United States

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Altoona, Pennsylvania, United States

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Bensalem, Pennsylvania, United States

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Duncansville, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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West Reading, Pennsylvania, United States

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Anderson, South Carolina, United States

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Clinton, South Carolina, United States

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Goose Creek, South Carolina, United States

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Greer, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Cordova, Tennessee, United States

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Jackson, Tennessee, United States

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Kingsport, Tennessee, United States

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Memphis, Tennessee, United States

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Dallas, Texas, United States

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Garland, Texas, United States

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Houston, Texas, United States

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Nederland, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Norfolk, Virginia, United States

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Roanoke, Virginia, United States

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Virginia Beach, Virginia, United States

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Lakewood, Washington, United States

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Countries

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United States

Other Identifiers

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HCT 3012-X-302

Identifier Type: -

Identifier Source: org_study_id

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