The purpose of this study is to compare the safety and pain-relieving ability of Vicodin CR
to placebo in subjects with osteoarthritis (OA) of the hip or knee.
Inclusion Criteria:
- Males and females ages 21 to 80
- If female, must be of non-child bearing potential or practicing birth control
- Has osteoarthritis of the hip or knee
- Requires therapeutic doses of medication for osteoarthritis pain
- Has sufficient pain to justify the use of around-the-clock opioids
Exclusion Criteria:
- Is associated with any currently ongoing research study, or has previously
participated in a Vicodin CR study
- Is allergic to or has had a serious reaction to hydrocodone, other opioids, or
acetaminophen
- Cannot discontinue pain medications, even for the short time prior to the study start
- Has any clinically significant illness or recent injury, or has any significant
laboratory abnormality, or has recently had major surgery
- Has a history of gastric bypass surgery or preexisting severe gastrointestinal
narrowing, or history of diseases that may narrow the gastrointestinal tract
- Has a history of malnutrition or starvation
- Has a history of drug (licit or illicit) or alcohol abuse or addiction, or consumes
more than 4 alcoholic drinks per day
- Has a history of a major depressive episode within the past 2 years, or requires
treatment with certain drugs for depression, or has a history of major psychiatric
disorder
- Pregnant or breastfeeding females
- Is incapacitated, bedridden or confined to a wheelchair
- Has initiated any new therapy or medication for OA within 1 month of screening
- Has had surgery, certain types of procedures, or received certain medications for
osteoarthritis within a specified time frame
- Has other conditions that may cause pain, such as rheumatoid arthritis or gout
Birmingham, Alabama 35244, United States
Mobile, Alabama 36608, United States
Birmingham, Alabama 35235, United States
Phoenix, Arizona 85012, United States
Sierra Vista, Arizona 85635, United States
Tucson, Arizona 85741, United States
Tucson, Arizona 85712, United States
Tempe, Arizona 85282, United States
Phoenix, Arizona 85020, United States
Pheonix, Arizona 85023, United States
Pheonix, Arizona 85014, United States
San Diego, California 92108, United States
Fair Oaks, California 95628, United States
Buena Park, California 90620, United States
Los Angeles, California 90095-1670, United States
Anaheim, California 92801, United States
Wheatridge, Colorado 80033, United States
Littleton, Colorado 80120, United States
Pembroke Pines, Florida 33024, United States
Plantation, Florida 33324, United States
Clearwater, Florida 33761, United States
Ocala, Florida 34474, United States
Miami, Florida 33156, United States
Port Orange, Florida 32127, United States
Ocala, Florida 34471, United States
DeLand, Florida 32720, United States
West Palm Beach, Florida 33409, United States
Jupiter, Florida 33458-7200, United States
Longwood, Florida 32779, United States
Ormond Beach, Florida 32174, United States
St. Petersburg, Florida 33703, United States
Oldsmar, Florida 34677, United States
Largo, Florida 33770, United States
Brandon, Florida 33511, United States
Marietta, Georgia 30066, United States
Meridian, Idaho 83642, United States
Chicago, Illinois 60611, United States
Evansville, Indiana 47714, United States
Newburgh, Indiana 47630, United States
Louisville, Kentucky 40213, United States
New Orleans, Louisiana 70115, United States
Pasadena, Maryland 21122, United States
Owings Mills, Maryland 21117, United States
Fall River, Massachusetts 02720, United States
Wellesley Hills, Massachusetts 02481, United States
West Yarmouth, Massachusetts 02673, United States
Brockton, Massachusetts 02301, United States
Kalamazoo, Michigan 49009, United States
Biloxi, Mississippi 39531, United States
St. Louis, Missouri 63141, United States
Florissant, Missouri 63031, United States
Omaha, Nebraska 68134, United States
Mamaroneck, New York 10543, United States
Roslyn, New York 11576, United States
New York, New York 10022, United States
Monroe, North Carolina 28112, United States
Winston-Salem, North Carolina 27103, United States
Columbus, Ohio 43235, United States
Cleveland, Ohio 44122, United States
Cincinnati, Ohio 45236, United States
Cincinnati, Ohio 45242, United States
Zanesville, Ohio 43701, United States
Centerville, Ohio 45459, United States
Oklahoma City, Oklahoma 73139, United States
Portland, Oregon 97239, United States
Eugene, Oregon 97404, United States
Portland, Oregon 97201, United States
West Reading, Pennsylvania 19611, United States
Mechanicsburg, Pennsylvania 17055, United States
Duncansville, Pennsylvania 16635, United States
Cranston, Rhode Island 02920, United States
Greenville, South Carolina 29601, United States
Greer, South Carolina 29651, United States
Milan, Tennessee 38358, United States
San Antonio, Texas 78209, United States
Austin, Texas 78705, United States
San Antonio, Texas 78229, United States
Richardson, Texas 75080, United States
Salt Lake City, Utah 84102, United States
Virginia Beach, Virginia 23454, United States
Virginia Beach, Virginia 23451, United States
Virginia Beach, Virginia 23455, United States
Spokane, Washington 99204, United States
