A Study of Pain Relief in Osteoarthritis

• Pain intensity difference (PID) from baseline to each scheduled evaluation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Western Ontario and McMaster (WOMAC) Osteoarthritis Index total score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• SF-36v2 Health Status Survey [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

• Pain intensity difference from baseline to each scheduled evaluation
• Proportion of treatment responders
• Global assessments of study drug and arthritis status
• Western Ontario and McMaster (WOMAC) Osteoarthritis Index total score and 3 subscales
• SF-36v2 Health Status Survey

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.

• Drug: hydrocodone / acetaminophen extended release
  2 tablets twice daily
  Other Name: ABT-712
• Drug: Placebo
  2 tablets twice daily
  Other Name: Placebo

• Experimental: hydrocodone/acetaminophen extended release
  Intervention: Drug: hydrocodone / acetaminophen extended release
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

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