Osteoarthritis
Conditions
Keywords
Osteoarthritis of the hip or knee
Brief summary
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.
Interventions
DRUGhydrocodone / acetaminophen extended release
2 tablets twice daily
DRUGPlacebo
2 tablets twice daily
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | 12 weeks | Arthritis Pain Intensity measured by a 100mm Visual Analog Scale (VAS) |
Secondary
| Measure | Time frame |
|---|---|
| Pain intensity difference (PID) from baseline to each scheduled evaluation | 12 weeks |
| Western Ontario and McMaster (WOMAC) Osteoarthritis Index total score | 12 weeks |
| SF-36v2 Health Status Survey | 12 weeks |
Countries
United States
Outcome results
None listed