Pain
Conditions
Keywords
Acute pain following bunionectomy surgery
Brief summary
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of Extended-Release Hydrocodone/Acetaminophen compared to placebo over a 48 hour dosing period in patients who have had bunionectomy surgery and to assess the safety of the drug for 7 days after patients are discharged from the hospital.
Interventions
1 tablet q 12 hours
2 tablets q 12 hours
DRUGPlacebo
2 tablets q 12 hours
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Males and females ages 18 to 65 * Subject is scheduled to undergo primary, unilateral first metatarsal bunionectomy surgery * Meet specific pain intensity criteria on the morning after surgery * Willing to be confined for 4 days following surgery * If female, must be of non-child bearing potential or practicing birth control
Exclusion criteria
* Is allergic to or has a serious reaction to hydrocodone, acetaminophen, lidocaine, propofol, morphine sulfate, oxycodone, and/or similar drugs * Is allergic to or has a serious reaction to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) * Has a history of certain gastrointestinal diseases that may narrow or slow down the gastrointestinal tract * Has specific active or uncontrolled seizure disorders * Has been diagnosed with certain cancers within the past 5 years * Has a history of certain psychiatric disorders or requires treatment with certain drugs for depression * Has specific clinically significant illnesses or laboratory abnormalities * Has received corticosteroid treatment or any investigational drug within a specific timeframe
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-interval weighted sum of pain intensity difference (SPID) using the visual analog scale (VAS) for the 0 to 12 hour interval following study drug administration. | 12 hours | Sum of pain intensity difference using a 100 mm Visual Analog Scale (VAS) |
Secondary
| Measure | Time frame |
|---|---|
| Time-interval weighted sum of pain relief and pain intensity difference (SPRID) | 12 hours |
| Perceptible pain relief | 12 hours |
| Time-interval weighted sum of pain relief (TOTPAR) | 12 hours |
| Pain relief (PR) | 12 hours |
| Pain intensity (PI) | 12 hours |
| Meaningful pain relief | 12 hours |
Countries
United States
Outcome results
None listed