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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
Site Ref # / Investigator 2589
Austin, Texas, United States
Site Ref # / Investigator 2587
Houston, Texas, United States
Site Ref # / Investigator 2586
San Antonio, Texas, United States
Site Ref # / Investigator 2588
San Marcos, Texas, United States
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.
Sum of pain intensity difference using a 100 mm Visual Analog Scale (VAS)
Time frame: 12 hours
Time-interval weighted sum of pain relief (TOTPAR)
Time frame: 12 hours
Time-interval weighted sum of pain relief and pain intensity difference (SPRID)
Time frame: 12 hours
Perceptible pain relief
Time frame: 12 hours
Meaningful pain relief
Time frame: 12 hours
Pain relief (PR)
Time frame: 12 hours
Pain intensity (PI)
Time frame: 12 hours
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Site Ref # / Investigator 2585
Salt Lake City, Utah, United States