Pain Clinical Trial
Official title:
A Randomized, Multicenter, Single-Blind Study Comparing Hydrocodone/Acetaminophen Extended Release 10/650, Morphine Extended Release, and Acetaminophen to Placebo in Subjects With Acute Pain Following Bunionectomy
The primary purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen extended release compared to placebo in moderate to severe pain following primary unilateral first metatarsal bunionectomy.
The bunionectomy was performed under regional anesthesia and propofol sedation.
Perioperative anesthesia was standardized for all participants. Upon completion of surgery,
designated study personnel ensured continued eligibility per the selection criteria of the
protocol.
After an appropriate period of time following bunionectomy, participants who had a pain
intensity score of ≥ 40 mm on a 100 mm visual analog scale (VAS) and moderate or severe pain
intensity per the categorical pain intensity scale were eligible for randomization, in equal
numbers, into 1 of 5 treatment arms. In order to maintain the single-blind nature of the
study, all participants were dosed with study drug (active and/or placebo) every 6 hours.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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