Pain Clinical Trial
Official title:
A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Repeat-dose Study of the Safety and Efficacy of Acuroc Tablets Following Bunionectomy Surgery in Adult Patients
The purpose of this study is to determine whether oxycodone HCl and niacin are effective in the treatment of pain following bunionectomy surgery.
This was a Phase III, randomized, double blind, placebo controlled, multicenter, repeat dose
study of the safety and efficacy of 2 dose levels of Acurox™ Tablets versus placebo for the
treatment of moderate to severe postoperative pain following bunionectomy surgery.
Patients underwent a primary unilateral first metatarsal bunionectomy with or without
ipsilateral hammer toe repair during standardized local anesthesia with intravenous (IV)
sedation. Eligible patients who reported moderate or severe pain within 6 hours after surgery
entered the Treatment Phase and were randomized to 1 of 3 double blind treatments: placebo
tablets or 1 of 2 dose levels of Acurox™ Tablets (ocyxcodone HCl/niacin). The Treatment Phase
continued with study medication every 6 hours (irrespective of rescue medication use) for 48
hours (8 doses of study medication). Toradol (ketorolac tromethamine) was available as a
rescue medication upon request.
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