NCT00654069

Safety/Efficacy Study of Oxycodone HCl/Niacin to Treat Pain After Bunionectomy

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 405 (actual)
• Sponsor: Acura Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether oxycodone HCl and niacin are effective in the treatment of pain following bunionectomy surgery.

Detailed description

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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Placebo	2 tablets every 6 hours for 48 hours
DRUG	Acurox 5/30 mg	2 tablets every 6 hours for 48 hours
DRUG	Acurox 7.5/30	2 tablets every 6 hours for 48 hours

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-02-01
• Completion: 2008-03-01
• First posted: 2008-04-07
• Last updated: 2018-08-22
• Results posted: 2018-08-22