Conditions: Pain
Keywords: Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 405
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Tablet arm 2: Oxycodone HCl 5mg/Niacin 30mg tablet arm 3: Oxycodone HCl 7.5mg/Niacin 30mg tablet

Interventions: intervention 1: Placebo intervention 2: Acurox 5/30 mg intervention 3: Acurox 7.5/30
Intervention descriptions: intervention 1: 2 tablets every 6 hours for 48 hours intervention 2: 2 tablets every 6 hours for 48 hours intervention 3: 2 tablets every 6 hours for 48 hours

Protocol document: