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

Acura Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: Placebo; Drug: Acurox 5/30 mg; Drug: Acurox 7.5/30

Study type: Interventional

Funder types: Industry

Identifiers

NCT00654069

AP-ADF-105

Details and patient eligibility

About

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

Full 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.

Enrollment: 405 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is male or female at least 18 years of age
• For women of child-bearing potential: woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
• Patient is scheduled to have a bunionectomy
• Patient must be willing to stay at the study site for at least 48 hours from the initial dose of study medication post-surgery

Exclusion criteria

• Patient has a current disease or history of a disease that will impact the study or the patient's well-being
• Patient has used or intends to use any of the medications that are prohibited by the protocol
• Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen
• Patient is hypersensitive to any of the medications to be used in the study
• Patient has taken another investigational drug within 30 days prior to Screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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405 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Tablet

Treatment:

Drug: Placebo

Acurox 5/30mg

Active Comparator group

Description:

Oxycodone HCl 5mg/Niacin 30mg tablet

Treatment:

Drug: Acurox 5/30 mg

Acurox 7.5/30

Placebo Comparator group

Description:

Oxycodone HCl 7.5mg/Niacin 30mg tablet

Treatment:

Drug: Acurox 7.5/30