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

Condition(s) targeted: Pain

Intervention: Oxycodone HCl/Niacin Tablets 5/30 mg (Drug); Oxycodone HCl/Niacin 7.5/30 mg (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Acura Pharmaceuticals Inc.

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

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Repeat-Dose Study of the Safety and Efficacy of OxyADF (Oxycodone HCl and Niacin) Tablets for the Treatment of Acute, Moderate to Severe Postoperative Pain Following Bunionectomy Surgery in Adult Patients

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Reduction in pain intensity

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Starting date: September 2007
Last updated: April 2, 2008