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

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acura Pharmaceuticals Inc.
• Treatments: Niacin; Niacinamide; Nicotinic Acids; Oxycodone

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