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

NCT ID: NCT00654069

Last Updated: 2018-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 405 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-03-31

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Tablet

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

2 tablets every 6 hours for 48 hours

Acurox 5/30mg

Oxycodone HCl 5mg/Niacin 30mg tablet

Group Type: ACTIVE_COMPARATOR

Acurox 5/30 mg

Intervention Type: DRUG

2 tablets every 6 hours for 48 hours

Acurox 7.5/30

Oxycodone HCl 7.5mg/Niacin 30mg tablet

Group Type: PLACEBO_COMPARATOR

Acurox 7.5/30

Intervention Type: DRUG

2 tablets every 6 hours for 48 hours

Interventions

Placebo

2 tablets every 6 hours for 48 hours

Intervention Type: DRUG

Acurox 5/30 mg

2 tablets every 6 hours for 48 hours

Intervention Type: DRUG

Acurox 7.5/30

2 tablets every 6 hours for 48 hours

Intervention Type: DRUG

Other Intervention Names

Placebo Tablet; oxycodone/niacin 5/30mg; oxycodone/niacin 7.5/30mg

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acura Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Daniels SE, Spivey RJ, Singla S, Golf M, Clark FJ. Efficacy and safety of oxycodone HCl/niacin tablets for the treatment of moderate-to-severe postoperative pain following bunionectomy surgery. Curr Med Res Opin. 2011 Mar;27(3):593-603. doi: 10.1185/03007995.2010.548291. Epub 2011 Jan 13.

Reference Type: DERIVED

PMID: 21231862 (View on PubMed)

Other Identifiers

AP-ADF-105

Identifier Type: -

Identifier Source: org_study_id