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

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Repeat-dose Study of the Safety and Efficacy of Acuroc Tablets Following Bunionectomy Surgery in Adult Patients

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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Placebo; Drug: Acurox 5/30 mg; Drug: Acurox 7.5/30

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.

• Study Type: Interventional
• Enrollment (Actual): 405
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Tablet	Drug: Placebo; 2 tablets every 6 hours for 48 hours; Other Names: Placebo Tablet
Active Comparator: Acurox 5/30mg; Oxycodone HCl 5mg/Niacin 30mg tablet	Drug: Acurox 5/30 mg; 2 tablets every 6 hours for 48 hours; Other Names: oxycodone/niacin 5/30mg
Placebo Comparator: Acurox 7.5/30; Oxycodone HCl 7.5mg/Niacin 30mg tablet	Drug: Acurox 7.5/30; 2 tablets every 6 hours for 48 hours; Other Names: oxycodone/niacin 7.5/30mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SPID48	Time weighted Sum of Pain Intensity Differences over the first 48 hours (SPID48) is the sum of the Pain Intensity Difference (PID) scores observed at 0.5 , 1, 2, 3, 4, 5, 6, 12, 18, 24, 30, 36, 42, and 48 hours post-dose. Pain Intensity scores at each timepoint are based on a 100 mm visual analog scale (VAS) from 0 = no pain to 100 = worst pain imaginable. PID is calculated as the timepoint score less the baseline pre-dose score (i.e. PID.5 = PI.5 - PI0). SPID48 = the PID for each timepoint multiplied by a time weighting factor; which is the difference (in hours) between the PID observation and prior observation. SPID48 = PID.5*.5 + PID1*.5 + PID2*1 + PID3*1 + PID4*1 + PID6*2 +PID12*6 + PID18*6 +PID24*6 + PID30*6 + PID36*6 + PID42*6 + PID48*6. The maximum SPID48 value is 4,800 (assumes PI0 of 100 and a PI of 0 at all subsequent timepoints) with a midpoint SPID48 of 2,400 (PI0=50 and PI of 0 at all subsequent readings).	48 hours

Collaborators and Investigators

• Sponsor: Acura Pharmaceuticals Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: April 2, 2008
• First Submitted That Met QC Criteria: April 2, 2008
• First Posted (Estimate): April 7, 2008

Study Record Updates

• Last Update Posted (Actual): August 22, 2018
• Last Update Submitted That Met QC Criteria: August 21, 2018
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Keywords: Pain
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Antimetabolites; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Analgesics, Opioid; Narcotics; Vitamins; Vitamin B Complex; Nicotinic Acids; Oxycodone; Niacinamide; Niacin
• Other Study ID Numbers: AP-ADF-105