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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pain

Intervention / Treatment
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* Drug: Placebo
* Drug: Acurox 5/30 mg
* Drug: Acurox 7.5/30


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain