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

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ClinicalTrials.gov Identifier: NCT00654069
Recruitment Status : Completed
First Posted : April 7, 2008
Results First Posted : August 22, 2018
Last Update Posted : August 22, 2018
Information provided by (Responsible Party):
Acura Pharmaceuticals Inc.

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.

Condition or disease Intervention/treatment Phase
Pain Drug: Placebo Drug: Acurox 5/30 mg Drug: Acurox 7.5/30 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 405 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo
Drug: Placebo
2 tablets every 6 hours for 48 hours
Other Name: 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 Name: 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 Name: oxycodone/niacin 7.5/30mg

Primary Outcome Measures :
  1. SPID48 [ Time Frame: 48 hours ]

    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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Acura Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00654069    
Other Study ID Numbers: AP-ADF-105
First Posted: April 7, 2008    Key Record Dates
Results First Posted: August 22, 2018
Last Update Posted: August 22, 2018
Last Verified: April 2008
Keywords provided by Acura Pharmaceuticals Inc.:
Additional relevant MeSH terms:
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Nicotinic Acids
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex