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

NCT00654069 | Completed Phase 3 Results

• 1 other identifier: AP-ADF-105
• Study Type: interventional
• Target: 405
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain

Keywords

Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Tablet

Drug: Placebo

Acurox 5/30mg

ACTIVE COMPARATOR

Oxycodone HCl 5mg/Niacin 30mg tablet

Drug: Acurox 5/30 mg

Acurox 7.5/30

PLACEBO COMPARATOR

Oxycodone HCl 7.5mg/Niacin 30mg tablet

Drug: Acurox 7.5/30

Interventions

Placebo DRUG

2 tablets every 6 hours for 48 hours

Also known as: Placebo Tablet

Placebo

Acurox 5/30 mg DRUG

2 tablets every 6 hours for 48 hours

Also known as: oxycodone/niacin 5/30mg

Acurox 5/30mg

Acurox 7.5/30 DRUG

2 tablets every 6 hours for 48 hours

Also known as: oxycodone/niacin 7.5/30mg

Acurox 7.5/30

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acura Pharmaceuticals Inc.: lead

Related Publications (1)

• 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.

  PMID: 21231862 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Oxycodone; Niacin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Nicotinic Acids; Acids, Heterocyclic; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Ron Spivey
• Organization: Acura Pharma

rspivey@acurapharm.com

847-705-7709

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2008
• First Posted: April 7, 2008
• Study Start: September 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: March 1, 2008
• Last Updated: August 22, 2018
• Results First Posted: August 22, 2018

Record last verified: 2008-04