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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00654069
Recruitment Status : Completed
First Posted : April 7, 2008
Results First Posted : August 22, 2018
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Acura Pharmaceuticals Inc.

Tracking Information
First Submitted Date  ICMJE April 2, 2008
First Posted Date  ICMJE April 7, 2008
Results First Submitted Date  ICMJE June 27, 2018
Results First Posted Date  ICMJE August 22, 2018
Last Update Posted Date August 22, 2018
Study Start Date  ICMJE September 2007
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2018)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: April 2, 2008)
Reduction in pain intensity [ Time Frame: 48 hours ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety/Efficacy Study of Oxycodone HCl/Niacin to Treat Pain After Bunionectomy
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Placebo
    2 tablets every 6 hours for 48 hours
    Other Name: Placebo Tablet
  • Drug: Acurox 5/30 mg
    2 tablets every 6 hours for 48 hours
    Other Name: oxycodone/niacin 5/30mg
  • Drug: Acurox 7.5/30
    2 tablets every 6 hours for 48 hours
    Other Name: oxycodone/niacin 7.5/30mg
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Tablet
    Intervention: Drug: Placebo
  • Active Comparator: Acurox 5/30mg
    Oxycodone HCl 5mg/Niacin 30mg tablet
    Intervention: Drug: Acurox 5/30 mg
  • Placebo Comparator: Acurox 7.5/30
    Oxycodone HCl 7.5mg/Niacin 30mg tablet
    Intervention: Drug: Acurox 7.5/30
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2008)
405
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00654069
Other Study ID Numbers  ICMJE AP-ADF-105
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Acura Pharmaceuticals Inc.
Original Responsible Party Ron J. Spivey, PhD/Sr. V.P. & Chief Scientific Officer, Acura Pharmaceuticals, Inc.
Current Study Sponsor  ICMJE Acura Pharmaceuticals Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Acura Pharmaceuticals Inc.
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP