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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.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: Placebo
Drug: Acurox 5/30 mg
Drug: Acurox 7.5/30
Enrollment 405
Recruitment Details 405 post-bunionectomy patients
Pre-assignment Details Subjects dose immediately post-surgery when pain intensity was equal to or greater than moderate. Dosed and followed for 48 hours.
Arm/Group Title Placebo Acurox 5/30mg Acurox 7.5/30mg
Hide Arm/Group Description 2 Tablets Every 6 Hours 2x oxycodone 5mg/naicin 30mg every 6 hours 2x oxycodone 7.5mg/naicin 30mg every 6 hours
Period Title: Overall Study
Started 136 135 134
Completed 119 124 116
Not Completed 17 11 18
Arm/Group Title Placebo Acurox 5/30 Acurox 7.5/30 Total
Hide Arm/Group Description 2x Placebo Tablets 2x oxycodone/niacin 5/30mg tablets 2x oxycodone/niacin 7.5/30mg tablets Total of all reporting groups
Overall Number of Baseline Participants 136 135 134 405
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 135 participants 134 participants 405 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
117
  86.0%
117
  86.7%
116
  86.6%
350
  86.4%
>=65 years
19
  14.0%
18
  13.3%
18
  13.4%
55
  13.6%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 136 participants 135 participants 134 participants 405 participants
42.0
(18 to 71)
41.8
(18 to 76)
41.6
(18 to 77)
41.8
(18 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 135 participants 134 participants 405 participants
Female
114
  83.8%
125
  92.6%
120
  89.6%
359
  88.6%
Male
22
  16.2%
10
   7.4%
14
  10.4%
46
  11.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 136 participants 135 participants 134 participants 405 participants
136 135 134 405
1.Primary Outcome
Title SPID48
Hide Description

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).

Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Acurox 5/30 Acurox 7.5/30
Hide Arm/Group Description:
Placebo Tablet
oxycodone 5mg/niacin 30mg
oxycodone 7.5mg/niacin 30mg
Overall Number of Participants Analyzed 119 124 116
Mean (Standard Deviation)
Unit of Measure: score on a scale
604.48  (1124.857) 998.46  (1102.164) 1224.97  (1128.569)
Time Frame 48 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Acurox 5/30 Acurox 7.5/30
Hide Arm/Group Description Placebo Pill oxycodone 5mg/niacin 30mg oxycodone 7.5mg/niacin 30mg
All-Cause Mortality
Placebo Acurox 5/30 Acurox 7.5/30
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/136 (0.00%)      0/135 (0.00%)      0/134 (0.00%)    
Hide Serious Adverse Events
Placebo Acurox 5/30 Acurox 7.5/30
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/136 (0.00%)      0/135 (0.00%)      0/134 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Acurox 5/30 Acurox 7.5/30
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   51/136 (37.50%)      104/135 (77.04%)      117/134 (87.31%)    
Gastrointestinal disorders       
Nausea  1  23/136 (16.91%)  23 68/135 (50.37%)  68 83/134 (61.94%)  83
Vomiting  1  14/136 (10.29%)  14 46/135 (34.07%)  46 67/134 (50.00%)  67
Nervous system disorders       
Dizziness  1  6/136 (4.41%)  6 22/135 (16.30%)  22 32/134 (23.88%)  32
Headache  1  3/136 (2.21%)  3 13/135 (9.63%)  13 11/134 (8.21%)  11
Somnolence  1  2/136 (1.47%)  2 8/135 (5.93%)  8 6/134 (4.48%)  6
Skin and subcutaneous tissue disorders       
Pruritis  1  1/136 (0.74%)  1 17/135 (12.59%)  17 13/134 (9.70%)  13
Vascular disorders       
Flushing  1  2/136 (1.47%)  2 22/135 (16.30%)  22 15/134 (11.19%)  15
1
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ron Spivey
Organization: Acura Pharma
Phone: 847-705-7709
EMail: rspivey@acurapharm.com
Layout table for additonal information
Responsible Party: Acura Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00654069    
Other Study ID Numbers: AP-ADF-105
First Submitted: April 2, 2008
First Posted: April 7, 2008
Results First Submitted: June 27, 2018
Results First Posted: August 22, 2018
Last Update Posted: August 22, 2018