MedDataX Logo

Trial Outcomes & Findings for Safety/Efficacy Study of Oxycodone HCl/Niacin to Treat Pain After Bunionectomy (NCT NCT00654069)

NCT ID: NCT00654069

Last Updated: 2018-08-22

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

405 participants

Primary outcome timeframe

48 hours

Results posted on

2018-08-22

Participant Flow

405 post-bunionectomy patients

Subjects dose immediately post-surgery when pain intensity was equal to or greater than moderate. Dosed and followed for 48 hours.

Participant milestones

Participant milestones
Measure
Placebo
2 Tablets Every 6 Hours
Acurox 5/30mg
2x oxycodone 5mg/naicin 30mg every 6 hours
Acurox 7.5/30mg
2x oxycodone 7.5mg/naicin 30mg every 6 hours
Overall Study
STARTED
136
135
134
Overall Study
COMPLETED
119
124
116
Overall Study
NOT COMPLETED
17
11
18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo
n=136 Participants
2x Placebo Tablets
Acurox 5/30
n=135 Participants
2x oxycodone/niacin 5/30mg tablets
Acurox 7.5/30
n=134 Participants
2x oxycodone/niacin 7.5/30mg tablets
Total
n=405 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
117 Participants
n=5 Participants
117 Participants
n=7 Participants
116 Participants
n=5 Participants
350 Participants
n=4 Participants
Age, Categorical
>=65 years
19 Participants
n=5 Participants
18 Participants
n=7 Participants
18 Participants
n=5 Participants
55 Participants
n=4 Participants
Age, Continuous
42.0 years
n=5 Participants
41.8 years
n=7 Participants
41.6 years
n=5 Participants
41.8 years
n=4 Participants
Sex: Female, Male
Female
114 Participants
n=5 Participants
125 Participants
n=7 Participants
120 Participants
n=5 Participants
359 Participants
n=4 Participants
Sex: Female, Male
Male
22 Participants
n=5 Participants
10 Participants
n=7 Participants
14 Participants
n=5 Participants
46 Participants
n=4 Participants
Region of Enrollment
United States
136 participants
n=5 Participants
135 participants
n=7 Participants
134 participants
n=5 Participants
405 participants
n=4 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Placebo
n=119 Participants
Placebo Tablet
Acurox 5/30
n=124 Participants
oxycodone 5mg/niacin 30mg
Acurox 7.5/30
n=116 Participants
oxycodone 7.5mg/niacin 30mg
SPID48
604.48 score on a scale
Standard Deviation 1124.857
998.46 score on a scale
Standard Deviation 1102.164
1224.97 score on a scale
Standard Deviation 1128.569

Adverse Events

Placebo

Serious events: 0 serious events
Other events: 51 other events
Deaths: 0 deaths

Acurox 5/30

Serious events: 0 serious events
Other events: 104 other events
Deaths: 0 deaths

Acurox 7.5/30

Serious events: 0 serious events
Other events: 117 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Placebo
n=136 participants at risk
Placebo Pill
Acurox 5/30
n=135 participants at risk
oxycodone 5mg/niacin 30mg
Acurox 7.5/30
n=134 participants at risk
oxycodone 7.5mg/niacin 30mg
Gastrointestinal disorders
Nausea
16.9%
23/136 • Number of events 23 • 48 hours
50.4%
68/135 • Number of events 68 • 48 hours
61.9%
83/134 • Number of events 83 • 48 hours
Gastrointestinal disorders
Vomiting
10.3%
14/136 • Number of events 14 • 48 hours
34.1%
46/135 • Number of events 46 • 48 hours
50.0%
67/134 • Number of events 67 • 48 hours
Nervous system disorders
Dizziness
4.4%
6/136 • Number of events 6 • 48 hours
16.3%
22/135 • Number of events 22 • 48 hours
23.9%
32/134 • Number of events 32 • 48 hours
Nervous system disorders
Headache
2.2%
3/136 • Number of events 3 • 48 hours
9.6%
13/135 • Number of events 13 • 48 hours
8.2%
11/134 • Number of events 11 • 48 hours
Nervous system disorders
Somnolence
1.5%
2/136 • Number of events 2 • 48 hours
5.9%
8/135 • Number of events 8 • 48 hours
4.5%
6/134 • Number of events 6 • 48 hours
Skin and subcutaneous tissue disorders
Pruritis
0.74%
1/136 • Number of events 1 • 48 hours
12.6%
17/135 • Number of events 17 • 48 hours
9.7%
13/134 • Number of events 13 • 48 hours
Vascular disorders
Flushing
1.5%
2/136 • Number of events 2 • 48 hours
16.3%
22/135 • Number of events 22 • 48 hours
11.2%
15/134 • Number of events 15 • 48 hours

Additional Information

Dr. Ron Spivey

Acura Pharma

Phone: 847-705-7709

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place