Trial Outcomes & Findings for Study of the Abuse Liability of Oxycodone HCl/Niacin in Subjects With a History of Opioid Abuse (NCT NCT00699010)
NCT ID: NCT00699010
Last Updated: 2018-10-03
Results Overview
"Do you dislike or like the drug effect you are feeling now?" This question was rated on a 1 to 29 point VAS scale that was anchored in the center with "neither like nor dislike" (14), on the left with "dislike an awful lot" (1), and on the right with "like an awful lot" (29).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Effects assessed at 0.5 hours after dosing.
Results posted on
2018-10-03
Participant Flow
Participant milestones
| Measure |
Acurox 5/30mg Taken First
Oxycodone HCl/Niacin 5/30mg; 8 tablet dose followed by oxycodone 5mg with 48 hour washout
|
Oxycodone 5mg Taken First
Oxycodone Hcl 5mg; 8 tablet dose follwed by Acurox 5/30mg with 48 hour washout
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Abuse Liability of Oxycodone HCl/Niacin in Subjects With a History of Opioid Abuse
Baseline characteristics by cohort
| Measure |
Acurox 5/30mg Taken First
n=15 Participants
Oxycodone HCL/Niacin 5/30mg; 8 tablet dose followed by Oxycodone 5mg with 48 hour washout
|
Oxycodone 5mg Taken First
n=15 Participants
Oxycodone HCL 5mg; 8 tablet dose followed by Acurox 5/30mg with 48 hour washout
|
Total
n=30 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
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
44.7 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
44.7 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
44.7 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Effects assessed at 0.5 hours after dosing.Population: Study completers and per protocol
"Do you dislike or like the drug effect you are feeling now?" This question was rated on a 1 to 29 point VAS scale that was anchored in the center with "neither like nor dislike" (14), on the left with "dislike an awful lot" (1), and on the right with "like an awful lot" (29).
Outcome measures
| Measure |
Acurox 5/30mg
n=30 Participants
Oxycodone HCL/Niacin 5/30mg; 8 tablet dose
|
Oxycodone 5mg
n=30 Participants
Oxycodone 5mg; 8 tablet dose
|
|---|---|---|
|
Drug Like/Dislike Effect at 30 Minutes Post Dose (E 30 Min)
|
11.7 score on a scale
Standard Error 1.0
|
14.7 score on a scale
Standard Error 1.0
|
Adverse Events
Acurox 5/30mg
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Oxycodone 5mg
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Acurox 5/30mg
n=30 participants at risk
Oxycodone HCL/Niacin 5/30mg; 8 tablet dose
|
Oxycodone 5mg
n=30 participants at risk
Oxycodone HCl 5mg; 8 tablet dose
|
|---|---|---|
|
Vascular disorders
Flushing
|
76.7%
23/30 • Number of events 23 • 11 days. Doses taken 1 per day with a 48 hours washout
|
16.7%
5/30 • Number of events 5 • 11 days. Doses taken 1 per day with a 48 hours washout
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
70.0%
21/30 • Number of events 21 • 11 days. Doses taken 1 per day with a 48 hours washout
|
70.0%
21/30 • Number of events 21 • 11 days. Doses taken 1 per day with a 48 hours washout
|
|
Gastrointestinal disorders
Nausea
|
26.7%
8/30 • Number of events 8 • 11 days. Doses taken 1 per day with a 48 hours washout
|
30.0%
9/30 • Number of events 9 • 11 days. Doses taken 1 per day with a 48 hours washout
|
|
Nervous system disorders
Euphoria
|
43.3%
13/30 • Number of events 13 • 11 days. Doses taken 1 per day with a 48 hours washout
|
50.0%
15/30 • Number of events 15 • 11 days. Doses taken 1 per day with a 48 hours washout
|
|
Skin and subcutaneous tissue disorders
Paraesthesia
|
36.7%
11/30 • Number of events 11 • 11 days. Doses taken 1 per day with a 48 hours washout
|
10.0%
3/30 • Number of events 3 • 11 days. Doses taken 1 per day with a 48 hours washout
|
|
Nervous system disorders
Somnolence
|
26.7%
8/30 • Number of events 8 • 11 days. Doses taken 1 per day with a 48 hours washout
|
30.0%
9/30 • Number of events 9 • 11 days. Doses taken 1 per day with a 48 hours washout
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
4/30 • Number of events 4 • 11 days. Doses taken 1 per day with a 48 hours washout
|
10.0%
3/30 • Number of events 3 • 11 days. Doses taken 1 per day with a 48 hours washout
|
|
Nervous system disorders
Headache
|
26.7%
8/30 • Number of events 8 • 11 days. Doses taken 1 per day with a 48 hours washout
|
23.3%
7/30 • Number of events 7 • 11 days. Doses taken 1 per day with a 48 hours washout
|
|
Nervous system disorders
Dizziness
|
20.0%
6/30 • Number of events 6 • 11 days. Doses taken 1 per day with a 48 hours washout
|
3.3%
1/30 • Number of events 1 • 11 days. Doses taken 1 per day with a 48 hours washout
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place