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| Name | Class |
|---|---|
| King Pharmaceuticals is now a wholly owned subsidiary of Pfizer | INDUSTRY |
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The primary objective of this study is to compare the relative abuse potential of two different doses of orally administered Acurox Tablets to orally administered immediate-release (IR) oxycodone HCl tablets in non-dependent recreational opioid users.
In the tretament phase, 5 treatments administered were oxycodone HCl/niacin tablets as follows: (A) 40/0 mg, (B) 80/0 mg, (C) (40/240 mg, (D) 80/480 mg and (E) 0/0 mg. Each treatment was administered as a single dose of 8 tablets once a day at approximately the same time each day. All doses were given with water, and all 8 tablets were to be swallowed in 5 minutes. Doses were separated by 48 (± 1) hours. All subjects received each treatment in a randomized sequence using a Williams design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 40/0mg taken first | Active Comparator | 8x oxycodone/niacin 5/0mg tablets |
|
| 80/0mg taken first | Active Comparator | 8x oxycodone/niacin 10/0mg tablets |
|
| 40/240mg taken first | Experimental | 8x oxycodone/niacin 5/30mg tablets |
|
| 80/480mg taken first | Experimental | 8x oxycodone/niacin 10/60mg tablets |
|
| 0/0mg taken first | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 40/0mg taken first | Drug | 8x Oxycodone/Niacin 5/0mg tablets All arms taken with a 48 hour washout between doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Drug Liking at .5 Hours | Drug Liking/Disliking Assessment on a 101 point bipolar visual analog scale (VAS) used to assess response to the question "Do you dislike or like the drug effect you are feeling now?" and anchored in the center with "Neither like nor dislike" (score of 50), on the left with "Dislike an awful lot" (score of 0) and on the right with "Like an awful lot" (score of 100). | Measure collected at 0.5 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lynne Webster, MD | Lifetree Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lifetree Clinical Research | Salt Lake City | Utah | 84106 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 40/0mg Taken First | Ocycodone/Naicin 40/0mg Tablets |
| FG001 | 80/0mg Taken First | Oxycodone/Niacin 80/0mg tablets |
| FG002 | 40/240mg Taken First | Oxycodone?Niacin 40/240mg tablets |
| FG003 | 80/480mg Taken First | Oxycodone/Naicin 80/480mg |
| FG004 | 0/0mg Taken First | Placebo: Tablets |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Crossover design. Subjects took all drugs in randomized order with a 48 hour washout between doses
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| ID | Title | Description |
|---|---|---|
| BG000 | 40/0mg Taken First | oxycodone.naicin 40/0mg tablets |
| BG001 | 80/0mg Taken First | oxycodone.naicin 80/0mg tablets |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Drug Liking at .5 Hours | Drug Liking/Disliking Assessment on a 101 point bipolar visual analog scale (VAS) used to assess response to the question "Do you dislike or like the drug effect you are feeling now?" and anchored in the center with "Neither like nor dislike" (score of 50), on the left with "Dislike an awful lot" (score of 0) and on the right with "Like an awful lot" (score of 100). | Per protocol completers | Posted | Mean | Standard Deviation | score on a scale | Measure collected at 0.5 hours post-dose |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 40/0mg | Oxycodone hcl 40mg | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flushing | Vascular disorders | MedDRA | Systematic Assessment | Flushing |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ron Spivey | Acura Pharma | 847-705-7709 | rspivey@acurapharm.com |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Matching white tablets
| 80/0mg taken first | Drug | 8x Oxycodone/Niacin 10/0mg tablets All arms taken with a 48 hour washout between doses |
|
| 40/240mg taken first | Drug | 8x Oxycodone/Niacin 5/30mg tablets All arms taken with a 48 hour washout between doses |
|
| 80/480mg taken first | Drug | 8x Oxycodone/Niacin 10/60mg tablets All arms taken with a 48 hour washout between doses |
|
| 0/0mg taken first | Drug | Placebo All arms taken with a 48 hour washout between doses |
|
| BG002 |
| 40/240mg Taken First |
oxycodone.naicin 40/240mg tablets |
| BG003 | 80/480mg Taken First | oxycodone.naicin 80/480mg tablets |
| BG004 | 0/0mg Taken First | Placebo Tablets |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | 2 drop out; 1 protocol violation | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 40/240mg | 8x Oxycodone/Naicin 5/30mg tablets |
| OG003 | 80/480mg | 8x Oxycodone/Naicin 10/60mg tablets |
| OG004 | 0/0mg | Placebo: Tablets |
|
|
| 49 |
| 0 |
| 49 |
| 37 |
| 49 |
| EG001 | 80/0mg | Oxycodone hcl 40mg | 0 | 49 | 0 | 49 | 46 | 49 |
| EG002 | 40/240mg | Oxycodone hcl 40mg/niacin 240mg | 0 | 49 | 0 | 49 | 47 | 49 |
| EG003 | 80/480ng | Oxycodone hcl 80mg/niacin 480mg | 0 | 49 | 0 | 49 | 49 | 49 |
| EG004 | 0/0mg | Placebo: Tablets | 0 | 49 | 0 | 49 | 3 | 49 |
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | MEDRA (10.0) | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
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