| Primary | Drug Liking: Peak Effect (Emax) | Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the extreme left with "strong disliking" (score of 0 mm) and on the extreme right with "strong liking" (score of 100 mm). Peak Effect (Emax) = Maximum observed score. | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period. | Posted | | Mean | Standard Deviation | mm | | 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose in treatment phase | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | | OG003 | ALO-02 60 Mg-I | Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods. | | OG004 | ALO-02 60 mg- C | Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods. | | OG005 | OXY 60 mg | Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods. |
| | Units | Counts |
|---|
| Participants | - OG00032
- OG00132
- OG00232
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00051.6± 3.74
- OG00170.1± 19.23
- OG00285.5± 16.11
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect. | Mixed Models Analysis | | <0.0001 | | Least Squares (LS) Mean Difference | 30.5 | | | 2-Sided | 95 | 24.4 | 36.6 | | | | | Superiority or Other | | | | |
|
| Primary | Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hour | Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the extreme left with "strong disliking" (score of 0 mm) and on the extreme right with "strong liking" (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours. | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Mean | Standard Deviation | hours*mm | | 0.25, 0.5, 1, 1.5, 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. |
|
| Primary | High: Peak Effect (Emax) | High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Mean | Standard Deviation | mm | | 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose in treatment phase | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | | OG003 | ALO-02 60 Mg-I |
|
| Primary | High: Area Under Effect Curve (AUE) From 0-2 Hour | High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours. | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Mean | Standard Deviation | hours*mm | | pre-dose, 0.25, 0.5, 1, 1.5, 2 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | | OG003 | ALO-02 60 Mg-I |
|
| Secondary | Take Drug Again: Peak Effect (Emax) | Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = "definitely would not", 50 mm = "do not care", and 100 mm = "definitely would"). Emax = Maximum observed score. | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Mean | Standard Deviation | mm | | 12, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | | OG003 |
|
| Secondary | Take Drug Again: Mean Effect (Emean) | Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = "definitely would not", 50 mm = "do not care", and 100 mm = "definitely would"). Emax = Maximum observed score. | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Mean | Standard Deviation | mm | | 12, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | | OG003 |
|
| Secondary | Take Drug Again: Minimum Effect (Emin) | Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = "definitely would not", 50 mm = "do not care", and 100 mm = "definitely would"). Emax = Maximum observed score. | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Mean | Standard Deviation | mm | | 12, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | | OG003 |
|
| Secondary | Take Drug Again Effect at Hours 12, 24 and 36 | Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = "definitely would not", 50 mm = "do not care", and 100 mm = "definitely would"). Emax = Maximum observed score. | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Mean | Standard Deviation | mm | | 12, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | | OG003 |
|
| Secondary | Overall Drug Liking: Peak Effect (Emax) | Overall drug liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = "strong disliking", 50 mm = "neither like nor dislike", and 100 mm= "strong liking"). Emax = Maximum observed score. | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Mean | Standard Deviation | mm | | 12, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | |
|
| Secondary | Overall Drug Liking: Mean Effect (Emean) | Overall drug liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = "strong disliking", 50 mm = "neither like nor dislike", and 100 mm= "strong liking"). Emean = Average observed score. | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Mean | Standard Deviation | mm | | 12, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | |
|
| Secondary | Overall Drug Liking: Minimum Effect (Emin) | Overall drug liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = "strong disliking", 50 mm = "neither like nor dislike", and 100 mm= "strong liking"). Emin= Average observed score. | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Mean | Standard Deviation | mm | | 12, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | |
|
| Secondary | Overall Drug Liking Effect at Hours 12, 24 and 36 | Overall drug liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = "strong disliking", 50 mm = "neither like nor dislike", and 100 mm= "strong liking"). | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Mean | Standard Deviation | mm | | 12, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | | OG003 |
|
| Secondary | Any Drug Effects: Peak Effect (Emax) | Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Mean | Standard Deviation | mm | | 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | | OG003 | ALO-02 60 Mg-I |
|
| Secondary | Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour | Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Mean | Standard Deviation | hours*mm | | 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. |
|
| Secondary | Any Drug Effects: Time to Maximum (Peak) Effect (TEmax) | Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Median | Full Range | hours | | 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | | OG003 | ALO-02 60 Mg-I |
|
| Secondary | Good Drug Effects: Peak Effect (Emax) | Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Mean | Standard Deviation | mm | | 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | | OG003 | ALO-02 60 Mg-I |
|
| Secondary | Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour | Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Mean | Standard Deviation | hours*mm | | 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. |
|
| Secondary | Good Drug Effects: Time to Maximum (Peak) Effect (TEmax) | Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Median | Full Range | hours | | 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | | OG003 | ALO-02 60 Mg-I |
|
| Secondary | Bad Drug Effects: Peak Effect (Emax) | Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Mean | Standard Deviation | mm | | 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | | OG003 | ALO-02 60 Mg-I |
|
| Secondary | Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour | Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Mean | Standard Deviation | hours*mm | | 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. |
|
| Secondary | Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax) | Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Median | Full Range | hours | | 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | | OG003 | ALO-02 60 Mg-I |
|
| Secondary | Feel Sick: Peak Effect (Emax) | Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Mean | Standard Deviation | mm | | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | | OG003 | ALO-02 60 Mg-I |
|
| Secondary | Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour | Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Mean | Standard Deviation | hours*mm | | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. |
|
| Secondary | Feel Sick: Time to Maximum (Peak) Effect (TEmax) | Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Median | Full Range | hours | | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | | OG003 | ALO-02 60 Mg-I |
|
| Secondary | Nausea: Peak Effect (Emax) | Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Mean | Standard Deviation | mm | | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | | OG003 | ALO-02 60 Mg-I |
|
| Secondary | Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour | Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Mean | Standard Deviation | hours*mm | | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. |
|
| Secondary | Nausea: Time to Maximum (Peak) Effect (TEmax) | Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Median | Full Range | hours | | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | | OG003 | ALO-02 60 Mg-I |
|
| Secondary | Sleepy: Peak Effect (Emax) | Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Mean | Standard Deviation | mm | | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | | OG003 | ALO-02 60 Mg-I |
|
| Secondary | Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour | Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Mean | Standard Deviation | hours*mm | | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. |
|
| Secondary | Sleepy: Time to Maximum (Peak) Effect (TEmax) | Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm)to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Median | Full Range | hours | | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | | OG003 | ALO-02 60 Mg-I |
|
| Secondary | Dizzy: Peak Effect (Emax) | Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Mean | Standard Deviation | mm | | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | | OG003 | ALO-02 60 Mg-I |
|
| Secondary | Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour | Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Mean | Standard Deviation | hours*mm | | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. |
|
| Secondary | Dizzy: Time to Maximum (Peak) Effect (TEmax) | Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Median | Full Range | hours | | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | | OG003 | ALO-02 60 Mg-I |
|
| Secondary | Pupillometry: Peak Effect (Emax) | Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. The same eye for each participant was used for all measurements during the study. Emax = Maximum observed score. | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Mean | Standard Deviation | mm | | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. |
|
| Secondary | Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour | Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. The same eye for each participant was used for all measurements during the study. AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Mean | Standard Deviation | hours*mm | | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. |
|
| Secondary | Pupillometry: Time to Maximum (Peak) Effect (TEmax) | Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. The same eye for each participant was used for all measurements during the study. TEmax = Time to maximum observed score. | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Median | Full Range | hours | | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. |
|
| Other Pre-specified | Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour | Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x). | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Mean | Standard Deviation | hours*mm | | 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. |
|
| Other Pre-specified | Drug Liking: Time to Maximum (Peak) Effect (TEmax) | Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). TEmax = Time to maximum observed score. | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Median | Full Range | hours | | 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. |
|
| Other Pre-specified | High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour | High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x). | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Mean | Standard Deviation | hours*mm | | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | |
|
| Other Pre-specified | High: Time to Maximum (Peak) Effect (TEmax) | High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. | Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period. | Posted | | Median | Full Range | hours | | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | | OG003 | ALO-02 60 Mg-I |
|
| Other Pre-specified | Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of Oxycodone, Oxymorphone and Noroxycodone | Cmax[dn]=Dose normalized maximum observed plasma concentration of participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone. | Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the Pharmacokinetic (PK) parameters of interest. Here 'n' signifies those participants who were evaluable for specified category. | Posted | | Mean | Standard Deviation | nanogram/milliliter/milligram | | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG001 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | | OG002 | ALO-02 60 Mg-I | Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods. |
|
| Other Pre-specified | Maximum Observed Plasma Concentration (Cmax) of Naltrexone and 6-beta-naltrexol | Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone. | Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. | Posted | | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 40 Mg-C | Single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 60 Mg-I | Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods. | | OG002 | ALO-02 60 Mg-C | Single dose of ALO-02 60 mg/7.2 mg crushed tablet (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods. |
| |
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone, Oxymorphone and Noroxycodone | Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone. | Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. Here 'n' signifies those participants who were evaluable for specified category. | Posted | | Median | Full Range | hours | | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG001 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | | OG002 | ALO-02 60 Mg-I | Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods. | | OG003 |
|
| Other Pre-specified | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone and 6-beta-naltrexol | Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone. | Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. Here 'n' signifies those participants who were evaluable for specified category. | Posted | | Median | Full Range | hour | | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 40 Mg-C | Single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 60 Mg-I | Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods. | | OG002 | ALO-02 60 Mg-C | Single dose of ALO-02 60 mg/7.2 mg crushed tablet (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods. |
| |
| Other Pre-specified | Plasma Terminal Half-Life (t1/2) of Oxycodone | Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone. | Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | | Median | Full Range | hours | | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG001 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | | OG002 | ALO-02 60 Mg-I | Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods. | | OG003 |
|
| Other Pre-specified | Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour, 0-8 Hour 0-12 Hour and 0-24 Hour of Oxycodone | AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Participants who received oxycodone were reported. | Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. | Posted | | Mean | Standard Deviation | nanogram*hour/milliliter (ng*hr/mL) | | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG001 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | | OG002 | ALO-02 60 Mg-I | Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods. | | OG003 |
|
| Other Pre-specified | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Oxycodone | Area under the plasma concentration time-curve from zero to the last quantifiable concentration (AUClast). Participants who received oxycodone were reported. | Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. | Posted | | Mean | Standard Deviation | ng*hr/mL | | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG001 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | | OG002 | ALO-02 60 Mg-I | Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods. | | OG003 | ALO-02 60 mg- C |
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| Other Pre-specified | Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)dn] of Oxycodone | [AUC (0 - ∞)dn]= Dose normalized area under the plasma concentration versus time curve [AUC(dn)] from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0- t) plus AUC (t - ∞). Participants who received oxycodone were reported. Participants who received oxycodone were reported. | Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | | Mean | Standard Deviation | ng*hr/mL/mg | | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose | | | | ID | Title | Description |
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| OG000 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG001 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. | | OG002 | ALO-02 60 Mg-I | Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods. |
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| Other Pre-specified | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 3 - 7 days following last study drug administration. Symptoms of withdrawal following naloxone administration (naloxone challenge phase) were not collected as adverse events unless they met the criteria for an SAE. AEs included SAEs as well as non-serious AEs which occurred during the trial. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | | Number | | participants | | Screening up to 28 days after last study drug administration (Day 29) | | | | ID | Title | Description |
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| OG000 | Naloxone | Naloxone HCl 0.2 mg intravenously followed by additional 0.6 mg naloxone HCl intravenously, each dose followed by an assessment for signs and symptoms of opioid withdrawal in naloxone challenge phase. | | OG001 | Oxycodone HCl 40 mg | Single dose of oxycodone HCl 40 mg crushed tablet solution orally on either of 2 days in drug discrimination phase. |
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| Other Pre-specified | Number of Participants With Clinically Significant Change in Vital Sign Examinations | Vital signs assessment included measurement of heart rate, systolic and diastolic blood pressures, respiratory rate and oral temperature. Criteria for clinically significant change in any vital sign examination was based on investigator's discretion. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | | Number | | participants | | Screening up to 7 days following last study drug administration (Day 8) | | | | ID | Title | Description |
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| OG000 | Naloxone | Naloxone HCl 0.2 mg intravenously followed by additional 0.6 mg naloxone HCl intravenously, each dose followed by an assessment for signs and symptoms of opioid withdrawal in naloxone challenge phase. | | OG001 | Oxycodone HCl 40 mg | Single dose of oxycodone HCl 40 mg crushed tablet solution orally on either of 2 days in drug discrimination phase. | | OG002 | Placebo Oxycodone HCl | Single dose of placebo matched to oxycodone HCl crushed tablet solution orally on either of 2 days in drug discrimination phase. | | OG003 |
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| Other Pre-specified | Number of Participants With Clinically Significant Change in End Tidal Carbon Dioxide (EtCO2) | End-tidal carbon dioxide concentration in the expired air (EtCO2) was monitored using capnography in a sitting position. Criteria for clinically significant change in EtCO2 was based on investigator's discretion. | Safety analysis set included all participants who received at least 1 dose of study drug. This outcome measure was not planned to be analyzed in "Naloxone Challenge Phase", as pre-specified in protocol. | Posted | | Number | | participants | | pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5 hours post-dose in drug discrimination phase; pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose in intervention period | | | | ID | Title | Description |
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| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 | OXY 40 mg | Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods. |
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| Other Pre-specified | Number of Participants With Clinically Significant Change in Oxygen Saturation of Hemoglobin (SpO2) | Oxygen saturation of hemoglobin in blood (SpO2) was monitored using pulse oximetry continuously for 5 hours following dosing in the drug discrimination phase and continuously for 12 hours following dosing in the treatment phase, or longer at the discretion of the investigator. Individual measurements was collected in a sitting position. If SpO2 fall below 90 percent (%), the investigator might had administered oxygen via nasal cannula at a flow rate sufficient to maintain the SpO2 greater than or equal to 90%. Participants with fall in SpO2 below 90% were reported. | Safety analysis set included all participants who received at least 1 dose of study drug. This outcome measure was not planned to be analyzed in "Naloxone Challenge Phase", as pre-specified in protocol. | Posted | | Number | | participants | | pre-dose up to 5 hours in drug discrimination phase; pre-dose up to 12 hours in intervention period | | | | ID | Title | Description |
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| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to sixth intervention periods. | | OG001 | ALO-02 40 Mg-C | Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods. | | OG002 |
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