| Primary | Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours | 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 visual analogue scale (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 (0-2) = Area under the effect versus time curve from time 0 to 2 hours (hrs) (0-2). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose pharmacodynamic (PD) data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5 and 2 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00088.3± 4.41(83.6 to 93.6)
- OG001100.3± 12.29(95.5 to 105.5)
- OG002124.7± 22.70(120.4 to 130.4)
|
|
| | 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 |
|---|
| Least square (LS) mean and 95% confidence interval (CI) were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence. | Mixed Models Analysis | | <0.0001 | p-value adjusted for multiple comparisons with Hochberg adjustment. At least one primary outcome for each of drug liking and high was required to be significant with adjusted p-value less than or equal to 0.05. | LS Mean Difference | -24.9 | | | 2-Sided | 95 | -31.7 | -18.1 | | | | No | Superiority or Other | |
|
| 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 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). Emax = Maximum observed score. | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | mm | | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| Primary | High: Area Under Effect Curve (AUE) From 0-2 Hours | High 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 (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5 and 2 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Drug Liking: Area Under Effect Curve (AUE) From 0-1 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 (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5 and 1 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| Secondary | Drug Liking: Area Under Effect Curve (AUE) From 0-4 Hours | 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 (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| Secondary | Drug Liking: Area Under Effect Curve (AUE) From 0-8 Hours | 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 (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| Secondary | Drug Liking: Area Under Effect Curve (AUE) From 0-12 Hours | 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 (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| Secondary | Drug Liking: Area Under Effect Curve (AUE) From 0-24 Hours | 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 (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| Secondary | 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. | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs | | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| Secondary | High: Area Under Effect Curve (AUE) From 0-1 Hour | High 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 (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5 and 1 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | High: Area Under Effect Curve (AUE) From 0-4 Hours | High 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 (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | High: Area Under Effect Curve (AUE) From 0-8 Hours | High 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 (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | High: Area Under Effect Curve (AUE) From 0-12 Hours | High 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 (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | High: Area Under Effect Curve (AUE) From 0-24 Hours | High 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 (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| Secondary | 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 a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs | | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Good Effects: Area Under Effect Curve (AUE) From 0-1 Hour | Good effects 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 (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5 and 1 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Good Effects: Area Under Effect Curve (AUE) From 0-2 Hours | Good effects 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 (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5 and 2 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Good Effects: Area Under Effect Curve (AUE) From 0-4 Hours | Good effects 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 (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Good Effects: Area Under Effect Curve (AUE) From 0-8 Hours | Good effects 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 (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| Secondary | Good Effects: Area Under Effect Curve (AUE) From 0-12 Hours | Good effects 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 (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| Secondary | Good Effects: Area Under Effect Curve (AUE) From 0-24 Hours | Good effects 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 (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| Secondary | Good Effects: Peak Effect (Emax) | Good effects 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). Emax = Maximum observed score. | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | mm | | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Good Effects: Time to Maximum (Peak) Effect (TEmax) | Good effects 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. | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs | | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Any Effects: Area Under Effect Curve (AUE) From 0-1 Hour | Any effects 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 (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5 and 1 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Any Effects: Area Under Effect Curve (AUE) From 0-2 Hours | Any effects 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 (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5 and 2 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Any Effects: Area Under Effect Curve (AUE) From 0-4 Hours | Any effects 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 (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Any Effects: Area Under Effect Curve (AUE) From 0-8 Hours | Any effects 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 (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| Secondary | Any Effects: Area Under Effect Curve (AUE) From 0-12 Hours | Any effects 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 (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| Secondary | Any Effects: Area Under Effect Curve (AUE) From 0-24 Hours | Any effects 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 (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| Secondary | Any Effects: Peak Effect (Emax) | Any effects 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). Emax = Maximum observed score. | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | mm | | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Any Effects: Time to Maximum (Peak) Effect (TEmax) | Any effects 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. | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs | | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Bad Effects: Area Under Effect Curve (AUE) From 0-1 Hour | Bad effects 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 (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5 and 1 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Bad Effects: Area Under Effect Curve (AUE) From 0-2 Hours | Bad effects 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 (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5 and 2 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Bad Effects: Area Under Effect Curve (AUE) From 0-4 Hours | Bad effects 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 (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Bad Effects: Area Under Effect Curve (AUE) From 0-8 Hours | Bad effects 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 (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| Secondary | Bad Effects: Area Under Effect Curve (AUE) From 0-12 Hours | Bad effects 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 (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| Secondary | Bad Effects: Area Under Effect Curve (AUE) From 0-24 Hours | Bad effects 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 (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| Secondary | Bad Effects: Peak Effect (Emax) | Bad effects 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). Emax = Maximum observed score. | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | mm | | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Bad Effects: Time to Maximum (Peak) Effect (TEmax) | Bad effects 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. | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs | | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Nausea: Area Under Effect Curve (AUE) From 0-1 Hour | Nausea 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 (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | Pre-dose, 0.5 and 1 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Nausea: Area Under Effect Curve (AUE) From 0-2 Hours | Nausea 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 (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Nausea: Area Under Effect Curve (AUE) From 0-4 Hours | Nausea 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 (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Nausea: Area Under Effect Curve (AUE) From 0-8 Hours | Nausea 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 (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| Secondary | Nausea: Area Under Effect Curve (AUE) From 0-12 Hours | Nausea 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 (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| Secondary | Nausea: Area Under Effect Curve (AUE) From 0-24 Hours | Nausea 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 (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| 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 a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | mm | | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third 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 a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs | | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour | Feel sick 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 (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5 and 1 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Feel Sick: Area Under Effect Curve (AUE) From 0-2 Hours | Feel sick 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 (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5 and 2 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Feel Sick: Area Under Effect Curve (AUE) From 0-4 Hours | Feel sick 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 (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Feel Sick: Area Under Effect Curve (AUE) From 0-8 Hours | Feel sick 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 (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Feel Sick: Area Under Effect Curve (AUE) From 0-12 Hours | Feel sick 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 (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| Secondary | Feel Sick: Area Under Effect Curve (AUE) From 0-24 Hours | Feel sick 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 (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| 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 a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | mm | | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third 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 a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs | | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Sleepy: Area Under Effect Curve (AUE) From 0-1 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 (0-1) = Area under the effect versus time curve from time 0 to 1 hr(0-1). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5 and 1 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours | 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 (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5 and 2 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Sleepy: Area Under Effect Curve (AUE) From 0-4 Hours | 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 (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Sleepy: Area Under Effect Curve (AUE) From 0-8 Hours | 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 (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of EMBEDA solution containing 120 mg morphine sulfate / 4.8 mg naltrexone hydrochloride administered orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Sleepy: Area Under Effect Curve (AUE) From 0-12 Hours | 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 (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| Secondary | Sleepy: Area Under Effect Curve (AUE) From 0-24 Hours | 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 (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| 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 a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | mm | | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third 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. | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs | | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Dizzy: Area Under Effect Curve (AUE) From 0-1 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 (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5 and 1 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours | 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 (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5 and 2 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Dizzy: Area Under Effect Curve (AUE) From 0-4 Hours | 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 (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third 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 a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | mm | | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Dizzy: Area Under Effect Curve (AUE) From 0-8 Hours | 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 (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Dizzy: Area Under Effect Curve (AUE) From 0-12 Hours | 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 (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Dizzy: Area Under Effect Curve (AUE) From 0-24 Hours | 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 (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| 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 a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | mm | | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third 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. | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs | | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Overall Drug Liking Effect at 24 Hours | 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 carryover 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"). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | mm | | 24 hrs post dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| Secondary | Take Drug Again Effect at 24 Hours | 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"). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | mm | | 24 hrs post dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour | Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | Pre-dose, 0.5 and 1 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| Secondary | Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours | Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| Secondary | Pupillometry: Area Under Effect Curve (AUE) From 0-4 Hours | Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| Secondary | Pupillometry: Area Under Effect Curve (AUE) From 0-8 Hours | Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| Secondary | Pupillometry: Area Under Effect Curve (AUE) From 0-12 Hours | Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| Secondary | Pupillometry: Area Under Effect Curve (AUE) From 0-24 Hours | Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24). | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs*mm | | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| Secondary | Pupillometry: Peak Effect (Emax) | Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. Emax = Smallest post-dose pupil size. | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | mm | | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| Secondary | Pupillometry: Time to Maximum (Peak) Effect (TEmax) | Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. TEmax = Time to smallest post-dose pupil size. | The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations. | Posted | | Mean | Standard Deviation | hrs | | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Single dose of matching placebo solution orally in either of the first to third intervention periods. | | OG001 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG002 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Morphine | | Safety population included all participants who received at least one dose of study drug in the Treatment Phase. | Posted | | Mean | Standard Deviation | hrs | | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG001 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Morphine | | Safety population included all participants who received at least one dose of study drug in the Treatment Phase. | Posted | | Mean | Standard Deviation | picogram/milliliter (pg/mL) | | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG001 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Morphine | AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1). | Safety population included all participants who received at least one dose of study drug in the Treatment Phase. | Posted | | Mean | Standard Deviation | hrs*pg/mL | | Pre-dose, 0.5 and 1 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG001 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Morphine | AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2). | Safety population included all participants who received at least one dose of study drug in the Treatment Phase. | Posted | | Mean | Standard Deviation | hrs*pg/mL | | Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG001 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Morphine | AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4). | Safety population included all participants who received at least one dose of study drug in the Treatment Phase. | Posted | | Mean | Standard Deviation | hrs*pg/mL | | Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG001 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Morphine | AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8). | Safety population included all participants who received at least one dose of study drug in the Treatment Phase. | Posted | | Mean | Standard Deviation | hrs*pg/mL | | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG001 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Morphine | AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12). | Safety population included all participants who received at least one dose of study drug in the Treatment Phase. | Posted | | Mean | Standard Deviation | hrs*pg/mL | | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG001 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Morphine | AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24). | Safety population included all participants who received at least one dose of study drug in the Treatment Phase. | Posted | | Mean | Standard Deviation | hrs*pg/mL | | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG001 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Morphine | AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). | Safety population included all participants who received at least one dose of study drug in the Treatment Phase. | Posted | | Mean | Standard Deviation | hrs*pg/mL | | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. | | OG001 | Morphine | Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods. |
| |
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone | | Safety population included all participants who received at least one dose of study drug in the Treatment Phase. | Posted | | Mean | Standard Deviation | hrs | | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. |
| | |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Naltrexone | | Safety population included all participants who received at least one dose of study drug in the Treatment Phase. | Posted | | Mean | Standard Deviation | pg/mL | | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. |
| | |
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Naltrexone | AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1). | Safety population included all participants who received at least one dose of study drug in the Treatment Phase. | Posted | | Mean | Standard Deviation | hrs*pg/mL | | Pre-dose, 0.5 and 1 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. |
| |
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Naltrexone | AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2). | Safety population included all participants who received at least one dose of study drug in the Treatment Phase. | Posted | | Mean | Standard Deviation | hrs*pg/mL | | Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. |
| |
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Naltrexone | AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4). | Safety population included all participants who received at least one dose of study drug in the Treatment Phase. | Posted | | Mean | Standard Deviation | hrs*pg/mL | | Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. |
| |
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Naltrexone | AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8). | Safety population included all participants who received at least one dose of study drug in the Treatment Phase. | Posted | | Mean | Standard Deviation | hrs*pg/mL | | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. |
| |
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Naltrexone | AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12). | Safety population included all participants who received at least one dose of study drug in the Treatment Phase. | Posted | | Mean | Standard Deviation | hrs*pg/mL | | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. |
| |
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Naltrexone | AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24). | Safety population included all participants who received at least one dose of study drug in the Treatment Phase. | Posted | | Mean | Standard Deviation | hrs*pg/mL | | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. |
| |
| Secondary | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone | AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). | Safety population included all participants who received at least one dose of study drug in the Treatment Phase. | Posted | | Mean | Standard Deviation | hrs*pg/mL | | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. |
| |
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone Metabolite (6-beta-naltrexol) | | Safety population included all participants who received at least one dose of study drug in the Treatment Phase. | Posted | | Mean | Standard Deviation | hrs | | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. |
| | |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Naltrexone Metabolite (6-beta-naltrexol) | | Safety population included all participants who received at least one dose of study drug in the Treatment Phase. | Posted | | Mean | Standard Deviation | pg/mL | | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. |
| | |
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Naltrexone Metabolite (6-beta-naltrexol) | AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1). | Safety population included all participants who received at least one dose of study drug in the Treatment Phase. | Posted | | Mean | Standard Deviation | hrs*pg/mL | | Pre-dose, 0.5 and 1 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. |
| |
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Naltrexone Metabolite (6-beta-naltrexol) | AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2). | Safety population included all participants who received at least one dose of study drug in the Treatment Phase. | Posted | | Mean | Standard Deviation | hrs*pg/mL | | Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. |
| |
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Naltrexone Metabolite (6-beta-naltrexol) | AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4). | Safety population included all participants who received at least one dose of study drug in the Treatment Phase. | Posted | | Mean | Standard Deviation | hrs*pg/mL | | Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. |
| |
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Naltrexone Metabolite (6-beta-naltrexol) | AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8). | Safety population included all participants who received at least one dose of study drug in the Treatment Phase. | Posted | | Mean | Standard Deviation | hrs*pg/mL | | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. |
| |
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Naltrexone Metabolite (6-beta-naltrexol) | AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12). | Safety population included all participants who received at least one dose of study drug in the Treatment Phase. | Posted | | Mean | Standard Deviation | hrs*pg/mL | | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. |
| |
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Naltrexone Metabolite (6-beta-naltrexol) | AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24). | Safety population included all participants who received at least one dose of study drug in the Treatment Phase. | Posted | | Mean | Standard Deviation | hrs*pg/mL | | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. |
| |
| Secondary | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone Metabolite (6-beta-naltrexol) | AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). | Safety population included all participants who received at least one dose of study drug in the Treatment Phase. | Posted | | Mean | Standard Deviation | hrs*pg/mL | | Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose | | | | ID | Title | Description |
|---|
| OG000 | EMBEDA | Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods. |
| |