| Primary | Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12). | The primary outcome measure is the summed pain intensity difference to baseline over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The observed SPID-12 scores ranged from -42.15 to 71.87 in the active group and -34.96 to 64.37 in the placebo group. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity. | | Posted | | Least Squares Mean | Standard Error | units on a scale | | 12 hours | | | | ID | Title | Description |
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| OG000 | Sufentanil Tablet 30 mcg | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg | | OG001 | Placebo Tablet | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00025.84± 1.71
- OG00113.14± 2.35
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| Secondary | Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24). | The primary outcome measure is the summed pain intensity difference to baseline over the 24-hour study period (SPID-24). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 24 hour study period. The SPID-24 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The observed SPID-24 scores ranged from -70.00 to 148.70 in the active group to -58.09 to 160.24 in the placebo group. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity. | | Posted | | Least Squares Mean | Standard Error | units on a scale | | 24 hours | | | | ID | Title | Description |
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| OG000 | Sufentanil Tablet 30 mcg | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg | | OG001 | Placebo Tablet | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet |
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| Secondary | TOTPAR12 | Total pain relief over the 12 hours. The observed total pain relief scores ranged from 4.08 to 47.50 in the active group and 1.77 to 33.71 in the placebo group. A higher score indicates greater pain relief. | | Posted | | Least Squares Mean | Standard Error | units on a scale | | 12 hours | | | | ID | Title | Description |
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| OG000 | Sufentanil Tablet 30 mcg | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg | | OG001 | Placebo Tablet | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet |
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| Secondary | TOTPAR24 | Total pain relief over the 24 hour study period. The observed total pain relief scores ranged from 12.35 to 95.23 in the active group and 2.61 to 82.04 in the placebo group. A higher score indicates greater pain relief. | | Posted | | Least Squares Mean | Standard Error | units on a scale | | 24 Hours | | | | ID | Title | Description |
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| OG000 | Sufentanil Tablet 30 mcg | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg | | OG001 | Placebo Tablet | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet |
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| Secondary | Time-weighted SPRID12 | Time-weighted summed pain relief intensity difference (SPRID) over the 12 hour study period. The observed SPRID scores ranged from -38.08 to 106.82 in the active group and -20.10 to 95.72 in the placebo group. A negative score indicates an increase in pain intensity and decrease in pain relief, while a higher score indicates a greater decrease in pain intensity and increase in pain relief. | | Posted | | Least Squares Mean | Standard Error | units on a scale | | 12 hours | | | | ID | Title | Description |
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| OG000 | Sufentanil Tablet 30 mcg | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg | | OG001 | Placebo Tablet | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet |
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| Secondary | Time-weighted SPRID24 | Time-weighted summed pain relief intensity difference (SPRID) over the 24 hour study period. The observed SPRID scores ranged from -49.67 to 222.04 in the active group and -24.97 to 237.54 in the placebo group. A negative score indicates an increase in pain intensity and decrease in pain relief, while a higher score indicates a greater decrease in pain intensity and increase in pain relief. | | Posted | | Least Squares Mean | Standard Error | units on a scale | | 24 hours | | | | ID | Title | Description |
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| OG000 | Sufentanil Tablet 30 mcg | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg | | OG001 | Placebo Tablet | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet |
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| Secondary | Patient Global Assessment | Proportion of patients who responded good or excellent to the global assessment of method of pain control at 24 hours | | Posted | | Number | 95% Confidence Interval | Percentage of patients | | 24 hours | | | | ID | Title | Description |
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| OG000 | Sufentanil Tablet 30 mcg | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg | | OG001 | Placebo Tablet | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet |
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| Secondary | Healthcare Professional Global Assessment | Proportion of Health Care Professionals who responded good or excellent to the global assessment of method of pain control at 24 hours | | Posted | | Number | 95% Confidence Interval | Percentage of HCPs | | 24 hours | | | | ID | Title | Description |
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| OG000 | Sufentanil Tablet 30 mcg | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg | | OG001 | Placebo Tablet | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet |
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| Secondary | Summed Pain Intensity Difference | The SPID-1 is calculated by summing the difference to baseline between baseline pain score and the pain score at each assessment time point through 1 hour. The observed SPID scores ranged from -2.00 to 5.25 in the active group to -4.90 to 3.00 in the placebo group. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity. | | Posted | | Least Squares Mean | Standard Error | units on a scale | | 1 hour | | | | ID | Title | Description |
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| OG000 | Sufentanil Tablet 30 mcg | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg | | OG001 | Placebo Tablet | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet |
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| Secondary | Analysis of Total Number of Doses Used During the 12-Hour Study Period in the ITT Population | | | Posted | | Mean | Standard Deviation | mean number of tablets taken | | Cumulative through 12 hours | | | | ID | Title | Description |
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| OG000 | Sufentanil Tablet 30 mcg | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg | | OG001 | Placebo Tablet | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet |
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| Secondary | Analysis of Total Number of Doses Used During the 24-Hour Study Period in the ITT Population | | | Posted | | Mean | Standard Deviation | mean number of tablets taken | | 24 hours | | | | ID | Title | Description |
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| OG000 | Sufentanil Tablet 30 mcg | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg | | OG001 | Placebo Tablet | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet |
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| Secondary | Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population | | | Posted | | Mean | Standard Deviation | mean number of doses used | | Cumulative through 6 hours | | | | ID | Title | Description |
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| OG000 | Sufentanil Tablet 30 mcg | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg | | OG001 | Placebo Tablet | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet |
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| Secondary | Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population | | | Posted | | Mean | Standard Deviation | mean number of doses used | | Cumulative through 12 hours | | | | ID | Title | Description |
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| OG000 | Sufentanil Tablet 30 mcg | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg | | OG001 | Placebo Tablet | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet |
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| Secondary | Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population | | | Posted | | Mean | Standard Deviation | mean number of doses used | | Cumulative through 24 hours | | | | ID | Title | Description |
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| OG000 | Sufentanil Tablet 30 mcg | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg | | OG001 | Placebo Tablet | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet |
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