Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02356588 | A Trial Evaluating the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for Post-Operative Pain After Abdominal Surgery | PHASE3 | COMPLETED | 161 | — | — | Feb 1, 2015 | Aug 1, 2015 | Feb 13, 2017 | 4 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| Sufentanil Tablet 30 mcg | EXPERIMENTAL | 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 | PLACEBO_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| Sufentanil Tablet 30 mcg | DRUG | - |
| Placebo Tablet | DRUG | - |
Inclusion Criteria (additional criteria not specified here): 1. Patients who are scheduled to undergo one of the following procedures with general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation: * abdominoplasty * open tension-free inguinal her...