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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01539538 | A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™)to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain | PHASE3 | COMPLETED | 357 | — | — | Apr 1, 2012 | Dec 1, 2012 | Oct 1, 2015 | 16 | United States |
| NCT01539642 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) for the Treatment of Post-Operative Pain in Patients After Open Abdominal Surgery | PHASE3 | COMPLETED | 172 | — | — | Feb 1, 2012 | Feb 1, 2013 | Oct 20, 2015 | 12 | United States |
Proportion of patients responding good or excellent at 48-hour global assessment of method of pain control
SPID-48 is the sum of the pain intensity difference (PID) over the 48 hour time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is obtained before starting the study and throughout the 48 time period. The pain score at each assessment time is subtracted from the baseline pain score to provide the total sum score or SPID-48. A higher SPID-48 is better and indicates a reduction in pain intensity compared to the baseline score. The range of SPID48 scores were -232 to 326. Time-weighted SPID48 = ∑ \[T(i) - T(i-1)\] x PID(i), where T(0) = Time 0 (baseline), T(i) is the scheduled or unscheduled assessment time, and PID(i) is the PID score at time i for i=0 to 48 hours. Note: Active group n=114 and placebo group n=58, instead of active n=115 and placebo n=57, due to one "active" patient receiving placebo inadvertently.
| Arm | Type | Description |
|---|---|---|
| Sufentanil NanoTab PCA System/15 mcg | EXPERIMENTAL | - |
| morphine IV PCA | ACTIVE_COMPARATOR | - |
| Placebo Sufentanil NanoTab PCA System | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Sufentanil NanoTab PCA System/15 mcg | DRUG | 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours |
| morphine IV PCA | DRUG | 1 mg morphine administered IV q 6 minutes as needed for pain for at least 48 hours and up to 72 hours |
| Placebo Sufentanil NanoTab PCA System | DRUG | Placebo NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patient may elect to remain in study for up to 72 hours. |
Inclusion Criteria: * Male or female patients who are 18 years or older * Patients who are scheduled to undergo an open abdominal surgery (including laparoscopic-assisted), total knee or total hip replacement surgery under general anesthesia or spinal anesthesia that does not include intrathecal op...