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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00478023 | A Study to Evaluate the Efficacy and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain After Abdominal Hysterectomy | PHASE3 | COMPLETED | 854 | — | — | May 1, 2007 | Apr 1, 2008 | Oct 28, 2019 | 52 | Hungary, Latvia +7 |
Pain Intensity assessed at predefined time points over a 24 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Differences calculated as \[baseline-post baseline\] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -240 (indicative of an increase in pain) to 240 (indicative of a decrease in pain, assuming patients start with a baseline value of 10 and all subsequent values will be 0).
| Arm | Type | Description |
|---|---|---|
| Morphine | ACTIVE_COMPARATOR | - |
| Tapentadol 50 mg immediate release | EXPERIMENTAL | - |
| Tapentadol 75 mg immediate release | EXPERIMENTAL | - |
| Tapentadol 100 mg immediate release | EXPERIMENTAL | - |
| Matched placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Morphine | DRUG | 20 mg IR; 4 - 6 hourly; Total 72 hours |
| CG5503 IR | DRUG | 50mg; 4 - 6 hourly; Total 72 hours |
| Placebo | DRUG | 4 - 6 hourly; Total 72 hours |
Inclusion Criteria: * Female between 18 and 80 years of age; * Scheduled to undergo an abdominal hysterectomy with or without bilateral salpingo-oophorectomy due to uterine leiomyomas, or dysfunctional uterine bleeding or endometrial hyperplasia; * Anesthesiological and surgical procedures performe...