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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00890682 | Study of Postoperative Analgesia in Bunionectomy | PHASE3 | COMPLETED | 193 | — | — | Apr 1, 2009 | Nov 1, 2009 | Aug 5, 2013 | 1 | United States |
The AUC of the NRS-R pain intensity scores from time 0 through 24 hours The subject was to rest for at least 5 minutes before responding to the following question, "On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain are you having right now?"
| Arm | Type | Description |
|---|---|---|
| Sky0402 | EXPERIMENTAL | Injection of Study Drug |
| Placebo | PLACEBO_COMPARATOR | Injection of study drug |
| Name | Type | Description |
|---|---|---|
| SKY0402 | DRUG | Local infiltration of 8cc SKY0402 |
| Placebo | DRUG | Local infiltration of 8cc Placebo |
Inclusion Criteria: * Age ≥ 18 years at the Screening visit * Scheduled to undergo primary unilateral first metatarsal osteotomy without hammertoe * Female subjects must be surgically sterile or at least two years menopausal, or using an acceptable method of birth control. If of childbearing potent...