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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00231777 | A Study to Examine the Safety and Tolerability of MK0517 for the Prevention of Post-Operative Nausea and Vomiting (0517-015) | PHASE3 | COMPLETED | 216 | — | — | Jul 1, 2005 | Nov 1, 2005 | Aug 19, 2015 | - | — |
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | 40 mg MK0517 IV |
| 2 | ACTIVE_COMPARATOR | 4 mg ondansetron IV |
| Name | Type | Description |
|---|---|---|
| Comparator: MK0517 | DRUG | a single administration of 40 mg MK0517 by IV immediately prior to surgery |
| Comparator: ondansetron | DRUG | a single administration of 4 mg ondansetron by IV immediately prior to surgery |
Inclusion Criteria: * Open abdominal surgery requiring 24 hour hospital stay * General anesthesia * Post-operative opioids * ASA status of I-III Exclusion Criteria: * Patient exhibits evidence of any clinically significant respiratory, metabolic, hepatic, renal dysfunction, or cardiovascular cond...