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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00528970 | A Study Evaluating Intravenous (IV) MOA-728 for the Treatment of Postoperative Ileus (POI) in Participants After Ventral Hernia Repair | PHASE3 | COMPLETED | 374 | — | — | Oct 17, 2007 | Feb 5, 2008 | Sep 4, 2019 | 106 | United States, Australia +9 |
Time to first bowel movement was measured from the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). Time of the first bowel movement was recorded on the electronic case report form (eCRF). The first bowel movement was defined as a normal stool for a postoperative participant based on the clinical judgment of the investigator or designee. Analysis was performed by Kaplan-Meier estimate. Participants who had a bowel movement but were readmitted to the hospital within 1 week after discharge with a diagnosis of postoperative ileus (POI) were considered censored at the time of the first bowel movement as if the bowel movement had not occurred.
| Arm | Type | Description |
|---|---|---|
| MOA-728 12 mg | EXPERIMENTAL | Participants will receive methylnaltrexone (MOA-728) 12 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug will be administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple is placed in the participant). Dose administration will be continued for a maximum of 10 days. |
| MOA-728 24 mg | EXPERIMENTAL | Participants will receive MOA-728 24 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug will be administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple is placed in the participant). Dose administration will be continued for a maximum of 10 days. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matching to MOA-728 as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug will be administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple is placed in the participant). Dose administration will be continued for a maximum of 10 days. |
| Name | Type | Description |
|---|---|---|
| MOA-728 | DRUG | MOA-728 will be administered per the dose and schedule specified in the arm. |
| Placebo | DRUG | Placebo matching to MOA-728 will be administered per the schedule specified in the arm. |
Inclusion Criteria: * Males and females, ages 18 and older. * Scheduled for ventral wall hernia repair with general anesthesia. * Meets the American Society of Anesthesiologists physical status I, II, or III. Exclusion Criteria: * Received investigational drug or procedure within 30 days of rando...