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Post-operative administration of ipamorelin is expected to reduce time to recovery of Gastrointestinal (GI) function in patients who have undergone partial small and/or large bowel resection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.03 mg/kg BID | Experimental | Ipamorelin 0.03 mg/kg, BID (2 investigational drug infusions and 1 placebo infusion) |
|
| 0.06 mg/kg BID | Experimental | Ipamorelin 0.06 mg/kg, BID (2 investigational drug infusions and 1 placebo infusion) |
|
| 0.06 mg/kg TID | Experimental | Ipamorelin 0.06 mg/kg, TID (3 investigational drug infusions) |
|
| Placebo | Placebo Comparator | Matching placebo, TID (3 placebo infusions) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline Solution for Injection | Drug | Intravenous (IV) |
| |
| Ipamorelin |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery of Gastrointestinal (GI) Function | To assess the efficacy of three repeated dose levels of ipamorelin vs. placebo | Up to 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Ancillary GI Functions | To investigate the effect of ipamorelin on ancillary efficacy measures of GI function and recovery | Up to 10 days or until hospital discharge |
| Number of Subjects with Adverse Events as a Measure of Safety and Tolerability |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florence | Alabama | United States | ||||
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| Drug |
Intravenous (IV) |
|
To investigate the safety and tolerability of ipamorelin laboratory and clinical parameters, incidence of adverse events, until hospital discharge, 14-day outpatient follow-up visit, or until resolution of adverse events
| 14 day outpatient follow-up visit |
| Sheffield |
| Alabama |
| United States |
| Fountain Valley | California | United States |
| Glendale | California | United States |
| Laguna Hills | California | United States |
| Los Angeles | California | United States |
| Orange | California | United States |
| San Francisco | California | United States |
| Aurora | Colorado | United States |
| Aventura | Florida | United States |
| Inverness | Florida | United States |
| Miami | Florida | United States |
| Orlando | Florida | United States |
| Pensacola | Florida | United States |
| Sarasota | Florida | United States |
| Tampa | Florida | United States |
| Weston | Florida | United States |
| Atlanta | Georgia | United States |
| Chicago | Illinois | United States |
| Highland Park | Illinois | United States |
| Indianapolis | Indiana | United States |
| Des Moines | Iowa | United States |
| Iowa City | Iowa | United States |
| Kansas City | Kansas | United States |
| New Orleans | Louisiana | United States |
| Springfield | Massachusetts | United States |
| Flint | Michigan | United States |
| Royal Oak | Michigan | United States |
| Troy | Michigan | United States |
| Jackson | Mississippi | United States |
| St Louis | Missouri | United States |
| Stony Brook | New York | United States |
| Chapel Hill | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Columbus | Ohio | United States |
| Hershey | Pennsylvania | United States |
| Pittsburgh | Pennsylvania | United States |
| Memphis | Tennessee | United States |
| Nashville | Tennessee | United States |
| Houston | Texas | United States |
| Nassau Bay | Texas | United States |
| Burlington | Vermont | United States |
| Bellevue | Washington | United States |
| Milwaukee | Wisconsin | United States |
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D007267 | Injections |
| C114611 | ipamorelin |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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