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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
320
Intravenous (IV)
Intravenous (IV)
Recovery of Gastrointestinal (GI) Function
To assess the efficacy of three repeated dose levels of ipamorelin vs. placebo
Time frame: Up to 10 days
Ancillary GI Functions
To investigate the effect of ipamorelin on ancillary efficacy measures of GI function and recovery
Time frame: Up to 10 days or until hospital discharge
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
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
Time frame: 14 day outpatient follow-up visit
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Florence, Alabama, United States
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Sheffield, Alabama, United States
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Fountain Valley, California, United States
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Glendale, California, United States
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Laguna Hills, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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San Francisco, California, United States
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Aurora, Colorado, United States
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Aventura, Florida, United States
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