The purpose of this study is to determine whether TZP-101 is effective in the management of post operative ileus in subjects undergoing major open abdominal surgery (i.e. partial large bowel resection).
Subjects will be randomized according to an adaptive randomization procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
267
Time to recovery of gastrointestinal function as defined by the time to first bowel movement.
Time frame: 7 days of dosing plus 7 days after administration of last dose
time to tolerance of first solid food
Time frame: 7 days post administration of last dose
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80 micrograms/kg IV 2ml/minute for 30 minutes
160 micrograms/kg IV 2ml/minute over 30 minutes
320 micrograms/kg IV 2ml/minute for 30 minutes
480 micrograms/kg IV 2ml/minute over 30 minutes
600 micrograms/kg IV 2ml/minute for 30 minutes
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