A study to evaluate the safety of TZP-101 in comparison with placebo when administered post-operatively in patients who have undergone partial bowel resection.
This was a multicenter, multinational, randomized, parallel, double-blind, placebo-controlled study to evaluate the safety of TZP-101 administered post operatively to male and female patients aged 18-80 years of age who had undergone partial bowel resection. It was anticipated that 330 patients would be dosed with once-daily IV administration of 480 mcg/kg TZP-101 or placebo on a 2:1 ratio. An approximately 7% loss of eligible patients between randomization and dosing was expected, therefore it was anticipated that approximately 355 patients would be randomized onto the trial. This study consisted of a screening period, an in-patient treatment period and a follow-up phone call. The follow-up phone call was to be performed 14 days (+/- 2 days) after the last study drug administration and a follow-up clinic visit 32 days after the last study drug administration. The overall study duration for each patient was not expected to exceed 63 days. Dosing was to be once daily, commencing within one hour following surgery and continuing every 24hrs (+/- 2hrs) until the first BM, up to a maximum of 7 doses for all patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
27
Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability
To evaluate the safety of TZP-101 in comparison with placebo when administered post-operatively in patients who have undergone partial bowel resection.
Time frame: 32 days post-dosing
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