NCT01710982

Study to Evaluate the Safety of Post-Operative TZP-101 (IV Ulimorelin) After Partial Bowel Resection

A Multicentre, Randomised, Double-blind, Placebo-Controlled Study to Evaluate the Safety of TZP-101 (IV Ulimorelin) Administered Post-Operatively in Patients Who Have Undergone Partial Bowel Resection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Norgine · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Postoperative Ileus

Interventions

Type	Name	Description
DRUG	TZP-101
OTHER	Placebo

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2012-10-19
• Last updated: 2024-09-19