NCT01543451

Proof-of-Concept Study in Cancer Patients to Assess Efficacy of Elsiglutide in Preventing Chemotherapy-Induced Diarrhea

Phase II, Double-blind, Randomized, Two-stage, Placebo-controlled Proof of Concept Study in Colorectal Cancer Patients Receiving 5-FU Based Chemotherapy to Assess the Efficacy of Elsiglutide (ZP1846)Administered s.c. in the Prevention of Chemotherapy Induced Diarrhea(CID)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Helsinn Healthcare SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study will be to obtain data on the efficacy of elsiglutide in preventing Chemotherapy Induced Diarrhea (CID) in patients with colorectal cancer receiving 5-FU based chemotherapy (FOLFOX4 or FOLFIRI regimen) in comparison to placebo.

Conditions

• Diarrhea

Interventions

Type	Name	Description
DRUG	Elsiglutide	24 mg administered s.c. once daily for 4 consecutive days from Day 1 chemotherapy
DRUG	Placebo	24 mg administered s.c. once daily for 4 consecutive days from Day 1 chemotherapy

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-01-01
• Completion: 2013-10-01
• First posted: 2012-03-05
• Last updated: 2014-03-26

Locations

21 sites across 4 countries: Bulgaria, Hungary, Romania, Russia