drugset / Trial / NCT01909856

The Efficacy and Safety of Palonosetron in Preventing the Gastrointestinal Reactions Induced by 3-day Highly Emetogenic Chemotherapy

NCT01909856

Phase 2 Completed 92 enrolled Jiangsu Simcere Pharmaceutical Co., Ltd.
RandomizedCrossoverQuadruple-blindPrevention

Summary

This study is to assess the efficacy and safety of palonosetron in preventing the acute and delayed emesis induced by 3-day highly emetogenic chemotherapy. A double-blind, crossover design is used and granisetron is the positive control.

Timeline

Start
2011-10
Primary completion
2014-04
Completion
2014-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Granisetron Other / unclassified 3 mg
Subject Palonosetron Other / unclassified 0.25 mg
Background Cisplatin Other / unclassified 25 mg/m2
Background Dexamethasone Small molecule 10 mg

Indications