drugset / Trial / NCT01429051

A Clinical Trial With Intranasal Fentanyl in Cancer Patients With Breakthrough Pain

NCT01429051

Phase 3 Completed 46 enrolled Takeda
NaSingle-groupDouble-blindTreatment

Summary

The aim of this clinical trial was to demonstrate the efficacy of a 400 μg dose strength of intranasal fentanyl spray (INFS, Instanyl®) and to evaluate the safety and to establish long term tolerability of treatment with INFS doses of 50, 100, 200 and 400 μg.

Timeline

Start
2011-08
Primary completion
2013-01
Completion
2013-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Fentanyl Other / unclassified 50 ug Intranasal
Subject Fentanyl Other / unclassified 100 ug Intranasal
Subject Fentanyl Other / unclassified 200 ug Intranasal
Subject Fentanyl Other / unclassified 400 ug Intranasal

Indications