Long-term Extension Study of BEMA™ Fentanyl

Status Completed

Clinical Trial Summary

This study is designed to provide continued access to BEMA Fentanyl for those subjects who previously participated in FEN-202 and who wish to continue using BEMA Fentanyl for the treatment of their breakthrough cancer pain.

Clinical Trial Description

This was an open label, long-term, extension study designed to provide continued access to EMA Fentanyl to those patients with breakthrough cancer pain who were treated for at least 2 weeks in FEN-202, the long term safety study used for worldwide registration. Patients were followed in an outpatient setting. Use of BEMA Fentanyl and occurrence of serious adverse events (SAEs) were monitored. Throughout the study, all patients continued their background opioid regimen and were permitted to use their rescue medication if adequate pain relief was not realized within 30 minutes following application of BEMA Fentanyl. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00696137
Study type	Interventional
Source	BioDelivery Sciences International
Contact
Status	Completed
Phase	Phase 3
Start date	June 2008
Completion date	July 2009

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