NCT00696137

Long-term Extension Study of BEMA™ Fentanyl

Open-label, Long-term Extension Study for Treatment of Breakthrough Cancer Pain With BEMA™ Fentanyl

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: BioDelivery Sciences International · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Respiratory Depression

Interventions

Type	Name	Description
DRUG	BEMA Fentanyl	buccal soluble film; 200, 400, 600, 800, and 1200 mcg fentanyl; up to 4 times daily

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2008-06-12
• Last updated: 2019-09-24
• Results posted: 2018-12-19