Long-term Extension Study of BEMA™ Fentanyl

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioDelivery Sciences International
• Treatments: Fentanyl

Criteria

Inclusion Criteria:

1. previously qualified for and participated in study FEN-202 for at least 2 weeks,

2. wish to continue using BEMA Fentanyl for treatment of breakthrough pain episodes, and

3. provide signed informed consent at screening prior to any study procedures.

Exclusion Criteria:

1. they have developed a new medical condition after initial enrollment in FEN-202 which, in the opinion of the investigator, would preclude safe and appropriate use of BEMA Fentanyl or participation in this study, or

2. there is evidence of improper use of the study drug.