Long-term Extension Study of BEMA™ Fentanyl

Phase 3

Completed

• Conditions: Respiratory Depression
• Interventions: Drug: BEMA Fentanyl

• Registration Number: NCT00696137
• Lead Sponsor: BioDelivery Sciences International

Brief 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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-10
• Study First Submitted QC: 2008-06-10
• Study First Posted: 2008-06-12
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Results First Submitted: 2018-06-07
• Results First Submitted QC: 2018-12-17
• Results First Posted: 2018-12-19
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-12
• Last Update Posted: 2019-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BEMA Fentanyl	BEMA Fentanyl	BEMA Fentanyl

Primary Outcome Measures

Name	Time	Method
Efficacy Was Not Measured in This Study. The Number of Deaths in the Long Term Follow-up Will be Reported.	3 years	Efficacy was not measured in this study as the intention was to evaluate long term safety in this population. The number of deaths in the long term follow-up will be reported.