Long-term Extension Study of BEMA™ Fentanyl

Respiratory Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00696137
• Other study ID #: FEN-290
• Status: Completed
• Phase: Phase 3
• Start date: June 2008
• Est. completion date: July 2009

Study information

• Verified date: September 2019
• Source: BioDelivery Sciences International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Depression
• Respiratory Insufficiency

Intervention

Drug:
• BEMA Fentanyl
buccal soluble film; 200, 400, 600, 800, and 1200 mcg fentanyl; up to 4 times daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BioDelivery Sciences International

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy Was Not Measured in This Study. The Number of Deaths in the Long Term Follow-up Will be Reported.	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.	3 years