Long-term Extension Study of BEMA™ Fentanyl
Open-label, Long-term Extension Study for Treatment of Breakthrough Cancer Pain With BEMA™ Fentanyl
1 other identifier
interventional
5
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2008
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 10, 2008
CompletedFirst Posted
Study publicly available on registry
June 12, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
December 19, 2018
CompletedSeptember 24, 2019
September 1, 2019
1.1 years
June 10, 2008
June 7, 2018
September 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
BEMA Fentanyl
EXPERIMENTALBEMA Fentanyl
Interventions
buccal soluble film; 200, 400, 600, 800, and 1200 mcg fentanyl; up to 4 times daily
Eligibility Criteria
You may qualify if:
- previously qualified for and participated in study FEN-202 for at least 2 weeks,
- wish to continue using BEMA Fentanyl for treatment of breakthrough pain episodes, and
- provide signed informed consent at screening prior to any study procedures.
You may not qualify if:
- 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
- there is evidence of improper use of the study drug.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tim Warneke
- Organization
- BDSI
Study Officials
- STUDY CHAIR
David Blum, MD
BioDelivery Sciences International
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2008
First Posted
June 12, 2008
Study Start
June 1, 2008
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
September 24, 2019
Results First Posted
December 19, 2018
Record last verified: 2019-09