Open-label, Long-term Extension Study for Treatment of Breakthrough Cancer Pain With BEMA™ Fentanyl
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Cancer, Pain
Both
Cancer, Pain
Trial Information
Open-label, Long-term Extension Study for Treatment of Breakthrough Cancer Pain With BEMA™ Fentanyl
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety and tolerability of BEMA Fentanyl (any dose) as demonstrated by the occurrence of drug-related SAEs.
Outcome Time Frame:
Continuous
Safety Issue:
Yes
Principal Investigator
David Blum, MD
Investigator Role:
Study Chair
Investigator Affiliation:
BioDelivery Sciences International
Authority:
United States: Food and Drug Administration
Study ID:
FEN-290
NCT ID:
NCT00696137
Start Date:
June 2008
Completion Date:
July 2009
Related Keywords:
- Cancer
- Pain
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