Open-label Multi-center Safety Trial of Fentanyl Sublingual Spray (Fentanyl SL Spray) for the Treatment of Breakthrough Cancer Pain
This is an open-label multi-center study of the safety of Fentanyl SL Spray as a treatment
for breakthrough cancer pain. The study medication is administered under the tongue as a
simple spray and can be self-administered by subjects or assisted by their caregivers. In
addition, there is a questionnaire assessing satisfaction with the treatment. A total of
300 opioid-treated subjects will be enrolled.
Subjects may enter this study by one of two routes:
- De novo subjects who meet the inclusion criteria and none of the exclusion criteria at
the Screening Visit will enroll onto the study at the Open-label Titration Period;
- All subjects who have successfully completed the Double-blind Randomization Period and
the Final Visit of Protocol INS-05-001 will be eligible to enter this study as an
open-label extension study at the Open label Maintenance Period.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
The primary objective is to assess the safety of Fentanyl SL Spray in subjects on efficacious doses of Fentanyl SL Spray
90 days
No
Larry Dillaha, MD
Study Director
Chief Medical Officer, Insys Therapeutics Inc
United States: Food and Drug Administration
INS-06-007
NCT00538863
December 2007
October 2010
Name | Location |
---|---|
Multiple sites | United States, California 00000 |