50
Participants
Start Date
January 4, 2016
Primary Completion Date
September 27, 2018
Study Completion Date
January 27, 2021
Fentanyl Sublingual Spray
"Low-dose Fentanyl Goup: 15-25% of the morphine equivalent daily dose (MEDD) sprayed into mouth and under tongue one hour after first Shuttle Walk Test.~High-Dose Fentanyl Group: 35-45% of the morphine equivalent daily dose (MEDD) sprayed into mouth and under tongue one hour after first Shuttle Walk Test."
Shuttle Walk Test
Participants walk back and forth between 2 cones in an indoor hallway for up to 12 minutes. After one hour Fentanyl Spray delivered, then second walk test performed.
Questionnaires
Questionnaire completed about any breathing problems or other symptoms participant may be having at baseline. End of study questionnaire asks which dose level of study drug participant thinks they received. Participant also completes a questionnaire about how study drug may have helped them and how satisfied they are with the study. It should take about 5 minutes to complete the questionnaire.
Mental Ability Tests
After each walk test, participant completes 4 tests of their mental abilities. It should take 15 minutes total to complete these tests.
Phone Call
Thirty days study visit participant called by study staff. This call should last about 10 minutes.
University of Texas MD Anderson Cancer Center, Houston
Collaborators (1)
INSYS Therapeutics Inc
INDUSTRY
M.D. Anderson Cancer Center
OTHER