35
Participants
Start Date
June 11, 2013
Primary Completion Date
November 25, 2019
Study Completion Date
November 25, 2019
Fentanyl Pectin Nasal Spray
Fentanyl pectin nasal (FPNS) dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) administered intranasally 20 minutes before the second 6-minute walk test. Same dose repeated at least 30 minutes after the first dose and 20 minutes prior to the third and final 6 minute walk test.
Placebo Nasal Spray
Placebo nasal spray administered intranasally 20 minutes before the second 6-minute walk test. Same dose repeated at least 30 minutes after the first dose and 20 minutes prior to the third and final 6 minute walk test.
Walk Test
Walk test administered before first dose of drug/placebo nasal spray. Participant will rest for 30 minutes after walk test. Drug/placebo nasal spray administered, then participant will wait 20 minutes before repeating second 6 minute walk test. After second walk test, participant will rest for 30 minutes. Drug/placebo nasal spray administered for second time, then participant will wait for 20 minutes. Walk test administered again for 6 minutes.
Questionnaires
Questionnaires completed at baseline, before each walk test, and at end of final walk test.
Mental Ability Tests
Four mental ability tests administered after each walk test to include finger tapping, simple mathematics questions, recall of numbers, and recall of objects.
University of Texas MD Anderson Cancer Center, Houston
Collaborators (1)
Depomed
INDUSTRY
M.D. Anderson Cancer Center
OTHER