Sublingual Fentanyl for the Management of Breakthrough Pain

PHASE2TerminatedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

February 2, 2016

Primary Completion Date

November 4, 2019

Study Completion Date

November 4, 2019

Conditions
Advanced Cancers
Interventions
DRUG

Fentanyl Sublingual Spray (FSS)

"Stage 1: First Pain Episode - Single dose of breakthrough opioid given from existing PCA pump equivalent to 10% of their MEDD.~Second Pain Episode - Single dose of FSS equivalent to 16-32% of MEDD. If not effective at 30 minutes, participant repeats same dose one more time (with a cap of 1600 mcg total; i.e. dose given 30 minutes ago + dose now = 1600 mcg maximum.~Third Pain Episode (at least 4 hours after second episode) - Participant required 2 breakthrough FSS doses for the last episode of breakthrough pain, or if the effective dose has not been identified, he/she will double the last administered dose. If breakthrough pain not effective at 30 minutes, participant repeats same dose one more time (with a cap of 1600 mcg total; i.e. dose given 30 minutes ago + dose now = 1600 mcg maximum).~Stage 2: If FSS successful in hospital, upon discharge, FSS used as first choice of pain medication instead of oral pain medication for pain for up to 4 weeks."

BEHAVIORAL

Questionnaires

Symptom questionnaire completed at baseline and after last dose of FSS while hospitalized. After Day 28, questionnaire completed over the phone about participant's opinion of research study.

BEHAVIORAL

Mental Ability Tests

Mental ability tests given while hospitalized 30 minutes after first dose of current pain medication, and 30 minutes after each FSS dose.

BEHAVIORAL

Study Diary

Participants given study diary to document pain level, how many times FSS used, and any side effects experienced each day.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

INSYS Therapeutics Inc

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER