TerminatedPhase 2

Sublingual Fentanyl for the Management of Breakthrough Pain

United States6 participantsStarted 2016-02-02

Plain-language summary

The goal of this clinical research study is to learn if an investigational dose of fentanyl sublingual spray (FSS) can help to control pain in patients with advanced cancer when given in an outpatient and inpatient setting.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients with advanced cancer (locally advanced, metastatic, recurrent and/or incurable cancer).
✓. Opioid tolerant, taking daily doses of strong opioid pain medication in the past 1 week.
✓. On strong opioid intravenous continuous infusion MEDD \>=70 mg/day at the time of enrollment.
✓. Inpatient at MD Anderson seen by palliative care team.
✓. Background cancer pain that is \<=3/10 in the last 24 hours.
✓. Breakthrough cancer pain that is \>=4/10 in the last 24 hours.
✓. Stable pain control defined as rescue doses \<=6 in last 24 hours.
✓. Age \>=18

Exclusion criteria

✕. Memorial Delirium Assessment Scale \>13/30
✕. History of opioid abuse
✕. CAGE positivity (\>=2/4)
✕. Allergy to fentanyl
✕. Grade 2 or higher oral mucositis
✕. Unable/unwilling to sign consent

What they're measuring

Effective Dose of Fentanyl Sublingual Spray (FSS)

Timeframe: Up to 1 months after discharge from the hospital

Trial details

NCT IDNCT02514252

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-11-04

Results submitted2021-04-27

View on ClinicalTrials.gov More Advanced Cancers trials