At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 18 enrolled
Drug / intervention
Fentanyl sublingual spraydrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluate Safety and Tolerability and Compare Absorption/Distribution Kinetics of a Single 100 Mcg Dose of Fentanyl Sublingual Spray (Fentanyl SL Spray) in Cancer Subjects With or Without Oral Mucositis
In Brief
A Phase 3 clinical trial evaluating Fentanyl sublingual spray for Mucositis and 2 related conditions. Completed, enrolled 18 participants across 1 site.
Detailed Summary
This was an open-label, single-dose study to assess the safety, tolerability, and absorption/distribution kinetics of a single 100 µg dose of fentanyl sublingual spray in opioid-tolerant cancer subjects, with or without oral mucositis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2009
Enrollment StartOct 2009
Primary CompletionOct 2010
TodayJul 2026
First PostedAug 11, 2009
Enrollment StartOct 1, 2009
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 16.9 years ago
Interventions
Fentanyl sublingual spraydrug
Fentanyl was supplied in single-dose glass vials assembled into a delivery device to be used as a sublingual spray.