Pain Clinical Trial
Official title:
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
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.
RATIONALE: One dose of fentanyl sublingual spray may be effective in relieving pain in
opioid-tolerant cancer patients.
PURPOSE: This phase III trial is studying the side effects of fentanyl sublingual spray and
to see how well it works in treating opioid-tolerant cancer patients with or without oral
mucositis.
OBJECTIVES:
Primary
- To compare the absorption/distribution kinetics of a single dose of fentanyl sublingual
spray in opioid-tolerant cancer patients with or without oral mucositis.
- To evaluate the safety and tolerability of this regimen.
OUTLINE: This is a multicenter study.
Patients fast for at least 8 hours before and at least 4 hours after and no water is allowed
for at least 1 hour before and at least 1 hour after study drug administration. Patients
receive a single dose of fentanyl sublingual spray while in an upright position in clinical
care recliners or beds, and remain in an upright posture for at least 4 hours after
administration. Patients are instructed not to swallow for at least 5 minutes after
administration and not to expectorate the drug.
After study drug administration, 10 blood samples are collected over a 12-hour period for
pharmacokinetic and other analyses.
;
Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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