Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
RATIONALE: Fentanyl sublingual spray may help relieve breakthrough pain in patients receiving opioids for cancer pain.
PURPOSE: This randomized phase III trial is studying how well fentanyl sublingual spray works in treating breakthrough cancer pain.
Drug: fentanyl sublingual spray
Other: questionnaire administration
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Multi-Center Study to Evaluate the Safety and Efficacy of Fentanyl Sublingual Spray (Fentanyl SL Spray) for the Treatment of Breakthrough Cancer Pain|
- Pain relief by 30 minutes after dosing [ Designated as safety issue: No ]
- Pain relief at various time points [ Designated as safety issue: No ]
- Safety, tolerability, and acceptability [ Designated as safety issue: Yes ]
|Study Start Date:||October 2007|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
- Determine the efficacy and safety of fentanyl sublingual (SL) spray for the treatment of breakthrough cancer pain in patients on around-the-clock opioids for their persistent cancer pain.
- Evaluate the safety of fentanyl SL spray in these opioid-tolerant patients.
- Assess the patient's satisfaction with treatment medication.
OUTLINE: This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual (SL) spray as a treatment for breakthrough cancer pain.
The study medication is administered under the tongue as a simple spray and can be self-administered by patients or assisted by their caregivers. In addition, there is a questionnaire assessing satisfaction with the treatment. Patients are titrated to an effective-dose of fentanyl SL spray in the open-label titration period and then proceed to the double-blind randomized period. Patients are treated for up to a total of 6-7 weeks (including both the open-label titration and the double-blind randomized periods).
|United States, Texas|
|InSys Therapeutics, Incorporated|
|The Woodlands, Texas, United States, 77389|
|Study Chair:||Ramesh Acharya, MD||Insys Therapeutics Inc|