CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 319 enrolled
Drug / intervention
Fentanyl sublingual spraydrug
Likely dose
Fentanyl sublingual spray 1600 µgfrom 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.

Search/NCT00538863
NCT00538863Phase 3Completed
CompareCT.gov

Open-label Multi-center Safety Trial of Fentanyl Sublingual Spray (Fentanyl SL Spray) for the Treatment of Breakthrough Cancer Pain

INSYS Therapeutics Inc·interventional·Posted Oct 3, 2007·Updated Oct 11, 2013

In Brief

A Phase 3 clinical trial evaluating Fentanyl sublingual spray for Cancer and Pain. Completed, enrolled 319 participants across 52 sites in 3 countries.

Detailed Summary

The purpose of this study was to assess the 90-day safety of fentanyl sublingual spray for the treatment of breakthrough cancer pain in subjects on around-the-clock opioids for their persistent cancer pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer, Pain
CountriesCanada, India, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 3, 2007
Enrollment StartDec 1, 2007
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 18.7 years ago

Interventions

Fentanyl sublingual spraydrug

Fentanyl sublingual spray in doses of 100, 200, 400, 600, 800, 1200, and 1600 µg