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NCT00538863 · ClinicalTrials.gov registry record · Phase 3
Long-term Safety and Efficacy Study of Fentanyl Sublingual Spray for the Treatment of Breakthrough Cancer Pain
A Phase 3 study, sponsored by INSYS Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 319
- Enrollment target
NCT00538863: Completed Phase 3 study, sponsored by INSYS Therapeutics.
NCT00538863 is a Phase 3 study that has completed, run by INSYS Therapeutics. The registered enrollment target is 319 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00538863, a Phase 3 study, has completed, sponsored by INSYS Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 319 participants
- Enrollment target
Study 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.
Interventions
- DRUG Fentanyl sublingual spray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 319 participants |
| Start Date | 2007-12 |
| Est. Completion | 2010-10 |
| Phase | Phase 3 |
What the finished NCT00538863 record still lists
NCT00538863 is an interventional study that assigns participants to a tested intervention. The registered 319 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 1 intervention - of which Fentanyl sublingual spray is the first listed.
NCT00538863 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00538863 about?
NCT00538863 is a clinical study titled "Long-term Safety and Efficacy Study of Fentanyl Sublingual Spray for the Treatment of Breakthrough Cancer Pain". 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.
What is the current status of trial NCT00538863?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 319 participants. The study started on 2007-12. Estimated completion is 2010-10.
What interventions are being tested in trial NCT00538863?
The interventions under investigation include: Fentanyl sublingual spray (DRUG).
Who is sponsoring clinical trial NCT00538863?
This trial is sponsored by INSYS Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00538863's enrollment target sits among peer trials
319 1087th of 2000 higher than 914 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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