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NCT00538850 · ClinicalTrials.gov registry record · Phase 3
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
A Phase 3 study, sponsored by INSYS Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 130
- Enrollment target
NCT00538850: Completed Phase 3 study, sponsored by INSYS Therapeutics.
NCT00538850 is a Phase 3 study that has completed, run by INSYS Therapeutics. The registered enrollment target is 130 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00538850, a Phase 3 study, has completed, sponsored by INSYS Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 130 participants
- Enrollment target
Study Summary
This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual 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. Patients are titrated to an effective-dose of fentanyl sublingual spray in the open-label titration period and then proceed to the double-blind randomized period where they randomly receive 7 treatments with fentanyl sublingual spray and 3 treatments with placebo. Patients are treated for up to a total of 6-7 weeks (including both the open-label titration and the double-blind randomized periods).
Primary Outcome
Pain intensity was assessed by the participant using a 0-100 mm visual analog scale where 0 represented "no pain" and 100 represented "worst possible pain" at 0 (baseline, beginning of the pain episode), 5, 10, 15, and 30 minutes after each dose of study medication during each breakthrough pain episode. The pain intensity difference was defined as the difference in pain intensity at the various time points versus time 0 (baseline). SPID30 was calculated as the time-weighted sum of the PID scores
Interventions
- DRUG Placebo
- DRUG Fentanyl sublingual spray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2007-10 |
| Est. Completion | 2010-10 |
| Phase | Phase 3 |
What the finished NCT00538850 record still lists
NCT00538850 is an interventional study that assigns participants to a tested intervention. The registered 130 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 (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00538850 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00538850 about?
NCT00538850 is a clinical study titled "Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain". This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual 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 ...
What is the current status of trial NCT00538850?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 130 participants. The study started on 2007-10. Estimated completion is 2010-10.
What interventions are being tested in trial NCT00538850?
The interventions under investigation include: Placebo (DRUG), Fentanyl sublingual spray (DRUG).
Who is sponsoring clinical trial NCT00538850?
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 NCT00538850's enrollment target sits among peer trials
130 1594th of 2000 higher than 404 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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