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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 is a Phase 3 study that has completed, run by INSYS Therapeutics. The registered enrollment target is 130 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00538850
The ClinicalTrials.gov registry entry for NCT00538850 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is INSYS Therapeutics, which has 35 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00538850 reports 0 study locations.
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.
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