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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 is a Phase 3 study that has completed, run by INSYS Therapeutics. The registered enrollment target is 319 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00538863
The ClinicalTrials.gov registry entry for NCT00538863 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 319 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 1 intervention - of which Fentanyl sublingual spray is the first listed.
NCT00538863 reports 0 study locations.
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.
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