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NCT00956254 · ClinicalTrials.gov registry record · Phase 3
Fentanyl Sublingual Spray in Treating Opioid-tolerant Cancer Patients With or Without Oral Mucositis
A Phase 3 study, sponsored by INSYS Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 18
- Enrollment target
NCT00956254 is a Phase 3 study that has completed, run by INSYS Therapeutics. The registered enrollment target is 18 participants.
The verdict
NCT00956254, a Phase 3 study, has completed, sponsored by INSYS Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 18 participants
- Enrollment target
Study Summary
This was an open-label, single-dose study to assess the safety, tolerability, and absorption/distribution kinetics of a single 100 µg dose of fentanyl sublingual spray in opioid-tolerant cancer subjects, with or without oral mucositis.
Interventions
- DRUG Fentanyl sublingual spray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2009-10 |
| Est. Completion | 2010-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00956254
The ClinicalTrials.gov registry entry for NCT00956254 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 18 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.
NCT00956254 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00956254 about?
NCT00956254 is a clinical study titled "Fentanyl Sublingual Spray in Treating Opioid-tolerant Cancer Patients With or Without Oral Mucositis". This was an open-label, single-dose study to assess the safety, tolerability, and absorption/distribution kinetics of a single 100 µg dose of fentanyl sublingual spray in opioid-tolerant cancer subjects, with or without oral mucositis.
What is the current status of trial NCT00956254?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 18 participants. The study started on 2009-10. Estimated completion is 2010-10.
What interventions are being tested in trial NCT00956254?
The interventions under investigation include: Fentanyl sublingual spray (DRUG).
Who is sponsoring clinical trial NCT00956254?
This trial is sponsored by INSYS Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov.
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