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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.

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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

FieldValue
Enrollment Target 319 participants
Start Date 2007-12
Est. Completion 2010-10
Phase Phase 3

Sponsor

INSYS Therapeutics

35 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.