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NCT00293033 · ClinicalTrials.gov registry record · Phase 3
Study of BEMA™ Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects
A Phase 3 study, sponsored by BioDelivery Sciences International.
- Completed
- Registry status
- Phase 3
- Development phase
- 152
- Enrollment target
NCT00293033 is a Phase 3 study that has completed, run by BioDelivery Sciences International. The registered enrollment target is 152 participants.
The verdict
NCT00293033, a Phase 3 study, has completed, sponsored by BioDelivery Sciences International.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 152 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of BEMA Fentanyl (Onsolis) at any dose in the management of breakthrough pain in cancer subjects on background opioid therapy. The standard of care for these breakthrough pain episodes is a rapid onset, short acting analgesic with minimal associated sleepiness. Oral morphine, oxycodone and hydromorphone are routinely used, but because of slow and variable oral absorption, the pain control is not the best with these products. Oral transmucosal fentanyl citrate (OTFC) has been used successfully in treating breakthrough pain episodes associated with cancer. OTFC is a lozenge of fentanyl on a stick and is administered by continuously swabbing the interior of the subject's mouth until the product is dissolved (approximately 15 to 30 minutes). The buccal route of administration avoids the delay and variability associated with oral absorption.
Interventions
- DRUG Placebo
- DRUG BEMA™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2006-02 |
| Est. Completion | 2007-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00293033
The ClinicalTrials.gov registry entry for NCT00293033 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 152 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioDelivery Sciences International, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00293033 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00293033 about?
NCT00293033 is a clinical study titled "Study of BEMA™ Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects". The purpose of this study is to evaluate the efficacy of BEMA Fentanyl (Onsolis) at any dose in the management of breakthrough pain in cancer subjects on background opioid therapy. The standard of care for these breakthrough pain episodes is a rapid onset, short acting analgesic with minimal associa...
What is the current status of trial NCT00293033?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 152 participants. The study started on 2006-02. Estimated completion is 2007-04.
What interventions are being tested in trial NCT00293033?
The interventions under investigation include: Placebo (DRUG), BEMA™ (DRUG).
Who is sponsoring clinical trial NCT00293033?
This trial is sponsored by BioDelivery Sciences International, which has 17 total clinical trials registered on ClinicalTrials.gov.
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