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NCT00293020 · ClinicalTrials.gov registry record · Phase 3
Study of the Safety of BEMA™ Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy
A Phase 3 study of Cancer and Pain, sponsored by BioDelivery Sciences International.
- Completed
- Registry status
- Phase 3
- Development phase
- 244
- Enrollment target
- 1
- Study location
NCT00293020: Completed Phase 3 study of Cancer and Pain, sponsored by BioDelivery Sciences International.
NCT00293020 is a Phase 3 study of Cancer and Pain that has completed, run by BioDelivery Sciences International. The registered enrollment target is 244 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00293020, a Phase 3 study of Cancer and Pain, has completed, sponsored by BioDelivery Sciences International.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 244 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the safety of BEMA fentanyl 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. BioDelivery Sciences International, Inc. (BDSI) has developed BEMA (BioErodible MucoAdhesive) fentanyl, an alternative product to OTFC that does not require the subject to continuously paint the inside of the mouth with the dosage form. The BDSI product is a small disc that is placed against the mucosal membrane inside the mouth. The mucoadhesive polymers in the disc readily adhere to the mucosal membrane (within 5 seconds) when moistened. The components of the disc are water soluble, so the entire dosage form dissolves within 30 minutes of application.
Primary Outcome
After the first dose of BEMA Fentanyl, all adverse events were recorded and summarized.
Interventions
- DRUG BEMA Fentanyl
Study Locations (1)
Texas
- ResearchPoint - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 244 participants |
| Start Date | 2006-02 |
| Est. Completion | 2008-06 |
| Phase | Phase 3 |
What the finished NCT00293020 record still lists
NCT00293020 is an interventional study that assigns participants to a tested intervention. The registered 244 participants enrollment target is mid-sized for trials with a published cap, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with Cancer appearing as the primary indexed condition, and to 1 intervention - of which BEMA Fentanyl is the first listed.
NCT00293020 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00293020 about?
NCT00293020 is a clinical study titled "Study of the Safety of BEMA™ Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy". The purpose of this study is to evaluate the safety of BEMA fentanyl 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 sleepine...
What is the current status of trial NCT00293020?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 244 participants. The study started on 2006-02. Estimated completion is 2008-06.
What conditions does trial NCT00293020 study?
This clinical trial studies the following conditions: Cancer, Pain.
What interventions are being tested in trial NCT00293020?
The interventions under investigation include: BEMA Fentanyl (DRUG).
Who is sponsoring clinical trial NCT00293020?
This trial is sponsored by BioDelivery Sciences International, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00293020 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00293020's enrollment target sits among peer trials
244 210th of 615 higher than 406 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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