Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00293020
The ClinicalTrials.gov registry entry for NCT00293020 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 244 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (93% lower). The listed sponsor is BioDelivery Sciences International, which has 17 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
-
Spiritual Care or Psychotherapy Versus Palliative Care Alone in Patients With Non-Curative Malignancies
RECRUITING · Phase 3
-
DOAC - Dosing Options in AntiCoagulation Prophylaxis
RECRUITING · Phase 3
-
Abatacept in Immune Checkpoint Inhibitor Myocarditis
RECRUITING · Phase 3
-
Post-Discharge Risk-Based Management in Patients Undergoing High-Risk Elective Major Cancer Operations (PRS II)
RECRUITING · Phase 3
-
A Randomized Controlled Trial of Inhaled Tranexamic Acid for the Treatment of Pulmonary Hemorrhage in Cancer Patients
RECRUITING · Phase 3
-
Evaluation of a Telehealth Oncofertility Care Intervention in Adolescent and Young Adult Cancer Patients
RECRUITING · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
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.