Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study, sponsored by BioDelivery Sciences International.
NCT00293033 is a Phase 3 study that has completed, run by BioDelivery Sciences International. The registered enrollment target is 152 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Pain intensity (using an 11-point \[0 = no pain to 10 = worst pain\] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of
Interventions
- DRUG Placebo
- DRUG BEMA™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2006-02 |
| Est. Completion | 2007-04 |
| Phase | Phase 3 |
What the finished NCT00293033 record still lists
NCT00293033 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00293033 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00293033's enrollment target sits among peer trials
152 1513th of 2000 higher than 484 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03328078 · 152 participants · Phase 1
CA-4948-101: Open-Label, Dose Escalation and Expansion Trial of Emavusertib (CA-4948) in Relapsed or Refractory Primary Central Nervous System Lymphoma (R/R PCNSL)
- NCT04458532 · 152 participants · NA
Exercise Therapy to Improve Cardiovascular Health in Post-Menopausal Women After Treatment for Early Stage Breast Cancer
- NCT04858334 · 152 participants · Phase 2
APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation
- NCT04993859 · 152 participants
Impact of Chemotherapy on Urinary Biomarkers and Non-Invasive Urodynamics in Children
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia