PainPhase 3NCT00293020
Study of the Safety of BEMA™ Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy
A Phase 3 study testing BEMA Fentanyl in people with Pain and Cancer, run by BioDelivery Sciences International at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- BEMA Fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Jun 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant and non-lactating female. A female of child-bearing potential is eligible to participate in this study if she is using an acceptable method of birth control.
- 18 years or older
- Patient must have pain associated with cancer or cancer treatment
- Patient must be on a stable current regimen of oral opioids equivalent to 60 - 1000 mg/day of oral morphine or 50 - 300 µg/hr of transdermal fentanyl (e.g. oxycodone 30 mg, methadone 20 mg, and hydromorphone 7.5 mg)
- Regularly experience 1 - 4 breakthrough pain episodes per day that require additional opioids for pain control
- At least partial relief of breakthrough pain by use of opioid therapy
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- Subject must be able to self-administer the study medication correctly.
- Subject must be willing and able to complete the electronic diary card with each pain episode.
- Signed consent must be obtained at screening prior to any procedures being performed.
Who cannot join
- Psychiatric/cognitive or neurological impairment that would limit the subject's ability to understand or complete the diary
- Cardiopulmonary disease that, in the opinion of the investigator, would significantly increase the risk of respiratory depression
- Recent history or current evidence of alcohol or other drug substance (licit or illicit) abuse
- Rapidly escalating pain that the investigator believes may require an increase in the dosage of background pain medication during the study
- Moderate (Grade 3) to severe (Grade 4) mucositis (subjects with less than moderate mucositis are permitted and must be instructed to not apply the BEMA disc at a site of inflammation)
- Strontium 89 therapy within the previous 6 months
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- Any other therapy prior to the study that the investigator considers could alter pain or the response to pain medication.
- Use of an investigational drug within 4 weeks preceding this study • History of hypersensitivity or intolerance to fentanyl
- Regularly more than 4 episodes per day
- ECOG performance status of 4 or 5
- Subject is pregnant, actively trying to become pregnant, breast feeding or not using adequate contraceptive measures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Long-term Treatment Evaluation 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 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.
- Being tested
- BEMA Fentanyl
- Keywords
- Breakthrough Pain in Cancer Patients
- Medical subject headings
- Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEMA FentanylDrug
Also called bioerodible mucoadhesive system
buccal soluble film; 200, 400, 600, 800, 1200 mcg fentanyl; up to 4 times daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | BEMA Fentanyl Receives: Drug: BEMA Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events.
After the first dose of BEMA Fentanyl, all adverse events were recorded and summarized.
Measured: Participants were followed for the duration of the study, an average of 126 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioDelivery Sciences International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Blum, MD, Study chair, BioDelivery Sciences International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293020
- Sponsor's protocol ID
- FEN-202
- Status last verified
- Sep 2012
- First submitted
- 15 Feb 2006
- Last updated
- 5 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Long-term Treatment Evaluation of the Safety of BEMA™ Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy
- ClinicalTrials.gov ID
- NCT00293020
- Acronym / sponsor ID
- FEN-202
- Keywords
- Breakthrough Pain in Cancer Patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- BioDelivery Sciences InternationalIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 17 Feb 2006 (estimated)
- Results
- Posted 5 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: BEMA FentanylBEMA Fentanyl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or non-pregnant and non-lactating female. A female of child-bearing potential is eligible to participate in this study if she is using an acceptable method of birth control.
- 18 years or older
- Patient must have pain associated with cancer or cancer treatment
- Patient must be on a stable current regimen of oral opioids equivalent to 60 - 1000 mg/day of oral morphine or 50 - 300 µg/hr of transdermal fentanyl (e.g. oxycodone 30 mg, methadone 20 mg, and hydromorphone 7.5 mg)
- Regularly experience 1 - 4 breakthrough pain episodes per day that require additional opioids for pain control
Key exclusion criteria (11 listed)
- Psychiatric/cognitive or neurological impairment that would limit the subject's ability to understand or complete the diary
- Cardiopulmonary disease that, in the opinion of the investigator, would significantly increase the risk of respiratory depression
- Recent history or current evidence of alcohol or other drug substance (licit or illicit) abuse
- Rapidly escalating pain that the investigator believes may require an increase in the dosage of background pain medication during the study
- Moderate (Grade 3) to severe (Grade 4) mucositis (subjects with less than moderate mucositis are permitted and must be instructed to not apply the BEMA disc at a site of inflammation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BEMA FentanylAlso: bioerodible mucoadhesive systembuccal soluble film; 200, 400, 600, 800, 1200 mcg fentanyl; up to 4 times daily | Drug | 1 |
Primary outcome
Percentage of Participants With Adverse Events.
Time frame: Participants were followed for the duration of the study, an average of 126 days
After the first dose of BEMA Fentanyl, all adverse events were recorded and summarized.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Blum, MD study chair
BioDelivery Sciences International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BEMA Fentanyl in people with Pain and Cancer, run by BioDelivery Sciences International at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Adverse Events. (time frame: Participants were followed for the duration of the study, an average of 126 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2012.