Respiratory DepressionPhase 3NCT00696137

Long-term Extension Study of BEMA™ Fentanyl

A Phase 3 study testing BEMA Fentanyl in people with Respiratory Depression, run by BioDelivery Sciences International.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is designed to provide continued access to BEMA Fentanyl for those subjects who previously participated in FEN-202 and who wish to continue using BEMA Fentanyl for the treatment of their breakthrough cancer pain. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Respiratory Depression
What is being tested?: BEMA Fentanyl
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: No sites listed yet
Study dates: Jun 2008to Jul 2009
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

previously qualified for and participated in study FEN-202 for at least 2 weeks,
wish to continue using BEMA Fentanyl for treatment of breakthrough pain episodes, and
provide signed informed consent at screening prior to any study procedures.

Who cannot join

they have developed a new medical condition after initial enrollment in FEN-202 which, in the opinion of the investigator, would preclude safe and appropriate use of BEMA Fentanyl or participation in this study, or
there is evidence of improper use of the study drug.

About this study

Official title: Open-label, Long-term Extension Study for Treatment of Breakthrough Cancer Pain With BEMA™ Fentanyl

Read the detailed description

This was an open label, long-term, extension study designed to provide continued access to EMA Fentanyl to those patients with breakthrough cancer pain who were treated for at least 2 weeks in FEN-202, the long term safety study used for worldwide registration. Patients were followed in an outpatient setting. Use of BEMA Fentanyl and occurrence of serious adverse events (SAEs) were monitored. Throughout the study, all patients continued their background opioid regimen and were permitted to use their rescue medication if adequate pain relief was not realized within 30 minutes following application of BEMA Fentanyl.

Conditions: Respiratory Depression
Being tested: BEMA Fentanyl
Keywords: Chronic Pain, Ventilatory Response to Hypercapnia (VRH)
Medical subject headings: Respiratory Insufficiency, Chronic Pain

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, fentanyl buccal soluble film, ONSOLIS
buccal soluble film; 200, 400, 600, 800, and 1200 mcg fentanyl; up to 4 times daily

Study groups in NCT00696137
Study group	Role	What they receive
BEMA Fentanyl	Experimental	BEMA Fentanyl Receives: Drug: BEMA Fentanyl

What is being measured

The primary outcome is the main question the study is designed to answer.

Efficacy Was Not Measured in This Study. The Number of Deaths in the Long Term Follow-up Will be Reported.
Efficacy was not measured in this study as the intention was to evaluate long term safety in this population. The number of deaths in the long term follow-up will be reported.
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2008Jul 2009

First posted12 Jun 2008 (estimated)
Study startJun 2008
Primary completionJul 2009
Study completionJul 2009

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 Respiratory DepressionStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00696137
Sponsor's protocol ID: FEN-290
Status last verified: Sep 2019
First submitted: 10 Jun 2008
Last updated: 24 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Respiratory Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-label, Long-term Extension Study for Treatment of Breakthrough Cancer Pain With BEMA™ Fentanyl
ClinicalTrials.gov ID: NCT00696137
Acronym / sponsor ID: FEN-290
Conditions: Respiratory Depression
Keywords: Chronic Pain, Ventilatory Response to Hypercapnia (VRH)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 5 participants (actual)
Lead sponsor: BioDelivery Sciences InternationalIndustry (pharma, biotech, devices)
Study start: Jun 2008
Primary completion: Jul 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 12 Jun 2008 (estimated)
Results: Posted 19 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BEMA Fentanyl	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 (3 listed)

previously qualified for and participated in study FEN-202 for at least 2 weeks,
wish to continue using BEMA Fentanyl for treatment of breakthrough pain episodes, and
provide signed informed consent at screening prior to any study procedures.

Key exclusion criteria (2 listed)

they have developed a new medical condition after initial enrollment in FEN-202 which, in the opinion of the investigator, would preclude safe and appropriate use of BEMA Fentanyl or participation in this study, or
there is evidence of improper use of the study drug.

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, fentanyl buccal soluble film, ONSOLISbuccal soluble film; 200, 400, 600, 800, and 1200 mcg fentanyl; up to 4 times daily	Drug	BEMA Fentanyl

Primary outcome

Efficacy Was Not Measured in This Study. The Number of Deaths in the Long Term Follow-up Will be Reported.
Time frame: 3 years
Efficacy was not measured in this study as the intention was to evaluate long term safety in this population. The number of deaths in the long term follow-up will be reported.

Results and safety

Results posted to the registry on 19 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BEMA Fentanyl	5	3

Primary outcome: Efficacy Was Not Measured in This Study. The Number of Deaths in the Long Term Follow-up Will be Reported.

Time frame: 3 years. Count of participants. Unit: Participants

Measure	BEMA Fentanyl n = 5
Value	0

Adverse events

Time frame: 3 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BEMA Fentanyl	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Respiratory Depression

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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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BEMA Fentanyl in people with Respiratory Depression, run by BioDelivery Sciences International.

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 3 inclusion and 2 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 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

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 19 Dec 2018). 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?

Efficacy Was Not Measured in This Study. The Number of Deaths in the Long Term Follow-up Will be Reported. (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00696137.

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 24 Sep 2019.