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.
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
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
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 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 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.
- 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)
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
- 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