Respiratory Depression
Conditions
Keywords
Chronic Pain, Ventilatory Response to Hypercapnia (VRH)
Brief 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.
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.
Interventions
DRUGBEMA Fentanyl
buccal soluble film; 200, 400, 600, 800, and 1200 mcg fentanyl; up to 4 times daily
Sponsors
BioDelivery Sciences International
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. previously qualified for and participated in study FEN-202 for at least 2 weeks, 2. wish to continue using BEMA Fentanyl for treatment of breakthrough pain episodes, and 3. provide signed informed consent at screening prior to any study procedures.
Exclusion criteria
1. 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 2. there is evidence of improper use of the study drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Was Not Measured in This Study. The Number of Deaths in the Long Term Follow-up Will be Reported. | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BEMA Fentanyl BEMA Fentanyl
BEMA Fentanyl: buccal soluble film; 200, 400, 600, 800, and 1200 mcg fentanyl; up to 4 times daily | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | BEMA Fentanyl |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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.
Time frame: 3 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BEMA Fentanyl | Efficacy Was Not Measured in This Study. The Number of Deaths in the Long Term Follow-up Will be Reported. | 0 Participants |