Trial Outcomes & Findings for Long-term Extension Study of BEMA™ Fentanyl (NCT NCT00696137)

NCT ID: NCT00696137

Last Updated: 2019-09-24

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 5 participants
• Primary outcome timeframe: 3 years
• Results posted on: 2019-09-24

Participant Flow

Participant milestones

Measure	BEMA Fentanyl BEMA Fentanyl BEMA Fentanyl: buccal soluble film; 200, 400, 600, 800, and 1200 mcg fentanyl; up to 4 times daily
Overall Study STARTED	5
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	BEMA Fentanyl BEMA Fentanyl BEMA Fentanyl: buccal soluble film; 200, 400, 600, 800, and 1200 mcg fentanyl; up to 4 times daily
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Long-term Extension Study of BEMA™ Fentanyl

Baseline characteristics by cohort

Measure	BEMA Fentanyl n=3 Participants BEMA Fentanyl BEMA Fentanyl: buccal soluble film; 200, 400, 600, 800, and 1200 mcg fentanyl; up to 4 times daily
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	BEMA Fentanyl n=5 Participants BEMA Fentanyl BEMA Fentanyl: buccal soluble film; 200, 400, 600, 800, and 1200 mcg fentanyl; up to 4 times daily
Efficacy Was Not Measured in This Study. The Number of Deaths in the Long Term Follow-up Will be Reported.	0 Participants

Adverse Events

BEMA Fentanyl

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tim Warneke

BDSI

Phone: 919-582-0294

Email: twarneke@bdsi.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60