Status:
COMPLETED
Long-term Extension Study of BEMA™ Fentanyl
Lead Sponsor:
BioDelivery Sciences International
Conditions:
Respiratory Depression
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 br...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00696137
Start Date
June 1 2008
End Date
July 1 2009
Last Update
September 24 2019
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.