Long-Term Extension Study of BEMA™ Fentanyl
Information source: BioDelivery Sciences International
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer; Pain
Intervention: BEMA Fentanyl (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: BioDelivery Sciences International Official(s) and/or principal investigator(s):
David Blum, MD, Study Chair, Affiliation: BioDelivery Sciences International
Overall contact:
Iris Breithaupt, BA, Phone: 919-582-9050, Email: ibreithaupt@bsinternational.com
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.
Clinical Details
Official title: Open-Label, Long-Term Extension Study for Treatment of Breakthrough Cancer Pain With BEMA™ Fentanyl
Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary outcome: Safety and tolerability of BEMA Fentanyl (any dose) as
demonstrated by the occurrence of drug-related SAEs.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Iris Breithaupt, BA, Phone: 919-582-9050, Email: ibreithaupt@bsinternational.com Additional Information
Starting date: June 2008
Ending date: December 2008
Last updated: June 10, 2008
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