Long-term Extension Study of BEMA™ Fentanyl

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioDelivery Sciences International
ClinicalTrials.gov Identifier:
NCT00696137
First received: June 10, 2008
Last updated: April 16, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Cancer
Pain
Drug: BEMA Fentanyl
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label, Long-term Extension Study for Treatment of Breakthrough Cancer Pain With BEMA™ Fentanyl

Resource links provided by NLM:


Further study details as provided by BioDelivery Sciences International:

Primary Outcome Measures:
  • Safety and tolerability of BEMA Fentanyl (any dose) as demonstrated by the occurrence of drug-related SAEs. [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]

Enrollment: 5
Study Start Date: June 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
BEMA Fentanyl
Drug: BEMA Fentanyl
buccal soluble film; 200, 400, 600, 800, and 1200 mcg fentanyl; up to 4 times daily
Other Names:
  • bioerobible mucoadhesive
  • fentanyl buccal soluble film
  • ONSOLIS

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00696137

Sponsors and Collaborators
BioDelivery Sciences International
Investigators
Study Chair: David Blum, MD BioDelivery Sciences International
  More Information

No publications provided

Responsible Party: BioDelivery Sciences International
ClinicalTrials.gov Identifier: NCT00696137     History of Changes
Other Study ID Numbers: FEN-290
Study First Received: June 10, 2008
Last Updated: April 16, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fentanyl
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on April 17, 2014