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Long-term Extension Study of BEMA™ Fentanyl

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00696137
First Posted: June 12, 2008
Last Update Posted: April 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
BioDelivery Sciences International
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00696137


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

Responsible Party: BioDelivery Sciences International
ClinicalTrials.gov Identifier: NCT00696137     History of Changes
Other Study ID Numbers: FEN-290
First Submitted: June 10, 2008
First Posted: June 12, 2008
Last Update Posted: April 17, 2012
Last Verified: April 2012

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