Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of the Safety of BEMA™ Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioDelivery Sciences International
ClinicalTrials.gov Identifier:
NCT00293020
First received: February 15, 2006
Last updated: September 6, 2012
Last verified: September 2012
Results First Received: February 13, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Pain
Cancer
Intervention: Drug: BEMA Fentanyl

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The enrollment period was 3/14/06 - 6/13/08. Subjects were recruited from academic & private clinics in the US. Two groups of subjects were eligible for enrollment in this study. Subjects were eligible to enter this study following completion of the placebo-controlled study, FEN-201 or they were enrolled directly into this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Open Label Fentanyl Treatment BioErodible Muco Adhesive(BEMA) Fentanyl

Participant Flow:   Overall Study
    Open Label Fentanyl Treatment  
STARTED     244  
COMPLETED     82  
NOT COMPLETED     162  
Withdrawal by Subject                 34  
Adverse Event                 30  
Death                 32  
Lack of Efficacy                 12  
Lost to Follow-up                 4  
Protocol Violation                 6  
Physician Decision                 21  
Other Reason                 22  
No dose taken                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Open Label Fentanyl Treatment BioErodible Muco Adhesive(BEMA) Fentanyl

Baseline Measures
    Open Label Fentanyl Treatment  
Number of Participants  
[units: participants]
  243  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     168  
>=65 years     75  
Age  
[units: years]
Mean ± Standard Deviation
  58.0  ± 12.12  
Gender  
[units: participants]
 
Female     128  
Male     115  
Race (NIH/OMB)  
[units: Participants]
 
American Indian or Alaska Native     0  
Asian     2  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     23  
White     209  
More than one race     0  
Unknown or Not Reported     9  
Region of Enrollment  
[units: participants]
 
United States     243  



  Outcome Measures

1.  Primary:   Percentage of Participants With Adverse Events.   [ Time Frame: Participants were followed for the duration of the study, an average of 126 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Andrew Finn, Pharm.D.
Organization: BioDelivery Sciences International
phone: 919-582-9050
e-mail: AFinn@bdsi.com


No publications provided


Responsible Party: BioDelivery Sciences International
ClinicalTrials.gov Identifier: NCT00293020     History of Changes
Other Study ID Numbers: FEN-202
Study First Received: February 15, 2006
Results First Received: February 13, 2012
Last Updated: September 6, 2012
Health Authority: United States: Food and Drug Administration