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

History of Changes

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
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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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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 ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

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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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

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