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Long-term Extension Study of BEMA™ Fentanyl

Primary Purpose

Respiratory Depression

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
BEMA Fentanyl
Sponsored by
BioDelivery Sciences International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Depression focused on measuring Chronic Pain, Ventilatory Response to Hypercapnia (VRH)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    BEMA Fentanyl

    Arm Description

    BEMA Fentanyl

    Outcomes

    Primary Outcome Measures

    Efficacy Was Not Measured in This Study. The Number of Deaths in the Long Term Follow-up Will be Reported.
    Efficacy was not measured in this study as the intention was to evaluate long term safety in this population. The number of deaths in the long term follow-up will be reported.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 10, 2008
    Last Updated
    September 12, 2019
    Sponsor
    BioDelivery Sciences International
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00696137
    Brief Title
    Long-term Extension Study of BEMA™ Fentanyl
    Official Title
    Open-label, Long-term Extension Study for Treatment of Breakthrough Cancer Pain With BEMA™ Fentanyl
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2008 (undefined)
    Primary Completion Date
    July 2009 (Actual)
    Study Completion Date
    July 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    BioDelivery Sciences International

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    Detailed Description
    This was an open label, long-term, extension study designed to provide continued access to EMA Fentanyl to those patients with breakthrough cancer pain who were treated for at least 2 weeks in FEN-202, the long term safety study used for worldwide registration. Patients were followed in an outpatient setting. Use of BEMA Fentanyl and occurrence of serious adverse events (SAEs) were monitored. Throughout the study, all patients continued their background opioid regimen and were permitted to use their rescue medication if adequate pain relief was not realized within 30 minutes following application of BEMA Fentanyl.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Respiratory Depression
    Keywords
    Chronic Pain, Ventilatory Response to Hypercapnia (VRH)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    5 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    BEMA Fentanyl
    Arm Type
    Experimental
    Arm Description
    BEMA Fentanyl
    Intervention Type
    Drug
    Intervention Name(s)
    BEMA Fentanyl
    Other Intervention Name(s)
    bioerodible mucoadhesive, fentanyl buccal soluble film, ONSOLIS
    Intervention Description
    buccal soluble film; 200, 400, 600, 800, and 1200 mcg fentanyl; up to 4 times daily
    Primary Outcome Measure Information:
    Title
    Efficacy Was Not Measured in This Study. The Number of Deaths in the Long Term Follow-up Will be Reported.
    Description
    Efficacy was not measured in this study as the intention was to evaluate long term safety in this population. The number of deaths in the long term follow-up will be reported.
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: previously qualified for and participated in study FEN-202 for at least 2 weeks, wish to continue using BEMA Fentanyl for treatment of breakthrough pain episodes, and provide signed informed consent at screening prior to any study procedures. Exclusion Criteria: 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 there is evidence of improper use of the study drug.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David Blum, MD
    Organizational Affiliation
    BioDelivery Sciences International
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Long-term Extension Study of BEMA™ Fentanyl

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