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OpenTrials
Completed

NCT Number: NCT00696137

Long-term Extension Study of BEMA™ Fentanyl

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.

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Key information

Conditions

Respiratory Depression Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BEMA Fentanyl

Drug

buccal soluble film; 200, 400, 600, 800, and 1200 mcg fentanyl; up to 4 times daily

Other names: bioerodible mucoadhesive, fentanyl buccal soluble film, ONSOLIS

Primary outcomes

  1. Efficacy Was Not Measured in This Study. The Number of Deaths in the Long Term Follow-up Will be Reported.

    Time frame: 3 years

    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.

Sponsors and collaborators

Lead sponsor

BioDelivery Sciences International

Industry

Registry information

Official study title

Open-label, Long-term Extension Study for Treatment of Breakthrough Cancer Pain With BEMA™ Fentanyl

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 12, 2008
Registry last updated
Sep 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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