Status:
COMPLETED
Study of the Safety of BEMA™ Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy
Lead Sponsor:
BioDelivery Sciences International
Conditions:
Pain
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety of BEMA fentanyl at any dose in the management of breakthrough pain in cancer subjects on background opioid therapy. The standard of care for these ...
Eligibility Criteria
Inclusion
- Male or non-pregnant and non-lactating female. A female of child-bearing potential is eligible to participate in this study if she is using an acceptable method of birth control.
- 18 years or older
- Patient must have pain associated with cancer or cancer treatment
- Patient must be on a stable current regimen of oral opioids equivalent to 60 - 1000 mg/day of oral morphine or 50 - 300 µg/hr of transdermal fentanyl (e.g. oxycodone 30 mg, methadone 20 mg, and hydromorphone 7.5 mg)
- Regularly experience 1 - 4 breakthrough pain episodes per day that require additional opioids for pain control
- At least partial relief of breakthrough pain by use of opioid therapy
- Subject must be able to self-administer the study medication correctly.
- Subject must be willing and able to complete the electronic diary card with each pain episode.
- Signed consent must be obtained at screening prior to any procedures being performed.
Exclusion
- Psychiatric/cognitive or neurological impairment that would limit the subject's ability to understand or complete the diary
- Cardiopulmonary disease that, in the opinion of the investigator, would significantly increase the risk of respiratory depression
- Recent history or current evidence of alcohol or other drug substance (licit or illicit) abuse
- Rapidly escalating pain that the investigator believes may require an increase in the dosage of background pain medication during the study
- Moderate (Grade 3) to severe (Grade 4) mucositis (subjects with less than moderate mucositis are permitted and must be instructed to not apply the BEMA disc at a site of inflammation)
- Strontium 89 therapy within the previous 6 months
- Any other therapy prior to the study that the investigator considers could alter pain or the response to pain medication.
- Use of an investigational drug within 4 weeks preceding this study • History of hypersensitivity or intolerance to fentanyl
- Regularly more than 4 episodes per day
- ECOG performance status of 4 or 5
- Subject is pregnant, actively trying to become pregnant, breast feeding or not using adequate contraceptive measures
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT00293020
Start Date
February 1 2006
End Date
June 1 2008
Last Update
October 5 2012
Active Locations (1)
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1
ResearchPoint
Austin, Texas, United States, 78746