A Double-Blind, Placebo Controlled Evaluation of the Efficacy, Safety and Tolerability of BEMA™ Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects
- 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
- 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 experiences 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
- Signed consent must be obtained at screening prior to any procedures being performed.
- 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
- 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
- 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