Open-Label Study to Evaluate the Effect of Treatment With Fentanyl Buccal Tablets on Pain Anxiety Symptoms When Used for the Management of Breakthrough Pain
Terminated
Cephalon
Phase 3
2006-12-01
The primary purpose of the study is to evaluate the impact of treatment with fentanyl buccal
tablets on the anxiety symptoms commonly associated with chronic pain in patients with
breakthrough pain (BTP). Other purposes are to assess the management of BTP, to evaluate
patient functioning, and to determine any influences on the successful dose achieved.
Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients
Terminated
Cephalon
Phase 4
2009-01-01
Breakthrough cancer pain (BTcP) is a common problem in patients with cancer. Fentanyl Buccal
Tablet (FBT) is used for the treatment of BTP in adults with cancer who are already receiving
maintenance opioid therapy for chronic cancer pain. FBT treatment should be individually
titrated to an effective dose that provides adequate analgesia and minimizes undesirable
effects. To reach the safest effective dose for the individual patient as soon as possible,
the dose titration process is critical. The aim of this study, conducted under pragmatic
conditions in a large-scale population of cancer patients is to compare the proportion of
patients reaching an effective FBT dose after titration starting with either a 100 mcg dose
or a 200 mcg dose.
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