drugset / Trial / NCT00842829

Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients

NCT00842829 ↗

Phase 4 Terminated 330 enrolled Cephalon
RandomizedParallel-groupOpen-label

Summary

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.

Timeline

Start
2009-01
Primary completion
2011-05
Completion
2011-05

Outcome

Outcome not reported

Stopped (Enrollment): “Recruitment stopped at the end of the recruitment timeframe”

Drugs

EvaluationDrugModalityDoseRoute
Subject Fentanyl Other / unclassified 100 ug Oral
Subject Fentanyl Other / unclassified 200 ug Oral

Indications

No indication recorded.