drugset / Trial / NCT04533243

Opioid Titration With 12.5 ug/h Fentanyl Transdermal Patch vs Orally Morphine for Opioid-naïve Patients With Moderate Cancer Pain

NCT04533243

Phase 3 Unknown 209 enrolled Fujian Cancer Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

Opioid is recommended for moderate cancer pain in WHO 3-step analgesic ladder. Transdermal administration of the strong opioid fentanyl was originally developed for patients unable to swallow analgesics because of malignancies in the head and neck region or the gastrointestinal tract, painful lesions in the mouth, or periods of nausea, vomiting, or bowel obstruction. The EMA recognizes that in exceptional clinical circumstances, the 12 μg/h fentanyl patch could be considered. To our knowledge, there is not a phase III trial to explore the efficacy and safety of 12 μg/h fentanyl patch in opioid-naive patients with moderate cancer pain.

Timeline

Start
2020-09-01
Primary completion
2022-08-31
Completion
2022-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Fentanyl Other / unclassified 2.5 ug Other
Comparator Morphine Other / unclassified 5 mg Oral

Indications

No indication recorded.