NCT04533243

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

Opioid Titration With 12.5 ug/h Fentanyl Transdermal Patch vs Orally Morphine for Opioid-naïve Patients With Moderate Cancer Pain: A Prospective, Randomized, Controlled, Multi-center, Phase III Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 209 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid, Moderate Cancer Pain, Transdermal Fentanyl, 12.5ug/h, Opioid-naive

Interventions

Type	Name	Description
DRUG	2.5ug/h transdermal fentanyl	2.5ug/h transdermal fentanyl administers for opioid-naive patients with moderate cancer pain very 3 days
DRUG	Oral immediate-released morphine	5mg immediate-released morphine every 4 hours, double dose before sleep.

Timeline

• Start date: 2020-09-01
• Primary completion: 2022-08-31
• Completion: 2022-08-31
• First posted: 2020-08-31
• Last updated: 2020-08-31