Effectiveness and Tolerance of Inhaled Fentanyl Aerosol (25µg/Dose) in Chinese Patients With BTcP

PHASE2CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

October 20, 2021

Primary Completion Date

March 15, 2023

Study Completion Date

April 27, 2023

Conditions
Breakthrough Cancer Pain
Interventions
DRUG

Inhaled fentanyl aerosol

Participants were randomized to 6 BTP episodes, in which 4 BTP episodes were treated with inhaled fentanyl aerosol (with a starting dose of 25 µg every 4 minutes until adequate pain alleviation. The maximum doses are 6×25 µg) and 2 BTP episodes with placebo(0 µg every 4 minutes until adequate pain alleviation. The maximum doses are 6×0µg) in a random sequence.

DRUG

Placebo

Participants were randomized to 6 BTP episodes, in which 4 BTP episodes were treated with inhaled fentanyl aerosol (with a starting dose of 25 µg every 4 minutes until adequate pain alleviation. The maximum doses are 6×25 µg) and 2 BTP episodes with placebo(0 µg every 4 minutes until adequate pain alleviation. The maximum doses are 6×0µg) in a random sequence.

Trial Locations (1)

510000

Sun Yat-sen University Cancer Center, Guangzhou

Sponsors
All Listed Sponsors
lead

Lee's Pharmaceutical Limited

INDUSTRY