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

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

March 15, 2021

Primary Completion Date

December 21, 2021

Study Completion Date

December 21, 2021

Conditions
Breakthrough Cancer Pain
Interventions
DRUG

Inhaled fentanyl aerosol

Participants in the stage I were randomized to 6 BTP episodes, in which 4 BTP episodes were treated with inhale 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 in the stage Ⅰ were randomized to 6 BTP episodes, in which 2 BTP episodes were treated with placebo (0 µg every 4 minutes until adequate pain alleviation. The maximum doses are 6×0µg) in a random sequence. I

Sponsors
All Listed Sponsors
lead

Lee's Pharmaceutical Limited

INDUSTRY