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

Breakthrough Cancer Pain Clinical Trial

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

Clinical Trial Summary

Breakthrough cancer pain (BTcP) is a common problem in patients with cancer. This is a phase IIa dose-response and safety study of inhaled fentanyl aerosol (25µg/dose) in Chinese patients with breakthrough cancer pain.

Clinical Trial Description

Consenting patients who met inclusion and exclusion criteria were allowed to enter the study. The medication for background pain during screening were maintained until the end of the study. Each patient would be treated and observed for 6 episodes of targeted BTcP. Patients were randomly assigned to 1 of the 6 prespecified dose sequences which were established by a computer-generated schedule of active drug and placebo in a 4:2 ratio. All patients and personnel involved with the study (including investigators and investigation site personnel) were blinded to the medication codes. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05531422
Study type Interventional
Source Lee's Pharmaceutical Limited
Contact
Status Completed
Phase Phase 2
Start date October 20, 2021
Completion date April 27, 2023
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