Effectiveness and Tolerance of Inhaled Fentanyl Aerosol (25µg/Dose) in Chinese Patients With BTcP (NCT05531422) | Clinical Trial Compass
CompletedPhase 2
Effectiveness and Tolerance of Inhaled Fentanyl Aerosol (25µg/Dose) in Chinese Patients With BTcP
China60 participantsStarted 2021-10-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age of 18 years or above
✓. Subjects must be diagnosed with cancer.
✓. Subjects must experience persistent pain associated with cancer, and the pain score assessed by NRS should be \<4 within 1week before screening.
✓. In the past 7 days, the subject must experience an average of 1 to 4 episodes of breakthrough cancer pain per day,The breakthrough cancer pain score should be ≥4 assessed by NRS
✓. ECOG status of 0 to 2.
✓. Subjects must consent to take adequate contraception during the study and 1 months after the study. Women of childbearing potential must show negative in the pregnancy test before dosing.
✓. The subject must be able to understand the requirements of the study and provide a written informed consent.
Exclusion criteria
✕. History or suspected allergies to fentanyl.
✕. HGB \< 80 g/L, NEUT ≤1.0 × l09/L, PLT ≤50 × l09/L；ALT and AST higher than 3 times of ULN;total bilirubin and Cr higher than 1.5 times of ULN;PaO2 \<95%;FEV1/FVC\<70% and FEV1 accounted for less than 80% of the predicted value.
✕. Any uncontrolled disease (e.g., severe mental, neurological, infectious, cardiovascular, respiratory and other systemic diseases).
✕. Tumor infiltration to central nervous system.
✕
What they're measuring
1
SPID30
Timeframe: at each episode of breakthrough pain, 30 minutes after first dose of study drug.