UnknownPhase 1/2

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

96 participantsStarted 2021-03-15

Plain-language summary

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

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Age of 18 to 75years, inclusive.
✓. Subjects must be diagnosed with cancer.
✓. Subjects must be opioid-tolerant : taking oral morphine more than 60mg and less than 1000mg,or taking other equivalent potency opioids of analgesic doses in one weeks or longer.
✓. Subjects must experience persistent pain associated with cancer, and the pain score assessed by NRS should be \<4 within 24hour before screening.
✓. The breakthrough cancer pain score should be ≥4 assessed by NRS.
✓. In the past 7 days, the subject must experience an average of 1 to 4 episodes of breakthrough cancer pain per day, and use 5 mg immediate release morphine at least or equivalent short-acting opioids (e.g., oxycodone, hydrocodone ketones or codeine) to control this pain.
✓. ECOG status of 0 to 2.
✓. Life expectancy should be longer than 3 months.

Exclusion criteria

✕. Allergies, or a history of drug allergies to fentanyl.
✕. On intrathecal or epidural opioids.
✕. HGB \< 80 g/L, NEUT ≤1.5 × 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).
✕. Hepatitis B surface antigen and hepatitis C surface antibody positive. Human T Lymphotropic Virus Type I Positive. HIV positive.
✕. Gastrointestinal bleeding or diarrhea presently.
✕. Requirement of continuous paracentesis.
✕. Tumor infiltration to central nervous system.

What they're measuring

SPID30

Timeframe: During the stage I, at each episode of breakthrough pain, 30 minutes after first dose of study drug.

Trial details

NCT IDNCT04713189

SponsorLee's Pharmaceutical Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-12-21

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