Status:
UNKNOWN
Effectiveness and Tolerance of Inhaled Fentanyl Aerosol (25µg/Dose) in Chinese Patients With Breakthrough Cancer Pain
Lead Sponsor:
Lee's Pharmaceutical Limited
Conditions:
Breakthrough Cancer Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 p...
Detailed Description
Stage I: dose-response relationship and safety assessment of inhaled fentanyl aerosol in patients with breakthrough cancer pain. placebo-controlled, cross-over, double-blind randomized design is appli...
Eligibility Criteria
Inclusion
- 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.
- Subjects must consent to take adequate contraception within 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
- 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.
- Subjects are not able to slef evaluate pain intensity using NRS
- Receive surgery in past 3 weeks.
- Treatment with any form of radiotherapy winth 1week prior to study entry that could alter pain or response to pain medication.
- Taking monoamine oxidase inhibitors(MAOIs), CYP3A4 inhibitors or inducers within 14 days of the screening
- Participated in other clinical trials in past 1months.
- Pregnancy and breast-feeding women, women of childbearing age ready to conceive, and pregnancy test positive.
- Other conditions that may affect the informed consent, compliance with the protocol, study results and safety of the subject.
Key Trial Info
Start Date :
March 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 21 2021
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04713189
Start Date
March 15 2021
End Date
December 21 2021
Last Update
February 2 2021
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