Effectiveness and Tolerance of Inhaled Fentanyl Aerosol (25µg/Dose) in Chinese Patients With BTcP
Primary Purpose
Breakthrough Pain
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Fentanyl
Sponsored by
About this trial
This is an interventional treatment trial for Breakthrough Pain
Eligibility Criteria
Inclusion Criteria:
- Age of 18years 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 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 Criteria:
- Allergies, or a history of drug 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.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
placebo
Inhaled fentanyl aerosol
Arm Description
Participants 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
Participants 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
Outcomes
Primary Outcome Measures
SPID30
Weighted sum of pain intensity difference at post dose 30 minutes.Pain intensity at each breakthrough pain (BTP) episode at 0 ,4,8,12,16,20 and 30 minutes after first dose using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is "worst possible pain". PID30 is calculated as the difference in pain intensity from time 0 to 30 minutes. A positive value is a decrease (improvement) of the pain.SPID30=PID4*4+PID8*4+PID12*4+PID16*4+PID20*4+PID30*10
Secondary Outcome Measures
Pain intensity at 0, 4,8,12,16,20,30 and 60 minutes post-dose
Pain intensity at each breakthrough pain (BTP) episode at 0 ,4,8,12,16,20, 30 and 60 minutes after first dose using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is "worst possible pain".A positive value is a decrease (improvement) of the pain.
Full Information
NCT ID
NCT05531422
First Posted
September 4, 2022
Last Updated
September 6, 2022
Sponsor
Lee's Pharmaceutical Limited
1. Study Identification
Unique Protocol Identification Number
NCT05531422
Brief Title
Effectiveness and Tolerance of Inhaled Fentanyl Aerosol (25µg/Dose) in Chinese Patients With BTcP
Official Title
Effectiveness and Tolerance of Inhaled Fentanyl Aerosol (25µg/Dose) in Chinese Patients With BTcP
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 20, 2022 (Anticipated)
Primary Completion Date
May 20, 2023 (Anticipated)
Study Completion Date
May 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lee's Pharmaceutical Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breakthrough Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Participants 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
Arm Title
Inhaled fentanyl aerosol
Arm Type
Experimental
Arm Description
Participants 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
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Placebo
Intervention Description
Participants 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.
Primary Outcome Measure Information:
Title
SPID30
Description
Weighted sum of pain intensity difference at post dose 30 minutes.Pain intensity at each breakthrough pain (BTP) episode at 0 ,4,8,12,16,20 and 30 minutes after first dose using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is "worst possible pain". PID30 is calculated as the difference in pain intensity from time 0 to 30 minutes. A positive value is a decrease (improvement) of the pain.SPID30=PID4*4+PID8*4+PID12*4+PID16*4+PID20*4+PID30*10
Time Frame
at each episode of breakthrough pain, 30 minutes after first dose of study drug.
Secondary Outcome Measure Information:
Title
Pain intensity at 0, 4,8,12,16,20,30 and 60 minutes post-dose
Description
Pain intensity at each breakthrough pain (BTP) episode at 0 ,4,8,12,16,20, 30 and 60 minutes after first dose using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is "worst possible pain".A positive value is a decrease (improvement) of the pain.
Time Frame
at each episode of breakthrough pain, 60 minutes after first dose of study drug.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age of 18years 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 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 Criteria:
Allergies, or a history of drug 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.
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.
12. IPD Sharing Statement
Learn more about this trial
Effectiveness and Tolerance of Inhaled Fentanyl Aerosol (25µg/Dose) in Chinese Patients With BTcP
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