Breakthrough Cancer PainPhase 2NCT05531422
Effectiveness and Tolerance of Inhaled Fentanyl Aerosol (25µg/Dose) in Chinese Patients With BTcP
A Phase 2 study testing Inhaled fentanyl aerosol in people with Breakthrough Cancer Pain, run by Lee's Pharmaceutical Limited at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breakthrough Cancer Pain
- What is being tested?
- Inhaled fentanyl aerosol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2021to 27 Apr 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Subjects are not able to slef evaluate pain intensity using NRS
- Receive surgery in past 3 weeks
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Breakthrough Cancer Pain
- Being tested
- Inhaled fentanyl aerosol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled fentanyl aerosolDrug
Participants were randomized to 6 BTP episodes, in which 4 BTP episodes were treated with inhaled 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.
PlaceboDrug
Participants were randomized to 6 BTP episodes, in which 4 BTP episodes were treated with inhaled 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.
| Study group | Role | What they receive |
|---|---|---|
| Inhaled fentanyl aerosol | Experimental | Participants were randomized to 6 BTP episodes, in which 4 BTP episodes were treated with Inhaled fentanyl aerosol (25 µg every 4 minutes until adequate pain alleviation. The maximum doses are 6×25µg) in a random sequence Receives: Drug: Inhaled fentanyl aerosol |
| Placebo | Placebo comparator | 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at each episode of breakthrough pain, 30 minutes after first dose of study drug.
Secondary outcomes (1)
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.
Measured: at each episode of breakthrough pain, 60 minutes after first dose of study drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start20 Oct 2021
- Primary completion15 Mar 2023
- Study completion27 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breakthrough Cancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531422
- Sponsor's protocol ID
- ZK06
- Status last verified
- Jun 2024
- First submitted
- 4 Sep 2022
- Last updated
- 12 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin R, Song B, Li N, Rong B, Bai J, Liu Y, Wang W, Liu A, Luo S, Liu B, Cheng P, Wu Y, Li Y, Yu X, Liu X, Dai X, Li X, Liu D, Wang J, Huang Y. Efficacy and safety of fentanyl inhalant for the treatment of breakthrough cancer pain: a multicenter, randomized, double-blind, placebo-controlled trial. BMC Palliat Care. 2024 Sep 7;23(1):222. doi: 10.1186/s12904-024-01554-9.
PubMed 39244530
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Tolerance of Inhaled Fentanyl Aerosol (25µg/Dose) in Chinese Patients With BTcP
- ClinicalTrials.gov ID
- NCT05531422
- Acronym / sponsor ID
- ZK06
- Conditions
- Breakthrough Cancer Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled fentanyl aerosol | Experimental | Drug: Inhaled fentanyl aerosolParticipants were randomized to 6 BTP episodes, in which 4 BTP episodes were treated with Inhaled fentanyl aerosol (25 µg every 4 minutes until adequate pain alleviation. The maximum doses are 6×25µg) in a random sequence |
| Placebo | Placebo comparator | Drug: PlaceboParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
- Subjects are not able to slef evaluate pain intensity using NRS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled fentanyl aerosolParticipants were randomized to 6 BTP episodes, in which 4 BTP episodes were treated with inhaled 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. | Drug | Inhaled fentanyl aerosol |
| PlaceboParticipants were randomized to 6 BTP episodes, in which 4 BTP episodes were treated with inhaled 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. | Drug | Placebo |
Primary outcome
SPID30
Time frame: at each episode of breakthrough pain, 30 minutes after first dose of study drug.
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
1 secondary outcome
Pain intensity at 0, 4,8,12,16,20,30 and 60 minutes post-dose
Time frame: at each episode of breakthrough pain, 60 minutes after first dose of study drug.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Derived from this study: PubMed 39244530Lin R, Song B, Li N, Rong B, Bai J, Liu Y, Wang W, Liu A, Luo S, Liu B, Cheng P, Wu Y, Li Y, Yu X, Liu X, Dai X, Li X, Liu D, Wang J, Huang Y. Efficacy and safety of fentanyl inhalant for the treatment of breakthrough cancer pain: a multicenter, randomized, double-blind, placebo-controlled trial. BMC Palliat Care. 2024 Sep 7;23(1):222. doi: 10.1186/s12904-024-01554-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inhaled fentanyl aerosol in people with Breakthrough Cancer Pain, run by Lee's Pharmaceutical Limited at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SPID30 (time frame: at each episode of breakthrough pain, 30 minutes after first dose of study drug.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05531422, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.