Breakthrough Pain Clinical Trial
Official title:
Effectiveness and Tolerance of Inhaled Fentanyl Aerosol (25µg/Dose) in Chinese Patients With BTcP
Verified date | September 2022 |
Source | Lee's Pharmaceutical Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | May 20, 2023 |
Est. primary completion date | May 20, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age of 18years or above 2. Subjects must be diagnosed with cancer. 3. Subjects must experience persistent pain associated with cancer, and the pain score assessed by NRS should be <4 within 1week before screening. 4. 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 5. ECOG status of 0 to 2. 6. 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. 7. The subject must be able to understand the requirements of the study and provide a written informed consent. Exclusion Criteria: 1. Allergies, or a history of drug allergies to fentanyl. 2. 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. 3. Any uncontrolled disease (e.g., severe mental, neurological, infectious, cardiovascular, respiratory and other systemic diseases). 4. Tumor infiltration to central nervous system. 5. Subjects are not able to slef evaluate pain intensity using NRS 6. Receive surgery in past 3 weeks 7. Treatment with any form of radiotherapy winth 1week prior to study entry that could alter pain or response to pain medication. 8. Taking monoamine oxidase inhibitors(MAOIs), CYP3A4 inhibitors or inducers within 14 days of the screening 9. Participated in other clinical trials in past 1months. 10. Pregnancy and breast-feeding women, women of childbearing age ready to conceive, and pregnancy test positive. 11. Other conditions that may affect the informed consent, compliance with the protocol, study results and safety of the subject. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Lee's Pharmaceutical Limited |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | at each episode of breakthrough pain, 30 minutes after first dose of study drug. | |
Secondary | 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. | at each episode of breakthrough pain, 60 minutes after first dose of study drug. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00994760 -
Efficacy and Tolerability of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients Older Than 18 Years
|
N/A | |
Completed |
NCT01842893 -
Efficacy and Safety of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer
|
Phase 3 | |
Completed |
NCT02886286 -
Patient Controlled Intrathecal Analgesia With Bupivacaine for Chronic Low Back Pain
|
Phase 4 | |
Completed |
NCT02869321 -
Analgesic Efficacy of Transmucosal Fentanyl for Breakthrough Pain Caused by Interventional Gastrostomy
|
Phase 4 | |
Completed |
NCT02840500 -
Quality of Life Study in Patients With Cancer Breakthrough Pain Treated in Palliative Care Units
|
N/A | |
Completed |
NCT02437929 -
Procedural Pain in Palliative Care: Prevalence, Intensity and Treatment
|
N/A | |
Completed |
NCT00236145 -
Evaluate the Efficacy and Safety of ACTIQ in Patients With Cancer and Breakthrough Pain
|
Phase 3 | |
Completed |
NCT02836379 -
Quality of Life Study Breakthrough Cancer Pain Treated in Radiation Oncology Services With Palliative Intent
|
N/A | |
Active, not recruiting |
NCT02278601 -
Comparison of Regimens MPIB, CIPCEA, PCEA
|
Phase 3 | |
Terminated |
NCT00842829 -
Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients
|
Phase 4 | |
Recruiting |
NCT05200806 -
A Prospective Pilot Study of a Non-Narcotic Post-Operative Course After Colectomy
|
Phase 4 | |
Withdrawn |
NCT03809455 -
Effectiveness and Tolerance of Fentanyl Citrate in Painful Pain Induced During Diagnostic or Therapeutic Examinations in Cancer Patients
|
Phase 2 | |
Completed |
NCT03435120 -
Quality of Life Study Breakthrough Cancer Pain Treated in Medical Oncology Services (CAVIDIOM)
|
||
Completed |
NCT02050503 -
Intranasal Transmucosal Fentanyl Pectin for Breakthrough Cancer Pain in Radiation-induced Oropharyngeal Mucositis
|
N/A | |
Terminated |
NCT00387010 -
Open-Label Study to Evaluate the Effect of Treatment With Fentanyl Buccal Tablets on Pain Anxiety Symptoms When Used for the Management of Breakthrough Pain
|
Phase 3 | |
Withdrawn |
NCT05053308 -
Proportional Dose of Sublingual Fentanyl Tablet Based on Daily Opioid Requirement
|
N/A | |
Recruiting |
NCT04011150 -
Development of Variable Volume Automated Mandatory Boluses for Patient-controlled Epidural Analgesia During Labour
|
Phase 3 | |
Terminated |
NCT01901718 -
An Observational, Non-Interventional Trial to Assess Patient Satisfaction and Safety of Subsys™ Spray.
|
N/A | |
Completed |
NCT00402350 -
Staccato Fentanyl Single and Multidose PK
|
Phase 1 | |
Completed |
NCT00236041 -
Efficacy/Safety Study of ACTIQ® for Opioid-Tolerant Children and Adolescents With Breakthrough Pain (BTP)
|
Phase 2 |