Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 2:39 PM
NCT ID:
NCT05209906
Eligibility Criteria:
Inclusion Criteria:
1. cancer patients regularly experienced 1 to 3 breakthrough pain episodes per day that required additional opioids from pain control;
2. a current regimen of opioids equivalent to 60-360 mg/day of oral morphine or 25-150 mcg/hr of transdermal fentanyl for one week or longer;
3. at least partial relief of breakthrough pain by use of opioid therapy;
4. able to self-administer the study medication correctly or has an available adult caregiver to administer the study medication correctly;
5. willing and able to complete patient diary with each pain episode.
6. 20 to 80 years of age;
Exclusion Criteria:
1. rapidly escalating pain (e.g., regularly more than 3 breakthrough pain episodes per day) that are hard to be controlled by analgesics;
2. history of hypersensitivity or intolerance to fentanyl;
3. cardiopulmonary disease that, in the opinion of the investigator, would significantly increase the risk of respiratory depression;
4. psychiatric/cognitive or neurological impairment that would limit the subject's ability to understand or complete the diary;
5. Severe (Grade 4) mucositis (subjects with less than severe mucositis are permitted and must be instructed to not apply the Painkyl® film at a site of inflammation);
6. abnormal oral mucosa which will impede drug absorption;
7. recent history or current evidence of alcohol or other drug substance (licit or illicit) abuse;
8. use of an investigational drug or other rapid-onset opioids drugs within 4 weeks preceding this study;
9. pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT05209906
Study Brief:
Protocol Section:
NCT05209906