Cancer Pain
Conditions
Brief summary
An open-label, single arm, observation study, to assess the efficacy and safety of proportional doses of Painkyl® in patients with breakthrough cancer pain.
Interventions
DRUGFentanyl Buccal Soluble Film
Eligible patients will receive Painkyl® for dose of 200, 400, 600, 800, 1000 or 1200 mcg for the treatment of breakthrough pain according to around-the-clock morphine daily dose.
Sponsors
Mackay Memorial Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients requiring dose titration | At study end (at least 30 subjects completed 2 doses of study treatment without dose titration), around 4 years | Percentage of patients requiring dose titration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity changes at 5, 10, 15, 30 minutes after dosing | At study end (at least 30 subjects completed 2 doses of study treatment without dose titration), around 4 years | Pain score at 5, 10, 15, 30 minutes after dosing vs. pain score before dosing. Pain scale (0-10, 0=no pain to 10=worst pain) will be recorded by subject at the time point of before Painkyl dosing, and at 5, 10, 15, 30 minutes after dosing. |
| Subjects' satisfaction | At study end (at least 30 subjects completed 2 doses of study treatment without dose titration), around 4 years | Subjects' satisfaction (poor, fair, good, very good, excellent) will be recorded by subject for at least 2 assessment |
Countries
Taiwan
Outcome results
None listed