An Observation Study to Assess the Efficacy and Safety of Proportional Doses of Painkyl® in Patients With Breakthrough Cancer Pain

Study Overview
=================
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.

Official Title
-----------------
An Observation Study to Assess the Efficacy and Safety of Proportional Doses of Painkyl® in Patients With Breakthrough Cancer Pain

Conditions
-----------------
Cancer Pain

Intervention / Treatment
-----------------
* Drug: Fentanyl Buccal Soluble Film


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cancer patients regularly experienced 1 to 3 breakthrough pain episodes per day that required additional opioids from pain control; 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; at least partial relief of breakthrough pain by use of opioid therapy; able to self-administer the study medication correctly or has an available adult caregiver to administer the study medication correctly; willing and able to complete patient diary with each pain episode. 20 to 80 years of age; Exclusion Criteria: rapidly escalating pain (e.g., regularly more than 3 breakthrough pain episodes per day) that are hard to be controlled by analgesics; history of hypersensitivity or intolerance to fentanyl; cardiopulmonary disease that, in the opinion of the investigator, would significantly increase the risk of respiratory depression; psychiatric/cognitive or neurological impairment that would limit the subject's ability to understand or complete the diary; 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); abnormal oral mucosa which will impede drug absorption; recent history or current evidence of alcohol or other drug substance (licit or illicit) abuse; use of an investigational drug or other rapid-onset opioids drugs within 4 weeks preceding this study; pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fentanyl 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.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients requiring dose titration | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity changes at 5, 10, 15, 30 minutes after dosing | 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. | At study end (at least 30 subjects completed 2 doses of study treatment without dose titration), around 4 years | 
| Subjects' satisfaction | Subjects' satisfaction (poor, fair, good, very good, excellent) will be recorded by subject for at least 2 assessment | At study end (at least 30 subjects completed 2 doses of study treatment without dose titration), around 4 years |