An Observational, Non-Interventional Trial to Assess Patient Satisfaction and Safety of Subsys™ Spray.

Study Overview
=================
Brief Summary
-----------------
Chronic pain patients who experience breakthrough pain in the background of controlled persistent pain with opioids will be followed for 3 months in order to assess the safety and titration trends in the clinical practice setting of a novel fentanyl sublingual spray (Subsys™) for the treatment of breakthrough pain.

Detailed Description
-----------------
Approximately 100 subjects across 10 centers throughout the United States will be enrolled into the study. Subjects who are currently taking Actiq® for their breakthrough pain and will be discontinued due to lack of efficacy, poor tolerability, patient or prescriber dissatisfaction and meet all other study inclusion criteria and none of the exclusion criteria will be candidates to receive a sublingual fentanyl spray (Subsys™). The total duration of the study for each subject will be no more than 4 months.

Official Title
-----------------
An Observational, Non-Interventional Trial to Assess Patient Satisfaction and Safety of Subsys™ Spray Compared to Actiq® for the Management of Breakthrough Pain in Chronic Pain Patients.

Conditions
-----------------
Breakthrough Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥ 18 years of age. Subjects who are experiencing 1-4 episodes of break through pain per day in spite of optimized background analgesia and who have taken at least 60 mg/day of morphine (or equivalent analgesic) for at least 7 days. Who are currently using Actiq® for their breakthrough pain and are being discontinued due to lack of efficacy, side effects, patient dissatisfaction or prescriber dissatisfaction with treatment. Are able to follow and complete all necessary study procedures. Are willing and able to give written informed consent before participating in the study. Enrolled in the class wide REMS as verified by the study personnel. Exclusion Criteria: Subjects who are not opioid tolerant. Using a rapid onset opioid other than Actiq® to manage their breakthrough pain. Have physical abnormalities of the floor of the mouth that could affect absorption as determined by investigator. Are subjects with uncontrolled or rapidly escalating pain. Are subjects with a history of alcohol or substance abuse within the last 3 years. Have a clinically significant medical history (past or present) of any disease that would compromise the study or the well-being of the subject. Are subjects who have participated in another clinical trial with an analgesic within the last month. Are female subjects with a positive pregnancy test or who are currently lactating. Are subjects who are taking medications that are known inhibitors of the CYP3A4 isozyme, such as ketoconazole. Are subjects who have taken a monoamine inhibitor within 14 days before a dose of study medication. Opioid being used for chronic migraine or acute pain. Are subjects who are unsuitable for inclusion for any other reason, in the opinion of the investigator.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subsys<br>Cancer patients experiencing breakthrough pain. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Impression of Change | The overall impression of change based on a patient's response to the Patient Global Impression of Change (PGIC) questionnaire at month 1, 2, and 3 or upon early discontinuation. | 30, 60, 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Patients Satisfied with Treatment | Patients will rate their treatment satisfaction using a 5-point scale ranging from 1= Very Dissatisfied to 5= Very Satisfied. | Baseline, 30, 60, 90 days | 
| Study Medication Ease of Use |  | Baseline, 30, 60, 90 days | 
| Quality of Life | Short Form 12 Question Health Survey Version 2 (SF-12v2) will be used to assess a subject's general quality of life. | Baseline, 30, 60, 90 days | 
| Assessment of Sleep | Medical Outcomes Score (MOS) Sleep Subscale will be used to measures 6 dimensions of sleep and is a useful indicator of the efficacy of analgesic medications. | Baseline, 30, 60, 90 days | 
| Medication Dosing | Equianalgesic dosing will be calculated based on subject's prior dose of Actiq® and final effective dose of Subsys™. | Baseline | 
| Weight |  | Baseline, 30, 60, 90 days | 
| Blood Glucose | Blood will be drawn to measure HbA1c. | Baseline and 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breakthrough Pain, Subsys, Fentanyl, Opioid, Persistent Pain