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.
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.
Study Type
OBSERVATIONAL
Enrollment
4
International Clinical Research Institute
Overland Park, Kansas, United States
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.
Time frame: 30, 60, 90 days
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.
Time frame: Baseline, 30, 60, 90 days
Study Medication Ease of Use
Time frame: 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.
Time frame: 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.
Time frame: 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™.
Time frame: Baseline
Weight
Time frame: Baseline, 30, 60, 90 days
Blood Glucose
Blood will be drawn to measure HbA1c.
Time frame: Baseline and 90 days
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