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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

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

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 Summary: 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.
Sponsor: International Clinical Research Institute

Current Primary Outcome: Patient Global Impression of Change [ Time Frame: 30, 60, 90 days ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percent of Patients Satisfied with Treatment [ Time Frame: Baseline, 30, 60, 90 days ]
    Patients will rate their treatment satisfaction using a 5-point scale ranging from 1= Very Dissatisfied to 5= Very Satisfied.
  • Study Medication Ease of Use [ Time Frame: Baseline, 30, 60, 90 days ]
  • Quality of Life [ Time Frame: Baseline, 30, 60, 90 days ]
    Short Form 12 Question Health Survey Version 2 (SF-12v2) will be used to assess a subject's general quality of life.
  • Assessment of Sleep [ Time Frame: Baseline, 30, 60, 90 days ]
    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.
  • Medication Dosing [ Time Frame: Baseline ]
    Equianalgesic dosing will be calculated based on subject's prior dose of Actiq® and final effective dose of Subsys™.
  • Weight [ Time Frame: Baseline, 30, 60, 90 days ]
  • Blood Glucose [ Time Frame: Baseline and 90 days ]
    Blood will be drawn to measure HbA1c.


Original Secondary Outcome: Same as current

Information By: International Clinical Research Institute

Dates:
Date Received: April 25, 2013
Date Started: April 2013
Date Completion:
Last Updated: September 2, 2014
Last Verified: September 2014