An Observational, Non-Interventional Trial to Assess Patient Satisfaction and Safety of Subsys™ Spray.
|ClinicalTrials.gov Identifier: NCT01901718|
Recruitment Status : Terminated (Enrollment was more challenging than anticipated.)
First Posted : July 17, 2013
Last Update Posted : September 4, 2014
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||4 participants|
|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.|
|Study Start Date :||April 2013|
|Primary Completion Date :||December 2013|
|Study Completion Date :||January 2014|
Cancer patients experiencing breakthrough pain.
- 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.
- 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.
- Optimal Dose Calculation [ Time Frame: 14 Days ]Time to "optimal" dose of an open-label study medication in the Titration phase.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01901718
|United States, Kansas|
|International Clinical Research Institute|
|Overland Park, Kansas, United States, 66210|
|Principal Investigator:||Srinivas Nalamachu, MD||International Clinical Research Institute|