An Observational, Non-Interventional Trial to Assess Patient Satisfaction and Safety of Subsys™ Spray.
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|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|
|Actual Primary Completion Date :||December 2013|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|