Effentora® in Clinical Practice - a Non-interventional Study to Evaluate Satisfaction and Tolerability (ERKENTNIS)
Aim of this non-interventional study is to investigate the tolerability of Effentora® in cancer pain patients with breakthrough pain under real-life conditions in clinical practice.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||ERKENTNIS: Effentora® in Clinical Practice - a Non-interventional Study to Evaluate Satisfaction and Tolerability|
- pain relief [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]to show adequate pain relief within 10 minutes
- occurrence of adverse events [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]document the tolerability of Effentora®
- Change in level of breakthrough pain [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]pursue the possible changes in the history of breakthrough pain during treatment with Effentora
- presence of specific triggers for breakthrough pain [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]to investigate the presence of specific triggers (directly or indirectly) with breakthrough pain
- quality of life [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]to document the impact of breakthrough pain in different areas of patients' lives and their changes during treatment with Effentora®
|Study Start Date:||July 2011|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Single group prospective treatment cohort
prescribed as per local Summary of Product Characteristics (SmPC) for 4 weeks duration
In addition to the effectiveness of Effentora® therapy, safety, general feasibility and the impact of therapy on the patients' quality of life are of interest.