Cancer, Pain
Conditions
Keywords
breakthrough cancer pain
Brief summary
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.
Detailed description
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.
Interventions
DRUGEffentora®
prescribed as per local Summary of Product Characteristics (SmPC) for 4 weeks duration
Sponsors
Cephalon
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* decision to start treatment with Effentora * prescription in accordance with Summary of Product Characteristics (SmPC) * personally signed and dated Informed Consent document
Exclusion criteria
* any subject considered unsuitable according to SmPC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain relief | 4 weeks | to show adequate pain relief within 10 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| occurrence of adverse events | 4 weeks | document the tolerability of Effentora® |
| Change in level of breakthrough pain | 4 weeks | pursue the possible changes in the history of breakthrough pain during treatment with Effentora |
| presence of specific triggers for breakthrough pain | 4 weeks | to investigate the presence of specific triggers (directly or indirectly) with breakthrough pain |
| quality of life | 4 weeks | to document the impact of breakthrough pain in different areas of patients' lives and their changes during treatment with Effentora® |
Countries
Germany
Outcome results
None listed