Effentora® in Clinical Practice - a Non-interventional Study to Evaluate Satisfaction and Tolerability

Pain Clinical Trial

— ERKENTNIS  

Official title:

ERKENTNIS: Effentora® in Clinical Practice - a Non-interventional Study to Evaluate Satisfaction and Tolerability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01400854
• Other study ID #: C25608/5008
• Status: Completed
• Phase: N/A
• First received: July 21, 2011
• Last updated: October 23, 2012
• Start date: July 2011
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesAustria: Federal Office for Safety in Health Care
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer
• Pain

Intervention

Drug:
• Effentora®
prescribed as per local Summary of Product Characteristics (SmPC) for 4 weeks duration

Locations

Country	Name	City	State
Germany	Cephalon GmbH	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain relief	to show adequate pain relief within 10 minutes	4 weeks	No
Secondary	occurrence of adverse events	document the tolerability of Effentora®	4 weeks	No
Secondary	Change in level of breakthrough pain	pursue the possible changes in the history of breakthrough pain during treatment with Effentora	4 weeks	No
Secondary	presence of specific triggers for breakthrough pain	to investigate the presence of specific triggers (directly or indirectly) with breakthrough pain	4 weeks	No
Secondary	quality of life	to document the impact of breakthrough pain in different areas of patients' lives and their changes during treatment with Effentora®	4 weeks	No