Skip to main content
OpenTrials
Completed

NCT Number: NCT01400854

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer Neoplasms Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cephalon GmbH

Munich, Bavaria, 80339, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Effentora®

Drug

prescribed as per local Summary of Product Characteristics (SmPC) for 4 weeks duration

Primary outcomes

  1. pain relief

    Time frame: 4 weeks

    to show adequate pain relief within 10 minutes

Secondary outcomes

  1. occurrence of adverse events

    Time frame: 4 weeks

    document the tolerability of Effentora®

  2. Change in level of breakthrough pain

    Time frame: 4 weeks

    pursue the possible changes in the history of breakthrough pain during treatment with Effentora

  3. presence of specific triggers for breakthrough pain

    Time frame: 4 weeks

    to investigate the presence of specific triggers (directly or indirectly) with breakthrough pain

  4. quality of life

    Time frame: 4 weeks

    to document the impact of breakthrough pain in different areas of patients' lives and their changes during treatment with Effentora®

Sponsors and collaborators

Lead sponsor

Cephalon

Industry

Registry information

Official study title

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

Acronym: ERKENTNIS

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 22, 2011
Registry last updated
Oct 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.