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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier:
NCT01400854
First received: July 21, 2011
Last updated: October 23, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Cancer
Pain
Drug: Effentora®

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: ERKENTNIS: Effentora® in Clinical Practice - a Non-interventional Study to Evaluate Satisfaction and Tolerability

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • pain relief [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    to show adequate pain relief within 10 minutes


Secondary Outcome Measures:
  • 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®


Enrollment: 600
Study Start Date: July 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Effentora®
Single group prospective treatment cohort
Drug: Effentora®
prescribed as per local Summary of Product Characteristics (SmPC) for 4 weeks duration

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult cancer patients (in- or out-patients) that are suffering from breakthrough pain

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01400854

Locations
Germany
Cephalon GmbH
Munich, Bavaria, Germany, 80339
Sponsors and Collaborators
Cephalon
Investigators
Study Director: Medical Department Cephalon
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT01400854     History of Changes
Other Study ID Numbers: C25608/5008
Study First Received: July 21, 2011
Last Updated: October 23, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Federal Office for Safety in Health Care

Keywords provided by Teva Pharmaceutical Industries:
breakthrough cancer pain

ClinicalTrials.gov processed this record on July 23, 2014