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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
History of Changes
  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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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
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 May 23, 2013