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

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ClinicalTrials.gov Identifier: NCT01400854
Recruitment Status : Completed
First Posted : July 22, 2011
Last Update Posted : October 24, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Cancer Pain Drug: Effentora®

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.

Study Design

Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ERKENTNIS: Effentora® in Clinical Practice - a Non-interventional Study to Evaluate Satisfaction and Tolerability
Study Start Date : July 2011
Primary Completion Date : October 2012
Study Completion Date : October 2012
Groups and Cohorts

Group/Cohort Intervention/treatment
Single group prospective treatment cohort
Drug: Effentora®
prescribed as per local Summary of Product Characteristics (SmPC) for 4 weeks duration

Outcome Measures

Primary Outcome Measures :
  1. pain relief [ Time Frame: 4 weeks ]
    to show adequate pain relief within 10 minutes

Secondary Outcome Measures :
  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®

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult cancer patients (in- or out-patients) that are suffering from breakthrough pain

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01400854

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

Responsible Party: Cephalon
ClinicalTrials.gov Identifier: NCT01400854     History of Changes
Other Study ID Numbers: C25608/5008
First Posted: July 22, 2011    Key Record Dates
Last Update Posted: October 24, 2012
Last Verified: October 2012

Keywords provided by Teva Pharmaceutical Industries ( Cephalon ):
breakthrough cancer pain