Epidemiological EMESIS-Registry (EMESIS)

December 23, 2014 updated by: iOMEDICO AG

Epidemiologic Registry for the Description of Antiemetic Strategies Under Real-life Conditions.

The purpose of this registry is to record information on reality of anti-emetic therapies of cancer-patients in Germany. The outcome of this study is the efficacy of anti-emetic therapies dependent on the rate "complete and major control" of nausea and emesis in moderately and highly emetogenic chemotherapies, consisting of platin-derivates (cisplatin, carboplatin and oxaliplatin), anthracyclines and/or cyclophosphamid.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1035

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Freiburg, Baden-Württemberg, Germany, 79108
        • iOMEDICO AG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Practitioners specialized in oncology, hematology and/or gynaecology

Description

Inclusion Criteria:

  • Moderately or highly emetogenic chemotherapy consisting of platin-derivates (cisplatin, carboplatin and oxaliplatin), anthracyclines and/or cyclophosphamid.
  • start with the 1st cycle of the regimen (chemo naive patients). Inclusion of pretreated patients is also possible, if the last treatment cycle of a previous chemotherapy was given >= 24 months ago.
  • Compliance with registry procedures
  • Age >= 18 years
  • WHO Performance Status of 0 or 1 (Karnofsky-Index >= 70%)
  • Life expectancy of at least 12 weeks
  • Signed and dated informed consent before the start of the registry

Exclusion Criteria:

  • Mentally incapable or incompliant patients
  • Last chemotherapy <= 24 months (if pretreated)
  • Known hypersensitivity to antiemetic medication
  • unability of the patient to be treated with oral medication
  • pregnancy or lactation period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
antiemetic treatment
epidemiological registry
Other: non-interventional
non-interventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of anti-emetic therapies dependent on the rate "complete and major control" of nausea and emesis in moderately and highly emetogenic chemotherapy regimens.
Time Frame: 4 chemotherapy applications per patient
4 chemotherapy applications per patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iOMEDICO AG

Collaborators

Merck Sharp & Dohme LLC
Arbeitsgemeinschaft fur Internistische Onkologie
Arbeitskreis Klinische Studien
ASORS

Investigators

  • Principal Investigator: Jan Schröder, Dr. med. / MD, Praxis fur Hamatologie und Onkologie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

May 28, 2009

First Submitted That Met QC Criteria

May 29, 2009

First Posted (Estimate)

June 1, 2009

Study Record Updates

Last Update Posted (Estimate)

December 24, 2014

Last Update Submitted That Met QC Criteria

December 23, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IOM-143

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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