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Epidemiological EMESIS-Registry

This study has been completed.
Sponsor:
Collaborators:
Arbeitsgemeinschaft internistische Onkologie
ASORS
Arbeitskreis Klinische Studien
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
iOMEDICO AG
ClinicalTrials.gov Identifier:
NCT00911222
First received: May 28, 2009
Last updated: October 8, 2012
Last verified: October 2012

May 28, 2009
October 8, 2012
October 2008
May 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00911222 on ClinicalTrials.gov Archive Site
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Epidemiological EMESIS-Registry
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Practitioners specialized in oncology, hematology and/or gynaecology

Antiemetic Therapy
Other: non-interventional
non-interventional
antiemetic treatment
epidemiological registry
Intervention: Other: non-interventional

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1035
August 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00911222
IOM-143, IOM-143
Not Provided
iOMEDICO AG
iOMEDICO AG
  • Arbeitsgemeinschaft internistische Onkologie
  • ASORS
  • Arbeitskreis Klinische Studien
  • Merck Sharp & Dohme Corp.
Principal Investigator: Jan Schröder, Dr. med. / MD Praxis für Hämatologie und Onkologie
iOMEDICO AG
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP