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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01942200
Other study ID # ONKOOXA01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2013
Est. completion date July 25, 2018

Study information

Verified date August 2018
Source Onkovis GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The main purpose of this observational study with Oxaliplatin onkovis is to determine the number of treatment cycles and the quantity of Oxaliplatin onkovis needed for this purpose under the special circumstances of ambulant chemotherapy.

Onkovis aims to contribute to an economical utilization of the chemotherapeutics. This includes provision of appropriate packaging sizes to decrease the excess quantity to be discarded, and thus also follows this objective.

Secondary objective is the assessment of the side effects of Oxaliplatin onkovis. To this end, data regarding co-medication and adverse events are also collected.


Recruitment information / eligibility

Status Completed
Enrollment 383
Est. completion date July 25, 2018
Est. primary completion date July 25, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Indication for Oxaliplatin according to the Summary of Product Characteristics (SmPC) and treating physician

Exclusion Criteria:

- According to the Oxaliplatin SmPC

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Practice Elstra
Germany Practice Leipzig
Germany Practice Naunhof

Sponsors (2)

Lead Sponsor Collaborator
Onkovis GmbH AKP Freiburg GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Quantity of Oxaliplatin onkovis needed per treatment cycle Determine the quantity of Oxaliplatin onkovis needed per treatment cycle up to 24 weeks
Secondary Adverse events during and after treatment The number and type of adverse events during and after the intra-venous application of Oxaliplatin will be assessed and documented. up to 24 weeks
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