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Comparison of Olanzapine and Metoclopramide For Treatment Of bReakThrough Emesis

Information source: Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Emesis

Intervention: olanzapine (Drug); metoclopramide (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Martin-Luther-Universität Halle-Wittenberg

Official(s) and/or principal investigator(s):
Karin Jordan, MD, Principal Investigator, Affiliation: Martin-Luther-University Halle-Wittenberg

Summary

This trial is designed to evaluate olanzapine compared to the metoclopramide in the treatment of break through emesis after prophylaxis with dexamethasone, 5-HT 3 receptor antagonists and aprepitant in patients receiving chemotherapy. Efficacy will be assessed using a modified MASCC questionaire with a visual analog scale.

Clinical Details

Official title: Efficacy of Olanzapine in Break-through Emesis After Prophylaxis With Dexamethasone, 5-HT3 Receptor Antagonists and Aprepitant Compared to Metoclopramide

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Primary outcome: Clinical benefit rate

Secondary outcome:

safety

Quality of life

change in urinary excretion of 5 hydroxy indole acetic acid

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- break through emesis after prophylaxis with dexamethasone, 5-HT 3 receptor

antagonists and aprepitant in patients receiving chemotherapy defined as vomitus or nausea>25mm on VAS

- signed IC

Exclusion Criteria:

- psychiatric disorders

- drug abuse

- pregnancy

- high dose chemotherapy

- treatment with other antiemetic drugs

Locations and Contacts

Martin-Luther-University Halle-Wittenberg, Department for Oncology and Hematology, Ernst-Grube-Strasse 40, Halle (Saale), Sachsen-Anhalt 06097, Germany; Recruiting
Karin Jordan, MD, Phone: +49-3455572047, Email: karin.jordan@medizin.uni-halle.de
Karin Jordan, MD, Principal Investigator
Additional Information

Starting date: July 2010
Last updated: September 6, 2011

Page last updated: August 23, 2015

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