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: safetyQuality 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
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