Comparison of Olanzapine and Metoclopramide For Treatment Of bReakThrough Emesis

Emesis Clinical Trial

— COMFORT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01148264
• Other study ID #: KKSH 079
• Secondary ID: 2010-018665-30
• Status: Terminated
• Phase: Phase 2
• First received: June 21, 2010
• Last updated: May 10, 2016
• Start date: July 2010
• Est. completion date: October 2014

Study information

• Verified date: May 2016
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: October 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Emesis
• Vomiting

Intervention

Drug:
• olanzapine
1x10mg per day for three days
• metoclopramide
3x10mg per day for three days

Locations

Country	Name	City	State
Germany	Martin-Luther-University Halle-Wittenberg, Department for Oncology and Hematology, Ernst-Grube-Strasse 40	Halle (Saale)	Sachsen-Anhalt

Sponsors (1)

Lead Sponsor	Collaborator
Karin Jordan

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical benefit rate	no vomitus, no further rescue medication, nausea < 25mm on the visual analog scale (VAS) or reduction on the VAS of >50%	three days	No
Secondary	safety	according to NCI-CTC-AE version4.0	five days	Yes
Secondary	Quality of life	using EORTC-QLQ-C30	5 days	No
Secondary	change in urinary excretion of 5 hydroxy indole acetic acid	measurement in 24 hours urine samples	5 days	No