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Comparison of Olanzapine and Metoclopramide For Treatment Of bReakThrough Emesis (COMFORT)

This study is currently recruiting participants.
Verified September 2011 by Martin-Luther-Universität Halle-Wittenberg
Sponsor:
Collaborator:
Koordinationszentrum klinische Studien (KKS) Halle
Information provided by:
Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:
NCT01148264
First received: June 21, 2010
Last updated: September 6, 2011
Last verified: September 2011
History of Changes

June 21, 2010
September 6, 2011
July 2010
December 2011   (final data collection date for primary outcome measure)
Clinical benefit rate [ Time Frame: three days ] [ Designated as safety issue: No ]
no vomitus, no further rescue medication, nausea < 25mm on the visual analog scale (VAS) or reduction on the VAS of >50%
Same as current
Complete list of historical versions of study NCT01148264 on ClinicalTrials.gov Archive Site
  • safety [ Time Frame: five days ] [ Designated as safety issue: Yes ]
    according to NCI-CTC-AE version4.0
  • Quality of life [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    using EORTC-QLQ-C30
  • change in urinary excretion of 5 hydroxy indole acetic acid [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    measurement in 24 hours urine samples
Same as current
Not Provided
Not Provided
 
Comparison of Olanzapine and Metoclopramide For Treatment Of bReakThrough Emesis
Efficacy of Olanzapine in Break-through Emesis After Prophylaxis With Dexamethasone, 5-HT3 Receptor Antagonists and Aprepitant Compared to Metoclopramide

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Emesis
  • Drug: olanzapine
    1x10mg per day for three days
    Other Name: Zyprexa
  • Drug: metoclopramide
    3x10mg per day for three days
    Other Name: Paspertin
  • Experimental: olanzapine
    Intervention: Drug: olanzapine
  • Active Comparator: metoclopramide
    Intervention: Drug: metoclopramide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
86
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
Germany
 
NCT01148264
KKSH 079, 2010-018665-30
No
Karin Jordan, MD, University of Halle
Martin-Luther-Universität Halle-Wittenberg
Koordinationszentrum klinische Studien (KKS) Halle
Principal Investigator: Karin Jordan, MD Martin-Luther-University Halle-Wittenberg
Martin-Luther-Universität Halle-Wittenberg
September 2011

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