Comparison of Olanzapine and Metoclopramide For Treatment Of bReakThrough Emesis

NCT ID: NCT01148264

Last Updated: 2016-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Emesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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olanzapine

Group Type EXPERIMENTAL

olanzapine

Intervention Type DRUG

1x10mg per day for three days

metoclopramide

Group Type ACTIVE_COMPARATOR

metoclopramide

Intervention Type DRUG

3x10mg per day for three days

Interventions

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olanzapine

1x10mg per day for three days

Intervention Type DRUG

metoclopramide

3x10mg per day for three days

Intervention Type DRUG

Other Intervention Names

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Zyprexa Paspertin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karin Jordan

OTHER

Sponsor Role lead

Responsible Party

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Karin Jordan

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Karin Jordan, MD

Role: PRINCIPAL_INVESTIGATOR

Martin-Luther-University Halle-Wittenberg

Locations

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Martin-Luther-University Halle-Wittenberg, Department for Oncology and Hematology, Ernst-Grube-Strasse 40

Halle, Saxony-Anhalt, Germany

Site Status

Countries

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Germany

Other Identifiers

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2010-018665-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

KKSH 079

Identifier Type: -

Identifier Source: org_study_id

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