Comparison of Olanzapine and Metoclopramide For Treatment Of bReakThrough Emesis

NCT01148264 | Terminated Phase 2

• 2 other identifiers: KKSH 0792010-018665-30
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Emesis

Keywords

break-through; emesis; break through emesis after prophylaxis with dexamethasone, 5-HT 3RA and aprepitant

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• safety

  five days

• Quality of life

  5 days

• change in urinary excretion of 5 hydroxy indole acetic acid

  5 days

Study Arms (2)

olanzapine

EXPERIMENTAL

Drug: olanzapine

metoclopramide

ACTIVE COMPARATOR

Drug: metoclopramide

Interventions

olanzapine DRUG

1x10mg per day for three days

Also known as: Zyprexa

olanzapine

metoclopramide DRUG

3x10mg per day for three days

Also known as: Paspertin

metoclopramide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• psychiatric disorders
• drug abuse
• pregnancy
• high dose chemotherapy
• treatment with other antiemetic drugs

Sponsors & Collaborators

• Karin Jordan: lead

Study Sites (1)

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

Halle, Saxony-Anhalt, 06097, Germany

Location

MeSH Terms

Conditions

Vomiting

Interventions

Olanzapine; Metoclopramide

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Study Officials

• Karin Jordan, MD

  Martin-Luther-University Halle-Wittenberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: June 22, 2010
• Study Start: July 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2014
• Last Updated: May 11, 2016

Record last verified: 2016-05

Locations

DE (1)