Study Comparing Olanzapine With Haloperidol for the Relief of Nausea and Vomiting in Patients With Advanced Cancer

NCT ID: NCT00124930

Last Updated: 2012-01-19

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

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2008-06-30

Brief Summary

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The purpose of this study is to compare the efficacy and safety of Haldol (haloperidol) and olanzapine in the control of chronic nausea with advanced cancer patients who have failed first line antiemetic therapy.

Detailed Description

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The purpose of this study is to compare the efficacy and safety of haloperidol and olanzapine in the control of chronic nausea with advanced cancer patients who have failed first line antiemetic therapy.

Conditions

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Nausea Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Olanzapine

Intervention Type DRUG

Haldol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* \>18 years of age
* Significant nausea/vomiting
* Failed maxeran and domperidone
* Underlying treatment of causes has failed
* Adequate cognitive function
* Communicates well

Exclusion Criteria

* Partial/complete bowel obstruction
* Currently taking Haldol or olanzapine
* Has drug induced extrapyramidal symptoms
* Parkinson's disease
* Undergoing chemotherapy or radiotherapy (RT) to brain, abdomen, stomach or esophagus
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Alberta Health services

OTHER

Sponsor Role lead

Principal Investigators

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Jose Pereira

Role: PRINCIPAL_INVESTIGATOR

Alberta Cancerboard

Locations

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Tom Baker Cancer Centre

Calgary, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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MCT 71119

Identifier Type: -

Identifier Source: secondary_id

ISRCTN58624349

Identifier Type: -

Identifier Source: secondary_id

18731

Identifier Type: -

Identifier Source: org_study_id

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