- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00124930
Study Comparing Olanzapine With Haloperidol for the Relief of Nausea and Vomiting in Patients With Advanced Cancer
January 18, 2012 updated by: Alberta Health services
A Randomized Double-blind, Parallel Group Study Comparing Olanzapine (Zyprexa) With Haloperidol (Novo-peridol) for the Relief of Nausea and Vomiting in Patients With Advanced Cancer
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.
Study Overview
Status
Terminated
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Centre
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Severity of nausea on days 3 and 5
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jose Pereira, Alberta Cancerboard
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2005
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
July 27, 2005
First Submitted That Met QC Criteria
July 28, 2005
First Posted (Estimate)
July 29, 2005
Study Record Updates
Last Update Posted (Estimate)
January 19, 2012
Last Update Submitted That Met QC Criteria
January 18, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Olanzapine
Other Study ID Numbers
- 18731
- MCT 71119
- ISRCTN58624349
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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