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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00124930
• Other study ID #: 18731
• Secondary ID: MCT 71119ISRCTN5
• Status: Terminated
• Phase: Phase 3
• First received: July 27, 2005
• Last updated: January 18, 2012
• Start date: May 2005
• Est. completion date: June 2008

Study information

• Verified date: January 2012
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nausea
• Neoplasms

Intervention

Drug:
• Olanzapine

• Haldol

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
Alberta Health Services	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of nausea on days 3 and 5