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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Nausea, Neoplasms

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Trial Information

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 haloperidol and
olanzapine in the control of chronic nausea with advanced cancer patients who have failed
first line antiemetic therapy.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Severity of nausea on days 3 and 5

Principal Investigator

Jose Pereira

Investigator Role:

Principal Investigator

Investigator Affiliation:

Alberta Cancerboard

Authority:

Canada: Health Canada

Study ID:

18731

NCT ID:

NCT00124930

Start Date:

May 2005

Completion Date:

June 2008

Related Keywords:

  • Nausea
  • Neoplasms
  • olanzapine
  • haldol
  • cancer
  • nausea
  • second line treatment
  • refractory nausea
  • Neoplasms
  • Nausea

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