NCT00124930

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

January 19, 2012

Status Verified

January 1, 2012

Enrollment Period

3.1 years

First QC Date

July 27, 2005

Last Update Submit

January 18, 2012

Conditions

NauseaNeoplasms

Keywords

olanzapinehaldolcancernauseasecond line treatmentrefractory nausea

Outcome Measures

Primary Outcomes (1)

  • Severity of nausea on days 3 and 5

Interventions

OlanzapineDRUG
HaldolDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

MeSH Terms

Conditions

NauseaNeoplasms

Interventions

OlanzapineHaloperidol

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsButyrophenonesKetonesOrganic Chemicals

Study Officials

  • Jose Pereira

    Alberta Cancerboard

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 27, 2005

First Posted

July 29, 2005

Study Start

May 1, 2005

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

January 19, 2012

Record last verified: 2012-01

Locations

CA(1)