Study Comparing Olanzapine With Haloperidol for the Relie... | NCT00124930

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

NCT00124930

Sponsor

Alberta Health services

Status

Terminated

Last Update Posted

Jan 19, 2012Estimated

Enrollment

80Estimated

Phase

Phase 3

Conditions

Nausea
Neoplasms

Interventions

Olanzapine
Haldol

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study suspended due to low enrollment

Expanded Access Info

Start Date

May 2005

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Jul 27, 2005

First Submission Date that Met QC Criteria

Jul 28, 2005

First Posted Date

Jul 29, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2012

Last Update Posted Date

Jan 19, 2012Estimated

Name	Class
Canadian Institutes of Health Research (CIHR)	OTHER_GOV

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Measure	Description	Time Frame
Severity of nausea on days 3 and 5

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jose Pereira	Alberta Cancerboard	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tom Baker Cancer Centre		Calgary	Alberta	T2N 4N2	Canada

Condition Browse Module

MeSH Terms

ID	Term
D009325	Nausea
D009369	Neoplasms

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077152	Olanzapine
D006220	Haloperidol

Ancestor Terms

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
MCT 71119
ISRCTN58624349

Name	Type	Description	Arm Group Labels	Other Names
Olanzapine	Drug
Haldol	Drug