NauseaPhase 3NCT00124930
Study Comparing Olanzapine With Haloperidol for the Relief of Nausea and Vomiting in Patients With Advanced Cancer
A Phase 3 study testing Olanzapine and Haldol in people with Nausea and Neoplasms, run by Alberta Health services at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Olanzapine and Haldol
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- May 2005to Jun 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years of age
- Significant nausea/vomiting
- Failed maxeran and domperidone
- Underlying treatment of causes has failed
- Adequate cognitive function
- Communicates well
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Olanzapine, Haldol
- Keywords
- olanzapine, haldol, cancer, nausea, second line treatment, refractory nausea
- Medical subject headings
- Nausea, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
HaldolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of nausea on days 3 and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2005 (estimated)
- Study startMay 2005
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: Study suspended due to low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alberta Health services
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- Jose Pereira, Principal investigator, Alberta Cancerboard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124930
- Sponsor's protocol ID
- 18731
- Other IDs
- MCT 71119, ISRCTN58624349
- Status last verified
- Jan 2012
- First submitted
- 27 Jul 2005
- Last updated
- 19 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00124930
- Acronym / sponsor ID
- 18731
- Keywords
- olanzapine, haldol, cancer, nausea, second line treatment, refractory nausea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study suspended due to low enrollment
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Alberta Health servicesUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- May 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 29 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- >18 years of age
- Significant nausea/vomiting
- Failed maxeran and domperidone
- Underlying treatment of causes has failed
- Adequate cognitive function
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olanzapine | Drug | – |
| Haldol | Drug | – |
Primary outcome
Severity of nausea on days 3 and 5
Results and safety
The study was stopped early (reason given: Study suspended due to low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2012.
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Nausea, Vomiting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Pereira principal investigator
Alberta Cancerboard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olanzapine and Haldol in people with Nausea and Neoplasms, run by Alberta Health services at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study suspended due to low enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of nausea on days 3 and 5. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2012.