Olanzapine for Nausea

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of California, San Francisco, CANausea+3 MoreOlanzapine - Drug
Eligibility
30 - 18
All Sexes
What conditions do you have?
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Study Summary

This trial is testing whether adding the drug olanzapine to standard antiemetics will improve control of CINV in children receiving chemotherapy for HSCT conditioning.

Eligible Conditions
  • Cancer
  • Nausea
  • Gastroenteritis
  • Blood Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 13 Secondary · Reporting Duration: up to 1 month

Day 100
Impact of olanzapine on HSCT outcomes on incidence of GVHD
Impact of olanzapine on HSCT outcomes on incidence of veno-occlusive disease
Impact of olanzapine on HSCT outcomes on severity of GVHD
up to 1 month
Association between PeNAT and MASCC Antiemesis Tool (MAT) scores
Safety profile of olanzapine based on Pediatric Adverse Event Rating Scale (PAERs)
Safety profile of olanzapine based on amylase
Safety profile of olanzapine based on creatine phophotase
Safety profile of olanzapine based on prolactin
Safety profile of olanzapine based on toxicities
Triglycerides
Safety profile of olanzapine based on weight
complete CINV control
complete and partial CINV control
up to 8 days
Rate of CIV control during the acute phase

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Olanzapine
1 of 2
Placebo Oral Tablet
1 of 2

Active Control

Non-Treatment Group

200 Total Participants · 2 Treatment Groups

Primary Treatment: Olanzapine · Has Placebo Group · Phase 2

Olanzapine
Drug
ActiveComparator Group · 1 Intervention: Olanzapine · Intervention Types: Drug
Placebo Oral Tablet
Drug
PlaceboComparator Group · 1 Intervention: Placebo Oral Tablet · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 month

Who is running the clinical trial?

Children's Mercy Hospital Kansas CityOTHER
226 Previous Clinical Trials
1,269,455 Total Patients Enrolled
Nationwide Children's HospitalOTHER
313 Previous Clinical Trials
5,215,622 Total Patients Enrolled
Columbia UniversityOTHER
1,316 Previous Clinical Trials
1,623,783 Total Patients Enrolled
The Hospital for Sick ChildrenLead Sponsor
644 Previous Clinical Trials
6,815,973 Total Patients Enrolled
4 Trials studying Nausea
1,477 Patients Enrolled for Nausea
Medical University of South CarolinaOTHER
851 Previous Clinical Trials
5,389,776 Total Patients Enrolled
1 Trials studying Nausea
62 Patients Enrolled for Nausea
University of California, San FranciscoOTHER
2,312 Previous Clinical Trials
11,758,138 Total Patients Enrolled
5 Trials studying Nausea
2,400 Patients Enrolled for Nausea
CancerCare ManitobaOTHER
27 Previous Clinical Trials
5,340 Total Patients Enrolled
University of North Carolina, Chapel HillOTHER
1,383 Previous Clinical Trials
3,938,020 Total Patients Enrolled
2 Trials studying Nausea
322 Patients Enrolled for Nausea
St. Justine's HospitalOTHER
179 Previous Clinical Trials
76,885 Total Patients Enrolled
Tal Schechter-Finkelstein, MDPrincipal InvestigatorThe Hospital for Sick Children
1 Previous Clinical Trials
30 Total Patients Enrolled
Muhammad Ali, MDPrincipal InvestigatorThe Hospital for Sick Children
Lee Dupuis, RPh, PhDPrincipal Investigator - The Hospital for Sick Children
The Hospital for Sick Children
1 Previous Clinical Trials
15 Total Patients Enrolled
1 Trials studying Nausea
15 Patients Enrolled for Nausea

Eligibility Criteria

Age 30 - 18 · All Participants · 11 Total Inclusion Criteria

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Frequently Asked Questions

Is the lower age limit for participation in this research open to individuals below the age of 50?

"As outlined in the eligibility requirements, this trial only accepts participants between 30 months and 18 years of age." - Anonymous Online Contributor

Unverified Answer

Are there multiple facilities conducting this investigation in the U.S. and Canada?

"Currently, 9 clinical trial sites are operating this study in New York, Columbus and Winnipeg as well as 6 other cities. It is beneficial to select a nearby clinic so that the burden of travelling is reduced if you decide to become involved." - Anonymous Online Contributor

Unverified Answer

How many participants are partaking in this trial?

"200 qualified patients are necessary for this study to be successful. These participants can join the trial at Columbia University/Morgan Stanley Children's Hospital in New York, NY or Nationwide Children's Hospital in Columbus, Ohio." - Anonymous Online Contributor

Unverified Answer

Is there a body of research that includes Olanzapine in its scope?

"Olanzapine was initially studied in 2007 at VA Puget Sound Health Care System, and now there are 382 completed trials. Currently, 19 clinical studies involving olanzapine are actively recruiting patients, mostly around New York City." - Anonymous Online Contributor

Unverified Answer

What medical symptoms does Olanzapine typically address?

"Olanzapine is widely employed to treat delusional parasitosis and can be used as a part of an integrated treatment plan for acute agitation, delirium, and unipolar depression." - Anonymous Online Contributor

Unverified Answer

Are there still opportunities available for prospective participants of this research project?

"The clinicaltrials.gov website details that this investigation, which was initially published on August 10th 2017, is currently recruiting participants. The trial's information has been refreshed as recently as April 1st 2022." - Anonymous Online Contributor

Unverified Answer

Are there currently any opportunities to engage in this experiment?

"To be eligible for the study, potential volunteers must have nausea and fall between 30 months to 18 years of age. At present, it is expected that 200 participants will take part in this research trial." - Anonymous Online Contributor

Unverified Answer

What makes this research study distinctive compared to others that have been conducted?

"Currently, 19 trials for Olanzapine are being conducted in 401 cities and 7 countries. This drug was first tested by Eli Lilly & Company back in 2007 with a cohort of 20 participants; following that initial trial, 382 studies have already been concluded." - Anonymous Online Contributor

Unverified Answer

What is the regulatory status of Olanzapine?

"Olanzapine has garnered a safety rating of 2 due to the absence of evidence for efficacy within Phase 2 trials, and limited data indicating its safety." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.