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Olanzapine 5 MG for Nausea and Vomiting

Phase 3
Waitlist Available
Led By Jonathan Ptachcinski, PharmD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to 5 days after end of the chemotherapy ( days 2-12).
Awards & highlights

Study Summary

Olanzapine for Nausea/Vomiting Prophylaxis in Recipients of Hematopoietic Stem Cell Transplants

Eligible Conditions
  • Nausea and Vomiting

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to 5 days after end of the chemotherapy ( days 2-12).
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to 5 days after end of the chemotherapy ( days 2-12). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Complete Response
Secondary outcome measures
Frequency of Nausea in the Acute Phase
Frequency of Somnolence
Number of Emesis Episodes in Delayed Phase
+7 more

Side effects data

From 2022 Phase 3 trial • 91 Patients • NCT04535141
43%
Constipation
35%
Diarrhea
30%
Activated partial thromboplastin time prolonged
28%
Tachycardia
22%
Headache
20%
hyperglycemia
20%
Hypertension
13%
Insomnia
11%
Pain
7%
Dizziness
7%
Hypotension
4%
Neuropathy
4%
Bradycardia
4%
Creatinine increase
4%
Arrhythmia
4%
Dyspepsia
4%
Fatigue
4%
Infection
2%
aspartate aminotransferase elevated
2%
Confusion
2%
Chest pain
2%
Depression
2%
Hypocalcemia
2%
blood bilirubin increased
2%
Alanine transaminase elevated
2%
hot flashes
2%
Hyponatremia
2%
engraftment syndrome
2%
Abdominal pain
2%
pain in extremity
2%
Dysgeusia
2%
Elevated alkaline phosphatase
2%
Gastroesophageal reflux disease
2%
Hypoxia
2%
Agitation
2%
Non-cardiac chest pain
2%
Renal and urinary disorders - Other, specify
2%
Parkinsonian symptom
2%
Rash maculo-papular
2%
subconjunctival hemorrhage
2%
Edema limbs
2%
Syncope
2%
Tachypnea
2%
Thromboembolic event
100%
80%
60%
40%
20%
0%
Study treatment Arm
Usual Care
Olanzapine

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Olanzapine ArmExperimental Treatment1 Intervention
Olanzapine 5mg tablet with chemotherapy, and 3 days after
Group II: Placebo ArmPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olanzapine 5 MG
2020
Completed Phase 3
~100

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
351 Previous Clinical Trials
88,241 Total Patients Enrolled
1 Trials studying Nausea and Vomiting
19 Patients Enrolled for Nausea and Vomiting
University of North Carolina, Chapel HillOTHER
1,503 Previous Clinical Trials
4,187,581 Total Patients Enrolled
Jonathan Ptachcinski, PharmDPrincipal Investigatorjonathan.Ptachcinski@unchealth.unc.edu

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Olanzapine for Nausea/Vomiting Prophylaxis in Recipients of Hematopoietic Stem Cell Transplants
2020. "Olanzapine for Nausea/Vomiting Prophylaxis in Recipients of Hematopoietic Stem Cell Transplants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04535141.
~19 spots leftby Apr 2025
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