Olanzapine for the Treatment of Refractory Chronic Nausea and Vomiting
Withdrawn before enrolling
Conditions studied: Nausea, Vomiting
In brief
Prospective, observational study evaluating the effect of olanzapine for the treatment of refractory chronic nausea and vomiting.
Key facts
- Study ID
- NCT02977741
- Run by
- Johns Hopkins University
- People needed
- 0
- Starts
- 2016-11-01
- Expected to finish
- 2017-12-01
- Last updated by the study team
- 2018-08-20
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18-65 years of age
- Able to communicate in English without aid of interpreter
- Have chronic refractory nausea, meeting each of the following criteria:
- Baseline nausea and vomiting score on VAS of 25mm or greater
- Duration symptoms of at least 6 months (does not have to be contiguous)
- Intolerance to or inadequate response to prior treatment with both 1) ondansetron or another serotonin (5HT3) antagonist and 2) metoclopramide or domperidone
You may not qualify if…
- History of chemotherapy within the last year
- Current diagnosis of cancer
- Pregnant or breastfeeding
- For females, active efforts to conceive/become pregnant during the time of the study
- Chronic opioid use (3 times a week or greater use)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation of greater than 2x upper limit of normal (within 3 months of enrollment)
- Cirrhosis
- Unable or unwilling to stop using metoclopramide while using olanzapine
- Concomitant use of other antipsychotics (e.g., haloperidol)
- Prolonged corrected QT interval (QTc) (>470ms for men and >480ms for women)
- History of life-threatening arrhythmia
- Hypokalemia (potassium <3.1) or hypomagnesemia (magnesium <1.2)
- Metabolic syndrome, defined as per Adult Treatment Panel III criteria
- Granulocytopenia (absolute neutrophil count <1500)
- History of tardive dyskinesia
- History of acute dystonic reaction to medications
- History of neuroleptic malignant syndrome
Where it is running
- Johns Hopkins University — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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