Olanzapine for the Treatment of Refractory Chronic Nausea and Vomiting

NCT ID: NCT02977741

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-12-31

Brief Summary

Prospective, observational study evaluating the effect of olanzapine for the treatment of refractory chronic nausea and vomiting.

Detailed Description

Patients will be identified who are seen in the Johns Hopkins Gastroenterology Clinic, suffer from chronic nausea and vomiting that is refractory to both prokinetic and antiemetic medications, and are being prescribed olanzapine for treatment of nausea and vomiting. Patients who meet criteria will be enrolled and their gastrointestinal symptoms, quality of life, and psychological symptoms will be assessed by various questionnaires and followed over the course of 3 months.

Conditions

Nausea; Vomiting

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Olanzapine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 18-65 years of age
• Able to communicate in English without aid of interpreter
• Have chronic refractory nausea, meeting each of the following criteria:

1. Baseline nausea and vomiting score on VAS of 25mm or greater

2. Duration symptoms of at least 6 months (does not have to be contiguous)

3. Intolerance to or inadequate response to prior treatment with both 1) ondansetron or another serotonin (5HT3) antagonist and 2) metoclopramide or domperidone

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00037144

Identifier Type: -

Identifier Source: org_study_id