Olanzapine for the Treatment of Refractory Chronic Nausea and Vomiting

NCT02977741 | Withdrawn

• 1 other identifier: IRB00037144
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nausea; Vomiting

Outcome Measures

Primary Outcomes (1)

• Nausea and vomiting severity

  Effect of olanzapine on refractory nausea and vomiting as per changes in patient scoring of the severity of nausea and vomiting on a daily visual analog scale (VAS). Scores range from 0-100, with higher scores indicating more severe symptoms.

  3 months

Secondary Outcomes (4)

• Severity of upper gastrointestinal symptoms

  3 months

• Quality of life and functional status

  3 months

• Symptom-specific anxiety

  3 months

• Presence of depression

  3 months

Interventions

Olanzapine DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients who are seen in the Johns Hopkins Center for Neurogastroenterology, have been identified by the healthcare provider (physician, nurse practitioner, physician assistant) as having refractory chronic nausea and vomiting that has failed a trial of typical treatments (both anti-emetics and pro kinetics), and who will be prescribed olanzapine for the treatment of chronic nausea and vomiting

You may qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: November 30, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 20, 2018

Record last verified: 2018-08

Locations

US (1)