Clinical trial NCT02977741: Olanzapine for the Treatment of Refractory Chronic Nausea and Vomiting
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Nausea
Vomiting
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Nausea and vomiting severity
timeFrame: 3 months
Secondary outcomes:
measure: Severity of upper gastrointestinal symptoms
timeFrame: 3 months
measure: Quality of life and functional status
timeFrame: 3 months
measure: Symptom-specific anxiety
timeFrame: 3 months
measure: Presence of depression
timeFrame: 3 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
References: