Olanzapine for the Treatment of Refractory Chronic Nausea and Vomiting
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Nausea and vomiting severity
研究概览
简要总结
Prospective, observational study evaluating the effect of olanzapine for the treatment of refractory chronic nausea and vomiting.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Nausea and vomiting severity
时间窗: 3 months
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.
次要结局
- 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)