Physiology of GERD and Treatment Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Change in GERD Symptoms
研究概览
简要总结
This study is designed to assess the physiologic and behavioral mechanisms associated with enhanced medication effects in adult patients with functional GERD-related symptoms.
详细描述
Subjects will complete questionnaires regarding their GERD-related symptoms and have a visit with a study clinician regarding their symptoms. Heart rate variability and galvanic skin response will be measured in the patient-provider dyads and the visits video recorded. Subjects will receive a two-month supply of amitriptyline (10 mg/day), along with instructions for taking it. Subjects will complete a daily GERD symptom diary during the first and eighth weeks of the study. At the end of the 8-week observation period, subjects will complete follow-up measures of GERD symptom severity and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 24 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults ages 24-64 years old
- •Functional heartburn (defined as <4% of time with reflux on 24 hour pH manometry) symptoms 3 or more days per week with an average daily symptom severity of 3 or more on a 7-day baseline symptom diary
- •English language proficiency
- •Willingness to be videotaped and connected to physiologic monitoring devices during the visit
- •Willingness to take amitriptyline daily for 8 weeks following study visit 1
排除标准
- •Diagnosis of Crohn's disease, systemic sclerosis, known active ulcer disease, gastric cancer, or untreated/active Barrett's esophagitis based on subject self-report and/or medical record review
- •Heavy alcohol use (> 6 drinks/week for women and > 13 drinks/week for men) based on subject self-report
- •Pregnant, attempting to become pregnant, or breast-feeding
- •Dementia or significant memory difficulties as determined by the study team and medical record review
- •Severe, unstable psychiatric disease based on subject self-report, study team determination, and/or medical record review
- •Bipolar disorder, concurrent treatment with a SSRI or another antidepressant that interacts with tricyclic antidepressants
- •Prolonged QTc or severe heart disease
- •History of seizure disorder
- •Severe liver impairment - e.g., cirrhosis, hepatocellular carcinoma, hepatitis
- •Currently taking a tricyclic antidepressant, allergy to tricyclic antidepressants, or another medical contraindication to taking amitriptyline or related medications
- •Greater than 15 doses of nonsteroidal anti-inflammatory drugs (NSAIDS) within the prior 30 days (aspirin ≤ 325 mg daily permitted) or ongoing NSAID use at a level deemed likely to interfere with the study
- •Failure to complete the baseline symptom diary for at least 6 of 7 days
- •Change in GERD treatment regimen within the last 2 weeks (subjects may use antacids, H2 receptor blockers, and/or proton pump inhibitors as long as they are symptomatic on a stable regimen)
- •Allergy to adhesives
- •Inability to provide informed consent
- •In the opinion of the investigator, unable to comply with the study protocol or has a condition that would likely interfere with the study
研究组 & 干预措施
Amitriptyline
Amitriptyline 10 mg daily
干预措施: Amitriptyline (Drug)
结局指标
主要结局
Change in GERD Symptoms
时间窗: Time 0 (baseline) to 8 weeks
Change in the average daily GERD symptom severity score over a 7-day period from baseline to the last week of the study in the expanded vs. standard group. GERD symptom severity is based on the sum of scores assessing the severity of daytime heartburn, nighttime heartburn, and acid reflux each on a 0-4 point scale (none, mild, moderate, severe, very severe; higher scores signify worse symptoms). Possible score range = 0 - 12. Change score calculated as average score at 8 weeks minus average score at baseline. For statistical testing, we used a general linear model of post-GERD symptoms adjusted for baseline GERD symptoms and randomization assignment.
次要结局
- Relationship of Physiologic Concordance in Skin Conductance Between Patient and Physician With Patients' GERD Symptom Change(Time 0 (baseline) to 8 weeks.)