Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- The primary outcome will be the adequacy of symptom control during the last week of the study.
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of gabapentin on symptom control in patients with defined functional dyspepsia refractory to conventional proton pump inhibitor therapy and to compare these effects to that of placebo.
详细描述
In this pilot study we hypothesize that the patients on gabapentin will have an increase in the adequacy of dyspepsia symptom control at two months as well as improvement in dyspepsia symptom index scores which are a surrogate of quality of life measures, when compared to placebo.
While functional dyspepsia is divided into four subtypes most studies have grouped all four as 'functional dyspepsia' and treated them as one. Proton pump inhibition may benefit those with epigastric pain or burning but typically not those with post-prandial fullness or early satiety. (Tack et al). Those patients with symptoms refractory to proton pump inhibition might benefit from a medication that modifies visceral hypersensitivity such as gabapentin. It is possible that by modifying their pain syndrome we can decrease the need for follow-up appointments and improve patient quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients to be included in this study are adults (age >18 years) with defined functional dyspepsia per the ROME III criteria with a negative EGD who are on proton pump inhibitor therapy yet still have a sense of inadequate symptom control.
排除标准
- •Patients excluded will be women of childbearing age who refuse to have a baseline pregnancy test and/or who refuse to prevent pregnancy during the trial period. Exclusion criteria will also include anyone with a history of adverse effect or allergy to gabapentin. Finally, any patient undergoing hemodialysis or with a history of creatinine chronically greater than 1.5 will be excluded.
研究组 & 干预措施
Gabapentin
Half of the 100 patients enrolled will be placed on Gabapentin therapy to determine if they have improved dyspepsia symptoms.
干预措施: Gabapentin (Drug)
Placebo
Half of the 100 patients will be placed on placebo look-alike of the gabapentin.
干预措施: Placebo (Drug)
结局指标
主要结局
The primary outcome will be the adequacy of symptom control during the last week of the study.
时间窗: 2 months
次要结局
- Secondary outcomes equate dyspepsia symptoms with quality of life. The Nepean Dyspepsia Index scores patients on five categories while the Global Overall Symptom Scale measures the severity of dyspepsia on a 1-7 scale.(2 months)