A Randomized, Double Blind, Crossover Trial Comparing Fexofenadine to Placebo for the Treatment of Proton Pump Inhibitor Refractory Gastroesophageal Reflux Symptoms
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Mean Symptom Severity Score
研究概览
简要总结
The investigators wish to study the effectiveness of Fexofenadine (an over the counter allergy pill) for the treatment of gastroesophageal reflux symptoms in patients who still have symptoms despite being on a proton pump inhibitor. The investigators will do this by giving participants both Fexofenadine (an H1 blocker) for 2 weeks and placebo (sugar pill) for 2 weeks. The participants will not know which drug they are getting at a particular time. This will help the investigators better assess the true effectiveness of Fexofenadine.
详细描述
Around 18-28% of North American adults have gastroesophageal reflux symptoms once per week. Of those patients up to 60% may have an inadequate response to proton pump inhibitors and have persistent symptoms. One possible explanation is that this group of patients has nerve related pain. It is thought that H1 receptor activation may sensitize the gastrointestinal tract and esophagus to pain. H1 blockers such as anti-histamines may play a role in treatment of gastroesophageal reflux symptoms that are refractory to proton pump inhibitors by reducing pain perception. The investigators wish to conduct a randomized control trial to test this hypothesis. The investigators will do this by giving participants both Fexofenadine (an H1 blocker) for 2 weeks and placebo (sugar pill) for 2 weeks. The participants will not know which drug they are getting at a particular time. This will help the investigators better assess the true effectiveness of Fexofenadine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A minimum 6-month history of heartburn and regurgitation, as their main symptom
- •Experience at least 3-4 days with episodes of heartburn or regurgitation per week
- •Female patients who are postmenopausal or using acceptable methods of birth control.
- •Exclusion Criteria (selected)
- •Esophageal stricture
- •Primary esophageal motility disorder
- •Systemic sclerosis
- •Active inflammatory bowel disease
- •Zollinger-Ellison syndrome
- •Active gastric or duodenal ulcer
- •Active infectious or inflammatory conditions of the small or large intestine
- •Malabsorption syndromes of the intestine
- •History of gastrointestinal cancer
- •Current active cancer
- •Prior gastric or intestinal surgery
- •Pregnant or breast feeding
- •Other serious psychiatric or medical disease
排除标准
- 未提供
研究组 & 干预措施
Fexofenadine then Placebo
Patients in this group will get 2 weeks of fexofenadine, then 1 week of nothing, then 2 weeks of placebo.
干预措施: Fexofenadine (Drug)
Fexofenadine then Placebo
Patients in this group will get 2 weeks of fexofenadine, then 1 week of nothing, then 2 weeks of placebo.
干预措施: Placebo - Cap (Drug)
Placebo then Fexofenadine
Patients in this group will get 2 weeks of placebo, then 1 week of nothing, then 2 weeks of fexofenadine.
干预措施: Fexofenadine (Drug)
Placebo then Fexofenadine
Patients in this group will get 2 weeks of placebo, then 1 week of nothing, then 2 weeks of fexofenadine.
干预措施: Placebo - Cap (Drug)
结局指标
主要结局
Mean Symptom Severity Score
时间窗: 2 weeks per treatment
Severity of reflux symptoms on a scale of 0-4 (0=none, 1=mild, 2=moderate, 3=severe, 4=very severe)
Mean Number of Reflux Episodes Per Day
时间窗: 2 weeks per treatment
Mean Rescue Medications Per Day
时间窗: 2 weeks per treatment
Medications such as Tums or Pepcid can be used if reflux symptoms are severe and relief is needed (additional doses of proton pump inhibitors are not allowed beyond the regular dosing)
Mean Percent of Days With Reflux
时间窗: 2 weeks per treatment
Mean GERD-HRQL Questionnaire Score
时间窗: 2 weeks per treatment
The questionnaire consists of 10 questions with responses of 0-5. The responses of the 10 questions are totaled (range of 0-50) where a higher total indicates more severe disease than a lower total.
次要结局
- Patient Medication Preference(Will be assessed at the end of the trial (total trial time is 6 weeks))
- Count of Participants With Side Effects(Will be assessed at the end of the initial treatment period (2 weeks) and at the end of the crossover period (2 weeks))
研究者
Thomas Zikos
Fellow in Gastroenterology
Stanford University