A Randomized, Double-blind, Placebo-controlled Study of the Use of Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Peak Esophageal Eosinophil Count
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled study of oral cromolyn sodium when made into a viscous preparation for the treatment of eosinophilic esophagitis.
详细描述
Eosinophilic esophagitis is an antigen-mediated allergic disease of the esophagus characterized by symptoms of gastrointestinal complaints and eosinophilic inflammation limited to the esophagus. Currently, first line therapeutic recommendations include swallowed, topical steroids or dietary therapy. While both work for the majority of patients, they both have limitations.
The investigators are examining the use of oral cromolyn sodium as a treatment for this condition. This medication is a non-steroid that is already approved for other conditions. When taken orally, it is essentially not absorbed systemically, so side effects are minimal. There is only 1 brief, retrospective report of its use in this condition suggesting it does not work. However, from studying swallowed, topical steroids, it may require formulating the medication into a viscous preparation for it to work.
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
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of eosinophilic esophagitis
排除标准
- •Concomitant treatment with swallowed corticosteroids. Any prior use of swallowed corticosteroids will require a 4 week washout period.
- •Pregnancy (all females of child bearing potential will have urine pregnancy test done at baseline).
- •Evidence of pathologic eosinophilia in other locations in the GI tract.
- •Participation in another research protocol
- •Reduced Renal or Hepatic Function (all subjects will have a baseline creatinine and liver function panel drawn)
研究组 & 干预措施
Oral cromolyn
Subjects randomized to the experimental arm will receive oral cromolyn sodium. The dose will be per current package insert for oral cromolyn:
Subjects 2-12 years of age - 100 mg (1 ampule) 4 times daily Subjects 13-18 years of age - 200 mg (2 ampules) 4 times daily
干预措施: oral cromolyn sodium (Drug)
Placebo
Subjects randomized to placebo will receive normal saline ampules Subjects 2-12 years of age - 1 ampule 4 times daily Subjects 13-18 years of age - 2 ampules 4 times daily
干预措施: Placebo (Drug)
结局指标
主要结局
Peak Esophageal Eosinophil Count
时间窗: 2 months
Measure of the peak esophageal eosinophil count on esophageal biopsy specimens after 2 months of therapy
次要结局
- Symptoms as Measured by Pediatric Eosinophilic Esophagitis Symptom Score(Baseline as compared to 2 months)