NCT00638456已完成2 期
Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis, a Randomized Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Ranjan Dohil
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of Participants With Improvement of Espohageal Eosinophilia
研究概览
简要总结
This study is designed to evaluate whether or not oral viscous budesonide is effective in treating children with Eosinophilic Esophagitis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic evidence of EE defined as greater than 20 eosinophils per hpf on esophageal biopsy
- •Ages 1 yrs and older
- •Ability to continue the same diet that the patient was on at the time of EGD with biopsy
排除标准
- •Adverse reaction or allergy to budesonide
- •Pregnancy
- •Chronic diseases requiring immunomodulatory therapy
- •Use of swallowed topical corticosteroids for EE within the past 3 months
- •Use of systemic steroids 2 months prior to study entry
- •Upper gastrointestinal bleed within 4 months of study entry
- •Chronic use of medications that predispose to upper gastrointestinal bleeding including non-steroidal anti-inflammatory medications or anticoagulants
- •Evidence of adrenal suppression prior to study entry
- •Evidence of concurrent eosinophilic gastritis, enteritis, colitis, or proctitis
- •Recent changes in asthma or allergic rhinitis therapy for 3 months
研究组 & 干预措施
1
Active Comparator
oral viscous budesonide plus Prevacid
干预措施: Budesonide plus Prevacid (Drug)
2
Placebo Comparator
placebo plus Prevacid
干预措施: placebo plus Prevacid (Drug)
结局指标
主要结局
Number of Participants With Improvement of Espohageal Eosinophilia
时间窗: 3 Months
Repeat endoscopy was undertaken using the Olympus P160 endoscope (by RD) at 3 months of treatment.
次要结局
- Upper Gastrointestinal Endoscopy Score(Baseline and 3 Months)
- Symptom Score(Baseline and 3 Months)
研究者
Ranjan Dohil
Professor
University of California, San Diego
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE)Eosinophilic EsophagitisNCT00961233University of North Carolina, Chapel Hill25
已完成
3 期
Budesonide Treatment for Lymphocytic ColitisMicroscopic ColitisNCT00180050Technische Universität Dresden40
招募中
1 期
Evaluation of the efficacy of topical budesonide in the treatment of esophagogastroduodenal Crohn's disease in childreMedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersCrohn's diseaseEUCTR2020-004168-24-PLMedical University of Warsaw138
已完成
4 期
Budesonide Versus Fluticasone for Treatment of Eosinophilic EsophagitisEosinophilic EsophagitisNCT02019758University of North Carolina, Chapel Hill129
已完成
3 期
Budesonide for Induction of Remission in Incomplete Microscopic ColitisIncomplete Microscopic ColitisNCT02142634Dr. Falk Pharma GmbH44