EUCTR2017-003737-29-NL
进行中（未招募）
1 期
Double-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis - Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Dr. Falk Pharma GmbH
- 入组人数
- 75
- 状态
- 进行中（未招募）
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Inclusion criteria for DB\-treatment phase:
- •\- Signed informed consent
- •\- Male or female patients, \=2 to \<18 years of age
- •\- Confirmed clinico\-pathological diagnosis of EoE according to established diagnostic criteria
- •\- Clinically and histologically active EoE
- •\- Indication for treatment with a steroid
- •\- Negative pregnancy test in female patients of childbearing potential
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 75
- •F.1\.2 Adults (18\-64 years) no
排除标准
- •Exclusion criteria for DB treatment phase:
- •\- Erosive gastroesophageal reflux disease (GERD)
- •\- Achalasia, scleroderma esophagus, or systemic sclerosis
- •\- Other clinically evident causes than EoE for esophageal eosinophilia
- •\- Any concomitant esophageal disease and relevant gastro\-intestinal disease (celiac disease, inflammatory bowel disease, symptomatic Helicobacter pylori associated gastritis or any planned Helicobacter eradication, oropharyngeal or esophageal bacterial, viral, or untreated or inadequately treated fungal infection \[candida esophagitis])
- •\- Any known relevant infectious diseases (e.g., AIDS defining disease, active tuberculosis, hepatitis B, or hepatitis C)
- •\- Diabetes mellitus
- •\- If careful medical monitoring is not ensured: cardiovascular disease, hypertension, osteoporosis, active peptic ulcer disease, glaucoma, cataract, or infection
- •\- History of cancer in the last five years
- •\- History of esophageal surgery at any time or of esophageal dilation procedures within the last 12 weeks prior to screening endoscopy, presence of an acute obstruction and/or need for an immediate endoscopic intervention due to a stricture
结局指标
主要结局
未指定
相似试验
已完成
2 期
Double-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitisNL-OMON50028Dr. Falk Pharma GmbH9
进行中（未招募）
1 期
Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitisActive eosinophilic esophagitis and maintenance of remission in eosinophilic esophagitisMedDRA version: 20.1Level: LLTClassification code 10064220Term: Eosinophilic esophagitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]EUCTR2017-003737-29-PTDr. Falk Pharma GmbH75
进行中（未招募）
1 期
Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitisEUCTR2017-003737-29-DEDr. Falk Pharma GmbH75
进行中（未招募）
1 期
Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitisActive eosinophilic esophagitis and maintenance of remission in eosinophilic esophagitisMedDRA version: 20.1Level: LLTClassification code 10064220Term: Eosinophilic esophagitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]EUCTR2017-003737-29-GRDr. Falk Pharma GmbH75
进行中（未招募）
1 期
Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitisActive eosinophilic esophagitis and maintenance of remission in eosinophilic esophagitisMedDRA version: 20.1 Level: LLT Classification code 10064220 Term: Eosinophilic esophagitis System Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]EUCTR2017-003737-29-ESDr. Falk Pharma GmbH75