EUCTR2006-000720-13-DE
进行中（未招募）
不适用
Double-blind, randomised, placebo-controlled, multi-centre phase II study to evaluate the efficacy and safety of three different dosages of oral Trichuris suis ova (TSO) suspension in active Crohn’s disease - TSO vs. placebo in active Crohn’s disease
概览
- 阶段
- 不适用
- 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
- 400
- 状态
- 进行中（未招募）
- 最后更新
- 10年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Signed informed consent,
- •2\. Man or woman between 18 and 75 years of age,
- •3\. Established diagnosis of Crohn’s disease (CD) confirmed by endoscopic and histological, or endoscopic and radiological criteria, all of which since
- •at least 3 months prior to screening,
- •4\. Localisation of CD either in terminal ileum (L1\), in colon (L2\) or
- •ileocolitis (L3\), all without upper gastrointestinal involvement (\- L4\)
- •according to the Montreal classification (2005\),
- •5\. CDAI \=220 and \= 350 at baseline,
- •6\. Serum CRP level \= 2 x upper limit of normal (ULN) or stool calprotectin
- •\> ULN at screening,
排除标准
- •1\. Known Crohn’s lesions in the upper GI\-tract (up to and including the
- •jejunum) with present symptoms,
- •2\. Bowel surgery within the last 3 months prior to baseline,
- •3\. Resection of more than 50 cm of the ileum,
- •4\. Ileostomy or colostomy,
- •5\. Septic complications,
- •6\. Evidence of infectious diarrhoea (i.e., pathogenic bacteria or Clostridium
- •difficile toxin in stool culture),
- •7\. Abscess, perforation, active fistulas, or active perianal lesions,
- •8\. Immediate surgery required (e.g., major stenosis, serious bleeding,
结局指标
主要结局
未指定
相似试验
进行中（未招募）
1 期
Double-blinded, randomised, placebo-controlled, multicentre , Phase IIa study to investigate the effect efficacy, safety and tolerability of phosphorylcholine human monoclonal antibody (PC-mAb) 3G10 on arterial inflammation, together with safety and tolerability, in subjects with elevated lipoprotein a (Lp[a ])Arterial inflammation in subjects with elevated lipoprotein a (Lp[a])MedDRA version: 20.0Level: LLTClassification code 10051615Term: Atherosclerotic cardiovascular diseaseSystem Organ Class: 100000022953Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2017-002106-13-SEAthera Biotechnologies AB40
进行中（未招募）
1 期
Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study on the efficacy and tolerability of budesonide capsules versus placebo for maintenance of remission in patients with collagenous colitis - SOIBD Collagenous Colitis Maintenance Study (SCCMS)Collagenous colitisMedDRA version: 8.1 Level: LLT Classification code 10048928 Term: Colitis collagenousEUCTR2007-001315-31-BEDr. Falk Pharma GmbH92
进行中（未招募）
不适用
Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study on the efficacy and tolerability of budesonide capsules versus placebo for maintenance of remission in patients with collagenous colitis - SOIBD Collagenous Colitis Maintenance Study (SCCMS)Collagenous colitisMedDRA version: 13.1Level: PTClassification code 10048928Term: Colitis collagenousSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2007-001315-31-DKDr. Falk Pharma GmbH110
进行中（未招募）
不适用
Study to evaluate the effectiveness and safety of 3 doses ofembryonated eggs of the porcine whipworm compared to placebo(dummy drug) in the treatment of active Crohn's disease.EUCTR2006-000720-13-CZDr. Falk Pharma GmbH400
进行中（未招募）
不适用
Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study on the efficacy and tolerability of budesonide capsules versus placebo for maintenance of remission in patients with collagenous colitis - SOIBD Collagenous Colitis Maintenance Study (SCCMS)Collagenous colitisMedDRA version: 14.1Level: LLTClassification code 10048928Term: Colitis collagenousSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2007-001315-31-DEDr. Falk Pharma GmbH110