NCT02550418已完成2 期
Open-label, Multi-centre, Proof of Concept Phase IIa Clinical Trial on the Efficacy and Tolerability of an 8 Week Oral Treatment With Once Daily 9 mg Budesonide in Patients With Active Ulcerative Colitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Rate of clinical remission at final/withdrawal visit
研究概览
简要总结
The purpose of the trial is to evaluate the efficacy of an 8 week treatment with once-daily 9 mg budesonide in patients with active ulcerative colitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent,
- •Men or women aged 18 to 75 years,
- •Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by endoscopy and histology,
- •Established disease,
排除标准
- •Crohn's disease, indeterminate colitis, ischaemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis, incomplete microscopic colitis), diverticular disease associated colitis,
- •Toxic megacolon or fulminant colitis,
- •Colon resection,
- •Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile toxin in stool culture at screening),
- •Malabsorption syndromes,
- •Celiac disease,
- •Bleeding hemorrhoids,
- •Active peptic ulcer disease
- •Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding,
- •Hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, or infection if careful medical monitoring is not ensured,
- •Any severe infectious disease (e.g., tuberculosis, AIDS),
- •Severe co-morbidity substantially reducing life expectancy,
- •History of colorectal cancer,
- •History of cancer (other than colorectal) in the last 5 years, except for basal cell carcinoma
研究组 & 干预措施
Budesonide
Experimental
干预措施: Budesonide (Drug)
结局指标
主要结局
Rate of clinical remission at final/withdrawal visit
时间窗: 8 weeks treatment
Clinical remission includes normalisation of stool frequency and absence of blood in stools
次要结局
- Rate of endoscopic remission/improvement at final/withdrawal visit(8 weeks treatment)
- Number of stools / bloody stools per week(8 weeks treatment)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Pembrolizumab (MK-3475) in Chinese Participants With Non-Small-Cell Lung Cancer (MK-3475-032/KEYNOTE-032)Non-Small-Cell Lung CancerNCT02835690Merck Sharp & Dohme LLC44
招募中
1 期
Study of ART6043 in Advanced/Metastatic Solid Tumors Patients (POLKA)Advanced Solid TumorMetastatic Solid TumorNCT05898399Artios Pharma Ltd181
Unknown
1 期
An Open Label, Multi-center, Phase I Clinical Study to Evaluate the Safety, Effectiveness and Pharmacokinetic Characteristics of SIM1803-1A in Patients With Locally Advanced/Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion Mutations.Advanced or Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene FusionNCT04671849Jiangsu Simcere Pharmaceutical Co., Ltd.243
已完成
1 期
Safety and Pharmacokinetics of Alpha-1 MP (Alpha1-proteinase Inhibitor (Human), Modified Process) in Participants With Alpha1-Antitrypsin DeficiencyAlpha1-Antitrypsin DeficiencyNCT02870309Grifols Therapeutics LLC4
Unknown
1 期
Phase I Clinical Study of HWH340 Tablet in Patients With Advanced Solid TumorsAdvanced Solid TumorsHRDBRCA MutationNCT03415659Hubei Biological Medicine Industrial Technology Institute Co., Ltd.85