NCT01966783已完成2 期
Randomized, Double-blind, Multicentre Study to Compare the Efficacy and Safety of Budesonide Versus Mesalazine Suppository Versus a Combination Therapy of Budesonide/Mesalazine Suppositories in Patients With Acute Ulcerative Proctitis
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
- 320
- 试验地点
- 2
- 主要终点
- Resolution of clinical symptoms
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of budesonide suppository for the treatment of acute ulcerative proctitis.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active ulcerative proctitis
- •Diagnosis confirmed by endoscopy
- •Established disease or new diagnosis
排除标准
- •Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, diverticular assoc. colitis, microscopic colitis
- •Presence of proctitis of a different origin
- •Prior bowel resection
- •Presence of symptomatic organic disease of the gastrointestinal tract
- •Asthma, tuberculosis, cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, infection if careful medical monitoring is not ensured
- •Local intestinal infection
- •Abnormal hepatic or renal function
- •Oral/rectal/intravenous corticosteroids therapy
- •Existing or intended pregnancy or breast-feeding
- •Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial
研究组 & 干预措施
Budesonide dosage 1
Experimental
Budesonide 2 mg suppository
干预措施: Budesonide 2 mg suppository (Drug)
Budesonide dosage 2
Experimental
Budesonide 4 mg suppository
干预措施: Budesonide 4 mg suppository (Drug)
Mesalazine
Active Comparator
Mesalazine 1g suppository
干预措施: Mesalazine 1 g suppository (Drug)
Combination
Experimental
Budesonide 2 mg suppository/Mesalazine 1 g suppository
干预措施: Budesonide 2 mg suppository/Mesalazine 1 g suppository (Drug)
结局指标
主要结局
Resolution of clinical symptoms
时间窗: 8 weeks
Symptoms as reported in the diary
次要结局
- Rate of patients with clinical remission(8 weeks)
- Rate of clinical and endoscopic remission(8 weeks)
- Rate of improvement(8 weeks)
- Rate of patients with endoscopic remission(8 weeks)
研究者
研究点 (2)
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