NCT02368717已完成3 期
A Randomized, Double-blind, Placebo-controlled, Multi-centre, Superiority Study Investigating the Efficacy and Safety of PENTASA Enema Compared With Placebo Enema for 4-Week Treatment in Chinese Patients With Left-sided Active Ulcerative Colitis (UC) Followed by a Maximal 28-Week Open-Label Extension Phase of PENTASA Enema and/or PENTASA Tablets
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 281
- 试验地点
- 1
- 主要终点
- Clinical remission after 4 weeks treatment
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of 4-week double-blind treatment with PENTASA enema compared with placebo enema in Chinese patients with mild to moderate active left-sided ulcerative colitis, followed by a maximal 28-week open-label extension phase with PENTASA enema and/or PENTASA tablets.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed or recurrent mild to moderate left-sided active ulcerative colitis
- •Mayo score of at least 4 but not greater than 10 points and a score of ≥ 2 for colonoscopy
- •Extent of colonic involvement and endoscopy subscore of Mayo score as confirmed by colonoscopy
- •The patient is compliant with Patient Daily Diary by having adequately responded to the questions on ≥5 of the most recent full 7 days before the Randomization Visit
- •Negative stool test at screening to rule out parasites and bacterial pathogens
排除标准
- •Patients receiving > 2g/day of oral 5-aminosalicylic acid (5-ASA) products, or receiving topical rectal 5-ASA > 3g/week, within 7 days prior to screening
- •Severe/fulminant ulcerative colitis or toxic dilatation of the colon
- •Prior bowel resection surgery
- •Patients allergic to 5-ASA and derivative, any of the excipients, aspirin, or salicylates
- •Patients with one or more of the diseases: bacillary dysentery, amebic dysentery, chronic schistosomiasis, intestinal tuberculosis and Crohn's disease
- •Patients who are unable to fill in the Patient Daily Diary or follow data-capturing procedures
研究组 & 干预措施
Mesalazine
Experimental
Mesalazine Enema
干预措施: Mesalazine Enema (Drug)
Placebo
Placebo Comparator
Placebo Enema
干预措施: Placebo Enema (Drug)
结局指标
主要结局
Clinical remission after 4 weeks treatment
时间窗: At week 4
Defined as a total Mayo score ≤2 points, with no subscore \>1 point
次要结局
- Change in Quality of Life(From baseline to week 4)
- Clinical response after 4 weeks treatment(At week 4)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
A Clinical Trial to Evaluate the Safety and Efficacy of 20 ml Cerebrolysin in Patients With Vascular DementiaVascular DementiaNCT00947531Ever Neuro Pharma GmbH242
已完成
1 期
Double-Blinded, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Biochemical Activity of Intravenous Cpn10 Administration in Subjects With Mild to Moderate SLE.Lupus Erythematosus, SystemicNCT01838694Invion, Inc.30
已完成
2 期
Multiple Dose Study to Evaluate the Efficacy, Safety and Pharmacodynamics of REMD-477 in Subjects With Type 1 Diabetes MellitusType1 Diabetes MellitusNCT03117998REMD Biotherapeutics, Inc.154
已完成
2 期
Efficacy-safety Study of Sublingual Immunotherapy With Depigmented-polymerized Pollen Extracts to Treat RhinoconjunctivitisAllergic RhinoconjunctivitisNCT00550875Laboratorios Leti, S.L.90
进行中（未招募）
1 期
Safety, Tolerability, and Effectiveness of Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back PainChronic Low-back PainDegenerative Disc DiseaseNCT06053242Creative Medical Technology Holdings Inc45