NCT00976690已完成3 期
A Multicentre Randomized Open Study Comparing Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn Disease
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives14 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2002年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 14
- 主要终点
- Clinically and endoscopically recurrence at 12 and 24 months
研究概览
简要总结
To show the superiority of Azathioprine comparing Mesalazine in the prevention of postoperative recurrence in Crohn's Disease.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •more than 18 years old
- •Clinical remission at inclusion time (CDAI<150)
- •Having ileocolonic or colon resection 21 days before inclusion
- •Resection > 50cm or subtotal colectomy with ileorectal anastomosis
排除标准
- •Intolerance to one of both study treatment
- •Liver failure (TP<60%)
- •Renal Failure (Creatinine < Lab results)
研究组 & 干预措施
1
Active Comparator
Azathioprine : 2mg/kg/day
干预措施: Azathioprine OR Mesalazine (Drug)
2
Active Comparator
Mesalazine : 4g/day
干预措施: Azathioprine OR Mesalazine (Drug)
结局指标
主要结局
Clinically and endoscopically recurrence at 12 and 24 months
时间窗: 12 and 24 months
次要结局
未报告次要终点
研究者
研究点 (14)
Loading locations...
相似试验
已完成
3 期
Preventing Postoperative Relapse in Crohn's Disease Patients at Risk: Azathioprine Versus MesalazineCrohn's DiseaseNCT00946946Dr. Falk Pharma GmbH78
已完成
4 期
Enteric-coated Mycophenolate Sodium Versus Azathioprine for the Extra-renal Lupus ManifestationsSystemic Lupus ErythematosusNCT01112215Hospital Universitari Vall d'Hebron Research Institute240
Unknown
不适用
Efficacy Study of T2 Versus AZA to Maintain Clinical and Endoscopic Remission in Postoperative Crohn's DiseaseCrohn's DiseaseNCT01015391Jinling Hospital, China100
已完成
3 期
Adalimumab on Preventing Post-chirurgic Recurrence on Crohn´s DiseaseCrohn´s DiseaseNCT01564823Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa86
已完成
4 期
A Study to Explore the Effects of Azilsartan Compared to Telmisartan on Insulin Resistance of Patients With Essential Hypertension on Type 2 Diabetes Mellitus by HOMA-REssential Hypertension Complicated by Type 2 Diabetes MellitusNCT02079805Takeda33