NCT00209287终止4 期
Study of Histological Modifications, of Pro-apoptotic Effects and of Modifications in Apoptosis Regulators Observed After Stopping 5-ASA Treatment in Patients With Inactive Ulcerative Colitis (Clinical and Endoscopic Remission) Taking 5-ASA
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change between rectal biopsies performed at D1 and D28 of proliferative index
研究概览
简要总结
Male or female, 18 years of age or older. Ulcerative Colitis described according usual criteria, diagnosed for at least 1 year. Oral maintenance treatment with 5-aminosalicylic acid (5-ASA) only for at least 3 months with a dosage of 2 to 3 g/day. Clinical remission for at least 3 months (Mayo Clinic score) and endoscopic remission (endoscopic score of Mayo Clinic) at the inclusion. Signed informed consent form.
详细描述
Inclusion Criteria:
- Male or female, 18 years of age or older.
- Ulcerative colitis described according to usual criteria, diagnosed for at least 1 year.
- Oral maintenance treatment with 5-aminosalicylic acid (5-ASA) only for at least 3 months with a dosage of 2 to 3 g/day.
- Clinical remission for at least 3 months (Mayo Clinic score) and endoscopic remission (endoscopic score of Mayo Clinic) at inclusion.
- Signed informed consent form.
Exclusion Criteria:
- Patients allergic to aspirin or salicylates derivatives
- Patients taking the following treatments during the study will be excluded: corticosteroids (oral or rectal route), use of NSAID or Aspirin, any form of sulfasalazine, mesalazine or 4-ASA.
- Patients with known significant hepatic or known function abnormalities and/or creatine clearance ≤ 80 ml/min.
- Patients with history or physical examination findings indicative of active alcohol or drug abuse.
- Women who are pregnant or nursing.
- Patients with a history of disease, including mental/emotional disorder that would interfere with their participation in the study.
- Patients who participated in another clinical study in the last 3 months.
- Patients who are unable to comply with the requirements of the protocol
- Female of childbearing potential without efficacious contraception.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Male or female, 18 years of age or older.
- •Ulcerative colitis described according to usual criteria, diagnosed for at least 1 year.
- •Oral maintenance treatment with 5-ASA only for at least 3 months with a dosage of 2 to 3 g/day.
- •Clinical remission for at least 3 months (Mayo Clinic score) and endoscopic remission (endoscopic score of Mayo Clinic) at inclusion.
- •Signed informed consent form.
排除标准
- •Patients allergic to aspirin or salicylates derivatives
- •Patients taking the following treatments during the study will be excluded: corticosteroids (oral or rectal route), use of NSAID or Aspirin, any form of sulfasalazine, mesalazine or 4-ASA.
- •Patients with known significant hepatic or known function abnormalities and/or creatine clearance ≤ 80 ml/min.
- •Patients with history or physical examination findings indicative of active alcohol or drug abuse.
- •Women who are pregnant or nursing.
- •Patients with a history of disease, including mental/emotional disorder that would interfere with their participation in the study.
- •Patients who participated in another clinical study in the last 3 months.
- •Patients who are unable to comply with the requirements of the protocol
- •Female of childbearing potential without efficacious contraception.
结局指标
主要结局
Change between rectal biopsies performed at D1 and D28 of proliferative index
时间窗: Its aim was to study histological modifications after Pentasa was stopped in non-active ulcerative colitis.
次要结局
未报告次要终点
研究者
研究点 (1)
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