NCT00209300已完成3 期
Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission. A European Multi-centre Investigator Blinded Randomized Controlled Study of Pentasa Sachet Comparing One Gram Twice With Two Grams Once Daily
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 362
- 试验地点
- 130
研究概览
简要总结
This is a multi-centre, randomised, controlled, investigator blinded study. The randomisation will be done centrally. The patients will be treated for 1 year, with clinical and laboratory assessments at 0, 4, 8 and 12 months.
Endoscopic examination is at enrollment and on completion of the study (at relapse or after 12 months).
Number of Subjects (Planned and Analysed):
- 360 patients for demonstration of non-inferiority between once daily and twice daily;
- 326 to be analysed in per-protocol (PP) analyses; and
- 360 in intention-to-treat (ITT) analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •Patients have an established diagnosis of ulcerative colitis and are in clinical remission with an UC-DAI < 2 at enrollment
- •Extension of the disease > 15 cm distance from anal verge
- •Patients who have had a clinical relapse within the past year. Clinical relapse is defined as activity of the disease for which maintenance therapy had to be adjusted.
- •Patients on oral mesalazine maintenance therapy ≤ 2.5 grams per day
- •18 years or older
- •Signed informed consent
排除标准
- •Patients with evidence of other forms of inflammatory bowel disease, idiopathic proctitis or infectious disease
- •Patients allergic to acetylsalicylic acid and other salicylate derivates aspirin or salicylates derivatives
- •Patients who used mesalazine > 2.5 grams orally in the previous month,
- •Patients who used rectal mesalazine > 3 grams per week in the previous month
- •Use of corticosteroids (oral and/or rectal routes) within the last month
- •Intake of immunosuppressants within the last 3 months
- •Patients with (known) significant hepatic (up to 2 x upper limit of normal) or (known) renal function abnormalities, to 1.5 x upper limit of normal values
- •Patients with history or physical examination findings indicative of active alcohol or drug abuse
- •Patients with a history of disease, including mental/emotional disorders, that would interfere with their participation in the study
- •Women who are pregnant or nursing (non-menopausal women who are sexually active and do not use effective contraceptives, as judged by the investigator, must have a negative pregnancy test)
- •Patients who participated in another clinical study in the last 3 months
- •Patients who were previously participating in this study
- •Patients with any other disease that may influence the study assessment, such as malignant disease, etc.
- •Patients who are unable to comply with any requirements of the protocol
- •Patients who are unable to write or read local language.
研究者
研究点 (130)
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