NCT01120340已完成3 期
Evaluation of Efficacy of Mesalamine in the Long-term Prevention of Diverticulitis Flares
SOFAR S.p.A.17 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2005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
- 105
- 试验地点
- 17
- 主要终点
- diverticulitis relapse
研究概览
简要总结
The purpose of this study is to determine whether mesalamine is effective vs. placebo in the prevention of diverticulitis flares in a 24-months follow-up.
The primary end-point of the study is the incidence of diverticulitis flares. Will be made a clinical diagnosis of uncomplicated diverticulitis: fever, leukocytosis, abdominal pain and altered intestinal motility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •age ≥ 18 years
- •both males and females patients
- •positive history of acute diverticulitis flare during the last year. The patients will be recruited only after the complete clinical remission of diverticulitis flare.
- •patients who have given their free and informed consent
排除标准
- •complicated diverticulitis(fistulas, stenosis, abscesses and/or bleeding)
- •ascertained hypersensitivity to the salicylates
- •any severe pathology that can interfere with the treatment or the clinical or instrumental test of the trial
- •clinically significant renal or hepatic impairment
- •esophageal, gastric or duodenal ulcer within 30 days prior to randomisation
- •patients with active malignancy of any type, or history of a malignancy (patients with a history of malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrollment are also acceptable)
- •treatment with any investigational drug within the previous 30 days
- •treatment with lactulose or with any compound that lowering the colonic pH can prevent the release of the active moiety from the tablets
- •recent history or suspicion of alcohol abuse or drug addiction
- •patients who become unable to conform to protocol
- •patients with ascertained pregnancy
- •previous participation in this study
研究组 & 干预措施
mesalamine
Active Comparator
Posology: mesalamine: 1,6 g/die for ten days every month for 24 months
干预措施: mesalamine (Drug)
placebo
Placebo Comparator
干预措施: placebo (Other)
结局指标
主要结局
diverticulitis relapse
时间窗: 24 months
次要结局
未报告次要终点
研究者
研究点 (17)
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