CTRI/2009/091/000450招募中3 期
A Phase III, Randomised, Double-Blind, Dose-Response, Stratified, Placebo-Controlled Study Evaluating the Safety and Efficacy of SPD476 versus Placebo over 104 weeks in the Prevention of Recurrence of Diverticulitis
Shire Pharmaceutical Development Ltd.Hampshire International Business ParkChineham, BasingstokeHampshire, RG24 8EPTelephone: +44 1256 894000 Fax: +44 1256 8947070 个研究点目标入组 584 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 584
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Key Inclusion Criteria:
- •1.Males and females =>18yrs of age.
- •2.If female of childbearing potential (FOCP), has demonstrated a negative beta HCG (human chorionic gonadotropin) serum pregnancy test, and agrees to comply with any applicable contraceptive requirements of the protocol.
- •3.An episode of acute diverticulitis that resolved without colonic resection.
- •4.Confirmation of diverticulosis via endoscopic evaluation of the sigmoid colon with at least three diverticula noted
排除标准
- •Key Exclusion Criteria:
- •1.Previous colorectal surgery, including surgical intervention for diverticular disease (with the exception of haemorrhoidectomy, colonic removal of polyps, and appendectomy)
- •2.Active peptic ulcer disease
- •3.History of or current presence of inflammatory bowel disease (IBD)
- •4.Subjects with active irritable bowel syndrome (IBS) requiring ongoing medication
- •5.Allergy or hypersensitivity to aspirin or related compounds
- •6.Allergy to radiologic contrast agents
- •7.Use of another Investigational product within 30 days of Baseline
- •8.Use of antibiotic therapy within 4 weeks of Baseline
- •9.Within 14 days of Baseline, use of prebiotic, probiotic or 5-ASA medications, as well as drugs active at the 5HT-receptor or anti-spasmodic agents
- •10.Use of systemic or rectal steroids within 6 weeks of Baseline. Use of inhaled or nasal steroids is acceptable
- •11.Use of anti-inflammatory drugs, (NSIADs, COX-2 inhibitors) including aspirin (except for cardiac prophylaxis) and ibuprofen, on a regular and ongoing basis
- •12.History of alcohol or other substance abuse within the previous year
- •13.Active or recent history of endometriosis or dysmenorrhoea within 6 months prior to Baseline
- •14.Females who are lactating
研究者
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