NCT00545740已完成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.
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
- Shire
- 入组人数
- 590
- 试验地点
- 121
- 主要终点
- Percent of Subjects Without Recurrence of Diverticulitis
研究概览
简要总结
The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Males and females =>18yrs of age.
- •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.
- •An episode of acute diverticulitis that resolved without colonic resection.
- •Confirmation of diverticulosis via endoscopic evaluation of the sigmoid colon with at least three diverticula noted.
排除标准
- •Previous colorectal surgery, including surgical intervention for diverticular disease (with the exception of haemorrhoidectomy, colonic removal of polyps, and appendectomy)
- •Active peptic ulcer disease
- •History of or current presence of inflammatory bowel disease (IBD)
- •Subjects with active irritable bowel syndrome (IBS) requiring ongoing medication
- •Allergy or hypersensitivity to aspirin or related compounds
- •Allergy to radiologic contrast agents
- •Use of another Investigational product within 30 days of Baseline
- •Use of antibiotic therapy within 4 weeks of Baseline
- •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
- •Use of systemic or rectal steroids within 6 weeks of Baseline. Use of inhaled or nasal steroids is acceptable
- •Use of anti-inflammatory drugs, (NSIADs, COX-2 inhibitors) including aspirin (except for cardiac prophylaxis) and ibuprofen, on a regular and ongoing basis
- •History of alcohol or other substance abuse within the previous year
- •Active or recent history of endometriosis or dysmenorrhoea within 6 months prior to Baseline
- •Females who are lactating
研究组 & 干预措施
SPD476 (2.4 g)
Experimental
干预措施: SPD476 (2.4 g) (Drug)
SPD476 (1.2 g)
Experimental
干预措施: SPD476 (1.2g) (Drug)
SPD476 (4.8 g)
Experimental
干预措施: SPD476 (4.8 g) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percent of Subjects Without Recurrence of Diverticulitis
时间窗: Up to 104 weeks
Recurrence of diverticulitis is defined as the presence of each and all of the following 3 items: 1) abdominal pain, 2) a 15% increase in white blood cell count from baseline, 3) bowel wall thickening (\>5 mm) and/or fat stranding as evidenced by spiral computerized axial tomography (CT) scan; OR surgical intervention for diverticular disease. Withdrawals are considered as recurrences.
次要结局
- Percent of Subjects Requiring Surgery for Diverticulitis(Up to 104 weeks)
- Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative(Up to 104 weeks)
- Percent of Subjects Who Were CT-Recurrence Free of Diverticulitis(Up to 104 weeks)
- Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive(Up to 104 weeks)
- Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative(Up to 104 weeks)
- Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive(Up to 104 weeks)
研究者
研究点 (121)
Loading locations...
相似试验
已完成
3 期
Prevention of Recurrence of DiverticulitisDiverticulitisNCT00545103Shire592
已完成
3 期
Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative ColitisColitis, UlcerativeNCT00503243Shire280
已完成
3 期
Efficacy and Safety of SPD465 in Adults With ADHDAttention Deficit Disorder With HyperactivityNCT00150579Shire240
已完成
3 期
Efficacy and Safety of SPD465 in Adults With Moderately Symptomatic ADHD.Attention Deficit Disorder With HyperactivityNCT00152022Shire412
已完成
3 期
Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis.Colitis, UlcerativeNCT00151944Shire400