A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of a 12 Week Treatment of Acute Diverticulitis With Asacol® 2.4 g/Day (400 mg Mesalamine Tablet), Followed by a 9 Month Treatment-free Observation Period
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 2
- 主要终点
- Global Symptom Score (GSS) at Week 12, Primary Efficacy Population
研究概览
简要总结
The purpose of this study is to determine whether Asacol® 2.4 g/day (400 mg Mesalamine) is safe and effective in the treatment of diverticulitis.
详细描述
This study is designed to evaluate the safety and efficacy of Asacol® 2.4 g/day in generally healthy, adult patients who have had an attack of acute diverticulitis. The study will evaluate the safety and efficacy of a 12 week treatment with Asacol® followed a 9 month non-treatment observation period in approximately 180 patients with acute diverticulitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of acute diverticulitis
- •Female patients must be postmenopausal (at least 1 year without spontaneous menses) or surgically sterile or have a negative urine pregnancy test and practice acceptable contraception (e.g., abstinence; oral, intramuscular, or implanted hormonal contraception [at least 3 months prior to enrollment]; 2-barrier methods [e.g., condom, diaphragm, or spermicide]; intrauterine device or verbal report of partner with history of non-reversed vasectomy)
- •Willing and able to participate in the study and provide a signed informed consent
排除标准
- •Presence of diverticular complications (e.g., fistula, abscess, obstruction, stenosis);
- •Active or recent history (within 6 months) of a peptic ulcer;
- •Prior history of irritable bowel syndrome (IBS), as determined by the Investigator;
- •History of major abdominal surgery (as determined by the Investigator);
- •History of GI surgery within 3 months of diagnosis of acute diverticulitis;
- •History of immunocompromising disease, human immunodeficiency virus (HIV) infection, or acquired immunodeficiency syndrome (AIDS);
- •If female patient, active or recent history of endometriosis or dysmenorrhea;
- •Received a dose of a product that contains, or is metabolized to, mesalamine by any route within 4 weeks before the screening visit;
研究组 & 干预措施
Placebo
Days 1 thru Days 10 to 14 (Visit 2): daily antibiotic therapy, dietary advice, and 6 placebo tablets (matching mesalamine) once a day. Visit 2 thru Week 12 : 1 placebo capsule (matching probiotic) and 6 placebo tablets (matching mesalamine) daily.
干预措施: Placebo (Drug)
Placebo
Days 1 thru Days 10 to 14 (Visit 2): daily antibiotic therapy, dietary advice, and 6 placebo tablets (matching mesalamine) once a day. Visit 2 thru Week 12 : 1 placebo capsule (matching probiotic) and 6 placebo tablets (matching mesalamine) daily.
干预措施: Dietary Advice (Other)
Placebo
Days 1 thru Days 10 to 14 (Visit 2): daily antibiotic therapy, dietary advice, and 6 placebo tablets (matching mesalamine) once a day. Visit 2 thru Week 12 : 1 placebo capsule (matching probiotic) and 6 placebo tablets (matching mesalamine) daily.
干预措施: Antibiotic for Diverticulitis (Drug)
Mesalamine
Days 1 thru 10-14 (Visit 2): daily antibiotic therapy, dietary advice and 6 - 400 mg mesalamine tablets once a day. Visit 2 thru Week 12: 1 placebo capsule (matching probiotic) and 6 - 400 mg mesalamine tablets daily.
干预措施: Mesalamine (Drug)
Mesalamine
Days 1 thru 10-14 (Visit 2): daily antibiotic therapy, dietary advice and 6 - 400 mg mesalamine tablets once a day. Visit 2 thru Week 12: 1 placebo capsule (matching probiotic) and 6 - 400 mg mesalamine tablets daily.
干预措施: Dietary Advice (Other)
Mesalamine
Days 1 thru 10-14 (Visit 2): daily antibiotic therapy, dietary advice and 6 - 400 mg mesalamine tablets once a day. Visit 2 thru Week 12: 1 placebo capsule (matching probiotic) and 6 - 400 mg mesalamine tablets daily.
干预措施: Antibiotic for Diverticulitis (Drug)
Mesalamine & Probiotic
Days 1 thru 10-14 (Visit 2): daily antibiotic therapy, dietary advice and 6 - 400 mg mesalamine tablets once daily. Visit 2 thru Week 12: 1- Bifidobacterium infantis 35624 capsule and 6 - 400 mg mesalamine tablets daily
干预措施: Probiotic (Drug)
Mesalamine & Probiotic
Days 1 thru 10-14 (Visit 2): daily antibiotic therapy, dietary advice and 6 - 400 mg mesalamine tablets once daily. Visit 2 thru Week 12: 1- Bifidobacterium infantis 35624 capsule and 6 - 400 mg mesalamine tablets daily
干预措施: Dietary Advice (Other)
Mesalamine & Probiotic
Days 1 thru 10-14 (Visit 2): daily antibiotic therapy, dietary advice and 6 - 400 mg mesalamine tablets once daily. Visit 2 thru Week 12: 1- Bifidobacterium infantis 35624 capsule and 6 - 400 mg mesalamine tablets daily
干预措施: Antibiotic for Diverticulitis (Drug)
结局指标
主要结局
Global Symptom Score (GSS) at Week 12, Primary Efficacy Population
时间窗: 12 Weeks
GSS - Abdominal Pain \& Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).
次要结局
- Percentage of Responders at Week 12 - ITT Population(12 Weeks)
- Percentage of Responders at Week 52 - ITT Population(52 Weeks)
- Change in GSS From Baseline to Week 12 - ITT Population(Baseline to Week 12)
- Change in GSS From Baseline to Week 52 - ITT Population(Baseline to Week 52)
- Withdrawal Due to Surgery for Diverticulitis, Percentage, ITT Population, Week 12(12 Weeks)
- Recurrent Diverticulitis, Percentage, ITT Population, Week 12(12 Weeks)
- Recurrent Diverticulitis, Percentage, ITT Population, Week 52(52 Weeks)