EUCTR2007-003553-82-LT进行中（未招募）不适用
A Randomized, Double-blind, Placebo-controlled Study of AGI-003 (Arverapamil) in the Treatment of Irritable Bowel Syndrome with Diarrhea (IBS-D) - ARDIS-1
AGI Therapeutics Research Ltd0 个研究点目标入组 1,000 人开始时间: 2008年2月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female patients, 18 to 75 years of age inclusive, meeting ROME III criteria for IBS-D, willing to abstain from taking rescue medication in the run in phase, and free of any cardiac contraindication to verapamil and who meet all the of the following inclusion/exclusion criteria.
- •1)Age 18-75 years inclusive
- •2)Fulfil ROME III criteria for IBS-D and at screening report their usual abdominal pain /discomfort score at no greater than 4 on the scale of 1-6.
- •3)Provide signed written informed consent
- •4)Must be able to make entries into a touch tone telephone diary on a daily basis
- •5)Must be willing to abstain from taking rescue medication in the run-in phase
- •6)Must be willing to abstain from eating grapefruit or drinking grapefruit juice for the treatment phase of the study
- •If the patient meets the above criteria, then the criteria for randomization after the run-in period are the following:
- •1)Be compliant in the use of IVRS for at least 11 of the run-in days.
- •2)Has typical bowel movements on a minimum of 7 days and at least 50% of the run-in period days, e.g., 8 of 15 days reported as 5, 6 or 7 on the BSS with the IVRS.
- •3)Has abdominal discomfort or pain on a minimum of 7 days and at least 50% of the run-in period days, which need not be consecutive. For the days when they report on IVRS their average pain score must be 0.5-4.0 on the pain scale.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1)During screening the patient reports their usual abdominal pain/discomfort score is 5 or 6 on a scale of 1-6
- •2)Any evidence of cardiovascular disease or any other disease where treatment with verapamil is contra-indicated such as:
- •Severe left ventricular dysfunction
- •Hypotension (systolic pressure <90 mm Hg) or cardiogenic shock
- •Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker)
- •Second- or third-degree AV block (except in patients with a functioning artificial ventricular pacemaker)
- •Patients with atrial flutter or atrial fibrillation and an accessory bypass tract (e.g. Wolff-Parkinson-White, Lown-Ganong-Levine syndromes)
- •3)Lactose intolerance as reported by the patient and patient is not currently abstaining from milk products or not taking lactase enzyme OTC products and for the duration of the study will not agree to continuing to abstain or will not agree to continue their OTC medication
- •4)Coeliac disease (diagnosed using serology or duodenal biopsy)
- •5)Unexplained fever or weight loss of at least 10 pounds during the last 6 months, or any clinically significant symptoms (e.g. rectal bleeding or a recent change in pattern of bowel habits, unless a pre-screening colonoscopy to eliminate any other diseases of the gastrointestinal tract might explain the symptoms)
- •6)Abnormal screening lab tests assessed by the Investigator as clinically significant or within 3 months of the screening visit have had a positive stool cultures or abnormal proctoscopy/abdominal ultrasound requiring further investigation
- •7)Presence of ongoing organic disease of the gastrointestinal tract, liver, pancreas, biliary tree (e.g. gastritis, symptomatic gallstones, duodenal ulcer, gastroenteritis, diverticulitis, or megacolon) with the exception of haemorrhoids, hiatus hernia and non-symptomatic gallstones
- •8)Prior gastroparesis diagnosis by a physician
- •9)Barrett’s and/or Grade III esophagitis
- •10)> 1 episode of vomiting per week within a month prior to screening
- •11)Acute diverticulitis or a history of greater than 1 episode of diverticulitis
- •12)History of chronic colitis or acute self-limiting colitis of any etiology within 5 years of the screening visit (e.g. ulcerative colitis, Crohn’s disease, collagen vascular disease, ischemic colitis, enteric infection)
- •13)History of intestinal obstruction, stricture, toxic megacolon, gastrointestinal perforation, faecal impaction, gastric banding or bariatric surgery
- •14)History of laxative abuse as determined by the Investigator
- •15)Gastroesophageal reflux disease that is not controlled by the use of stable doses of PPIs for at least 3 months prior to the screening visit
- •16)Radiologic or clinical evidence of primary and metastatic gastrointestinal malignancy, stricture or obstruction of the gastrointestinal tract, paralytic ileus or intestinal atony
- •17)History of gastrointestinal bleeding based on clinical judgement that would interfere with the subject’s safety or with the efficacy assessments of the study, or if the subject has had gastrointestinal bleeding on 2 or more occasions within 6 weeks prior to study enrolment (except blood from haemorrhoids)
- •18)History of major gastric, hepatic, pancreatic or intestinal surgery or perforation (excluding cholecystectomy, appendectomy, haemorrhoidectomy or polypectomy)
- •19)Presence of pathogenic parasites, ova, bacteria or any occult blood in stools which in the opinion of the Investigator may be responsible for G
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