EUCTR2012-003052-37-DE进行中（未招募）不适用
Pharmacodynamic and clinical evaluation of dose and taste-optimised low volume PEG-based bowel cleansing solutions using the split-dosing intake regimen in healthy subjects and in subjects undergoing screening colonoscopy - OPT Study
orgine Ltd0 个研究点开始时间: 2012年8月9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
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
- •(1) The subject’s written informed consent must be obtained prior to inclusion.
- •(2) Subjects age 40 to 70 years.
- •(3) Part B only: Subjects willing to undergo screening colonoscopy, where the subject:
- •(a) is between 40 and 70 years of age and has a known personal or familial risk of colon neoplasia, or
- •(b) is aged 55 to 70.
- •(4) Part A only: Subjects need to be without any history of clinically significant gastrointestinal symptoms by clinical judgement and without the presence of acute abdominal discomfort or symptoms.
- •(5) Females of child bearing potential must be surgically sterile, post-menopausal, practicing true sexual abstinence or using an acceptable form of effective contraception throughout the study from the following list: contraceptive injections, implants, oral contraceptives, intrauterine system (IUS), some intrauterine devices (IUDs), vasectomised partner or barrier method (condom or occlusive cap) with spermicidal foam/gel/film/cream/suppository. Females using oral contraceptives must also use additional contraception. Hormonal and IUD methods of contraception must be established for a period of 3 months prior to dosing and cannot be changed or altered during the study. All females must have a negative pregnancy test at screening and check-in (unless post-menopausal).
- •(6) Willing, able and competent to complete the entire procedure and to comply with study instructions.
- •(7) Ferrous sulphate should be stopped at least one week prior to study medication.
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •(1) Part A only: Subjects undergoing screening colonoscopy.
- •(2) Presence of current clinically significant functional gastrointestinal disorder (e.g. gastric emptying disorder, chronic constipation, irritable bowel syndrome [IBS]).
- •(3) Regular use of laxatives or colon motility altering drugs in the last month.
- •(4) Donation or loss of 500 mL or more of blood within 8 weeks prior to the first dose of investigational drug.
- •(5) Any history or current presence of ileus, gastrointestinal (GI) obstruction or perforation, GI tract cancer, inflammatory bowel disease (IBD) or colonic resection.
- •(6) Known glucose-6-phosphatase dehydrogenase deficiency.
- •(7) Known phenylketonuria.
- •(8) History or evidence of any clinical significant cardiovascular or neurological disease, cardiac, renal or hepatic insufficiency.
- •(9) Known hypersensitivity to polyethylene glycols and/or ascorbic acid.
- •(10) History or evidence of any clinically relevant electrocardiogram (ECG) abnormalities and/or uncontrolled hypertension.
- •(11) Evidence of dehydration.
- •(12) Any evidence for clinically significant abnormal sodium or potassium levels or other clinically significant plasma electrolyte disturbances.
- •(13) Females who are not post-menopausal with a positive pregnancy test. Females not using reliable methods of birth control if not post-menopausal.
- •(14) Clinically relevant findings on physical examination based on the Investigator’s judgement.
- •(15) Clinically relevant deviations of laboratory parameters from reference ranges at screening or check-in evaluation.
- •(16) Positive serology for chronic viral hepatitis or human immunodeficiency virus (HIV) at screening.
- •(17) History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or check-in evaluations.
- •(18) Subjects who are unwilling to comply with the provisions of the study protocol.
- •(19) Concurrent participation in an investigational drug study or participation within 3 months of study entry.
- •(20) Subject has a condition or is in a situation, which in the Investigator’s opinion may put the subject at significant risk, may confound the study results, or may interfere significantly.
- •(21) Previous participation in the study.
- •(22) Persons who are ordered to live in an institution on court or authority order.
研究者
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