NCT01834742已完成1 期
Pharmacodynamic Evaluation of Stool Output Following Oral Administration of Various Low Volume PEG3350-based Gut Cleansing Solutions Using the Split Dose Intake in Healthy Subjects
Norgine1 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Primary Variable
研究概览
简要总结
This study is to investigate the effect of various modified low volume polyethylene glycol (PEG) 3350 and ascorbic acid/ascorbate (PEG+ASC)-based gut cleansing solutions on stool output in healthy subjects. In addition, the study is to assess and compare the safety and tolerance of the modified PEG+ASC formulations following oral administration with the safety profile of MOVIPREP®.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject's written informed consent must be obtained prior to inclusion.
- •Healthy subjects with an age of 18 to 45 years.
- •Healthy subjects need to be without any history of clinical significant gastrointestinal symptoms by clinical judgement and without the presence of acute abdominal discomfort or symptoms.
- •Females must be surgically sterile, practicing true sexual abstinence or using an acceptable form of effective contraception throughout the study from the following list: contraceptive implants, injectables, 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. 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.
- •Willing, able and competent to complete the entire procedure and to comply with study instructions.
排除标准
- •Use of laxatives in the last 12 months or colon motility altering drugs in the last 6 months.
- •Use of any prescription or over-the-counter (OTC) medication within 4 weeks prior to the first dose of investigational drug (excluding hormonal contraception, and occasional use of nonsteroidal anti-inflammatory drugs [NSAID], acetaminophen or metamizole).
- •Donation or loss of 500 mL or more of blood within 8 weeks prior to the first dose of investigational drug.
- •Any evidence of the history or presence of organic or functional gastrointestinal conditions (e.g. chronic constipation, irritable bowel syndrome [IBS], inflammatory bowel disease [IBD]).
- •Exhibiting relevant abnormal gastrointestinal motility according to clinical judgement in the past or now.
- •History or presence of any clinically significant acute illness within the 4 weeks prior to the first dose of investigational drug based on clinical judgement at screening and check-in evaluation.
- •Known glucose-6-phosphatase dehydrogenase deficiency.
- •Known phenylketonuria.
- •History or evidence of any clinical significant systemic cardiovascular, hepatic, pulmonal, neurological, metabolic and/or renal organ dysfunction.
- •History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis), known hypersensitivity to polyethylene glycols and/or ascorbic acid.
- •History or evidence of any clinically relevant electrocardiogram (ECG) abnormalities and hypertension.
- •Evidence of dehydration.
- •Any evidence for abnormal sodium or potassium levels or clinically significant other electrolyte disturbances.
- •Females who are pregnant, having a positive pregnancy test at screening and/or admission to unit or planning a pregnancy. Females not using reliable methods of birth control.
- •Clinically relevant findings on physical examination based on Investigator's judgement.
- •Clinically relevant deviations of laboratory parameters from reference ranges at screening or check-in evaluation.
- •Positive serology for chronic viral hepatitis or human immunodeficiency virus (HIV) at screening.
- •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.
- •Subjects who are unwilling to comply with the provisions of the study protocol.
- •Concurrent participation in an investigational drug study or participation within 3 month of study entry.
- •Subject has a condition or is in a situation, which in the Investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly.
- •Previous participation in the study.
研究组 & 干预措施
Part A, arm 1
Experimental
Evening dose 1 plus fixed morning dose
干预措施: NER1006 (Drug)
Part A, arm 2
Experimental
Evening dose 2 plus fixed morninf does
干预措施: NER1006 (Drug)
Part A, arm 3
Experimental
Evening dose 3 plus fixed morning dose
干预措施: NER1006 (Drug)
Part A, arm 4
Active Comparator
Moviprep
干预措施: Moviprep (Drug)
Part B, arm 1
Experimental
Fixed evening dose plus morning dose 1
干预措施: NER1006 (Drug)
Part B, arm 2
Experimental
Fixed evening dose plus morning dose 2
干预措施: NER1006 (Drug)
Part B, arm 3
Experimental
Fixed evening dose plus morning dose 3
干预措施: NER1006 (Drug)
Part B, arm 4
Experimental
Fixed evening dose plus alternative morning dose
干预措施: NER1006 (Drug)
结局指标
主要结局
Primary Variable
时间窗: 36 Hours
Stool weight output generated from the start of intake for the following 24 hours.
次要结局
- PEG3350 concentration(96 Hours)
- Sulphate concentration(96 hours)
- Ascorbic acid concentration(96 hours)
- Electrolytes concentration(96 hours)
- Safety profile(96 hours)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Comparator Study of PEG 3350 Versus Prucalopride in Females With Chronic ConstipationConstipationNCT01251822Norgine240
已完成
4 期
Extended Use of Polyethyleneglycol3350 Laxative in Constipated PatientsConstipationNCT00153153Braintree Laboratories300
尚未招募
不适用
The Efficacy and Palatability of Developed Polyethylene Glycol-based Formula for Children With Functional ConstipationFunctional ConstipationNCT06357897Chulalongkorn University52
招募中
3 期
Comparison of the effect of Polyethylene Glycol (Single dose vs divided dose) in Treatment of Functional Constipation in ChildreConstipation.K59.0ConstipationIRCT20090908002434N9Shiraz University of Medical Sciences80
终止
2 期
Polyethylene Glycol Interferon Alfa-2b (PEG Intron) Versus Interferon Alfa-2b (INTRON^® A) in the Treatment of Newly Diagnosed Chronic Myelogenous Leukemia (CML) (C98026)Chronic Myelogenous LeukemiaNCT03547154Merck Sharp & Dohme LLC344