NCT01714466已完成2 期
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
Norgine2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2012年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Stool weight output
研究概览
简要总结
A study to assess the pharmacodynamics, safety and tolerability of a PEG-based bowel cleansing solution (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
- 40 Years 至 70 Years（Adult, Older 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.
- •Subjects age 40 to 70 years.
- •Part B only: Subjects willing to undergoing a screening colonoscopy, where the subject:
- •is between 40 and 70 years of age and has a known personal or familial risk of colon neoplasia,or
- •is aged 55 to
- •Part A: 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.
- •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).
- •Willing, able and competent to complete the entire procedure and to comply with study instructions.
- •Ferrous sulphate should be stopped at least one week prior to study medication.
排除标准
- •Part A only: Subjects undergoing screening colonoscopy.
- •Presence of current clinically significant functional gastrointestinal (GI) disorder (e.g. gastric emptying disorder, chronic constipation, irritable bowel syndrome [IBS]).
- •Regular use of laxatives or colon motility altering drugs in the last month.
- •Donation or loss of 500 mL or more of blood within 8 weeks prior to the first dose of investigational drug.
- •Any history or current presence of ileus, gastrointestinal (GI) obstruction or perforation , GI tract cancer, inflammatory bowel disease (IBD) or colonic resection.
- •Known glucose-6-phosphatase dehydrogenase deficiency.
- •Known phenylketonuria.
- •History or evidence of any clinical significant cardiovascular or neurological disease, cardiac, renal or hepatic insufficiency.
- •Known hypersensitivity to polyethylene glycols and/or ascorbic acid.
- •History or evidence of any clinically relevant electrocardiogram (ECG) abnormalities and/or uncontrolled hypertension.
- •Evidence of dehydration.
- •Any evidence for clinically significant abnormal sodium or potassium levels or other clinically significant plasma electrolyte disturbances.
- •Females who are not post-menopausal with a positive pregnancy test. Females not using reliable methods of birth control if not post-menopausal.
- •Clinically relevant findings on physical examination based on the 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 months of study entry.
- •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.
- •Previous participation in the study.
- •Persons who are ordered to live in an institution on court or authority order
研究组 & 干预措施
Part A, arm 1
Experimental
Evening dose of TF048. Morning dose of TF043
干预措施: NER1006 (Drug)
Part A, arm 2
Experimental
Evening dose of TF043. Morning dose of TF048
干预措施: NER1006 (Drug)
Part A, arm 3
Experimental
Evening dose of TF047. Morning dose of TF043
干预措施: NER1006 (Drug)
Part A, arm 4
Active Comparator
MOVIPREP (Both evening and morning dose)
干预措施: MOVIPREP (Drug)
Part B, arm 1
Experimental
IMP selected based on the optimal dosing sequence and volume identified from Part A
干预措施: NER1006 (Drug)
Part B, arm 2
Experimental
IMP as used in Part B, arm 1, with a differing amount of additional clear fluid being consumed
干预措施: NER1006 (Drug)
Part B, arm 3
Active Comparator
IMP as used in Part B, arm 1, except for a reduced amount of ascorbate
干预措施: NER1006 (Drug)
Part B, arm 4
Experimental
MOVIPREP used in both evening and morning dose
干预措施: MOVIPREP (Drug)
结局指标
主要结局
Stool weight output
时间窗: 36 hours post-dose
Stool weight output generated by the IMP from the start of the intake on the evening of Day 1 and the following 24 hours
Cleansing success rate
时间窗: 36 hours post-dose
The cleansing success rate (grade A or B according to the Harefield Cleansing Scale)
次要结局
- Tolerability of medication (vomiting rate)(36 hours post-dose)
- EQ 5D patient questionnaire outcome (Part A only)(36 hours post-dose)
- Ascorbate concentration(36 hours post-dose)
- Cleansing scores for each colon segment(36 hours post-dose)
- Time and volume of IMP to reach a clear effluent(36 hours post-dose)
- Electrolytes concentration(36 hours post-dose)
- PEG3350 concentration(36 hours post-dose)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
4 期
Efficacy and Tolerability of PEG-only Laxative for Fecal Impaction and Chronic Constipation in ChildrenFaecal ImpactionConstipationNCT01592734Azienda Policlinico Umberto I96
已完成
3 期
A Safety and Efficacy Study of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing ColonoscopyColonoscopyNCT02819323Braintree Laboratories91
已完成
4 期
The Best Dosage and Timing of Polyethylene Glycol for Bowel Preparation Before Capsule EndoscopySmall Bowel DiseaseNCT02486536Zhizheng Ge410
已完成
3 期
Efficacy of Prokinetics With Split Dose of PEG in Morning Colonoscopic Bowel PreparationColonoscopyBowel PreparationNCT01513096Inje University152
Unknown
1 期
A Phase Ib Study With Pegylated Recombinant Human Endostatin in Advanced / Metastatic NSCLC or Other Solid TumorsSolid TumorNSCLCNCT04413227Jiangsu Simcere Pharmaceutical Co., Ltd.30