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临床试验/NCT01714466
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:
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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
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

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

发起方
Norgine
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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