Open study to assess the tolerability, safety and efficacy of an adapted 2 litre gut cleansing solution (NRL0706) in routine colon cleansing prior to colonoscopies for colon tumour screening

orgine Ltd.0 个研究点开始时间: 2009年11月5日最近更新: 2012年11月19日

适应症

试验速览

暂无简介。

•1. The subject's written informed consent must be obtained prior to inclusion.
•2. Male or female ambulatory subjects aged between 40 to 75 years undergoing a
•complete colonoscopy for colon cancer screening.
•3. No history of significant gastrointestinal diseases, including gastrointestinal
•obstruction and perforation or acute symptoms requiring a colonoscopy procedure.
•4. Willing to undergo a colonoscopy for colon cancer screening.
•5. Willing, able and competent to complete the entire procedure and to comply
•with study instructions.
•6. Females of childbearing potential must employ an adequate method of contraception.
•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

•1. History of gastric emptying disorders
•2. History of ileus, toxic megacolon, gastrointestinal obstruction and colonic perforation
•3. History of Phenylketonuria
•4. Known Glucose-6-phosphate dehydrogenase deficiency
•5. Known hypersensitivity to macrogol 3350, sodium sulphate or ascorbic acid/
•sodium ascorbate
•6. History of colonic resection
•7. Requirement for permanent medication and associated stable serum concentrations (e.g. neuroleptic drugs)
•8. Presence of congestive heart failure (NYHA III + IV)
•9. Acute life-threatening cardiovascular disease
•10. Documented history of severe renal insufficiency
•11. Application of any unlicensed medication within the previous 3 months or
•participation in any other research study in the last 3 months
•12. Females who are pregnant, nursing or planning a pregnancy. Females of child
•bearing potential not using reliable methods of contraception
•13. Subjects who the investigator feels would not be compliant with the requirements of the trial
•Each investigator will be supplied with a Non-Evaluable-Subject-Log. The investigator
•will record every subject asked to participate in the study and the reasons for not
•enrolling the subject (e.g. refusal of the subject, exclusion criteria).

发起方

orgine Ltd.