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

• Conditions: MedDRA version: 12.0Level: LLTClassification code 10010007Term: Colonoscopy; Subjects without relevant clinical symptoms for gastrointestinal disorders will undergo a complete selective colonoscopy for colon cancer screening.

• Registration Number: EUCTR2009-014845-95-DE
• Lead Sponsor: orgine Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-05
• Last Update Posted: 19 November 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the tolerability, acceptability, safety and efficacy of the flavour modified 2 litre gut cleansing solution (NRL0706; tradename: MOVIPREP ORANGE) in routine colon cleansing prior to screening colonoscopies.;Secondary Objective: Subjects’ VAS (100 mm) ratings for the overall tolerance of the intake of NRL0706<br>and the overall acceptance of the NRL0706 gut preparation.;Primary end point(s): Subject’s Visual Analogue Scale (VAS (100 mm)) ratings for the overall tolerance of the intake of NRL0706 and the overall acceptance of the NRL0706 gut preparation.