Subjects without relevant clinical symptoms for gastrointestinal disorders will undergo a complete selective colonoscopy for colon cancer screening. MedDRA version: 12.0 Level: LLT Classification code 10010007 Term: Colonoscopy
Conditions
Interventions
Product Name: MOVIPREP Orange
Product Code: NRL0706
Pharmaceutical Form: Powder for oral solution
CAS Number: 0
Other descriptive name: MACROGOL 3350
Concentration unit: g gram(s)
Concentration type:
Sponsors
Norgine Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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. | — |
Countries
Germany
Outcome results
None listed