E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects without relevant clinical symptoms for gastrointestinal disorders will undergo a complete selective colonoscopy for colon cancer screening. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010007 |
E.1.2 | Term | Colonoscopy |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
Subjects’ VAS (100 mm) ratings for the overall tolerance of the intake of NRL0706 and the overall acceptance of the NRL0706 gut preparation. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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). |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |