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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-014845-95 | EudraCT Number |
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It is particularly important that thorough gut cleansing is achieved prior to the colonoscopy for the procedure to be successful. Polyethylene glycol plus electrolyte (PEG+E) solutions are well established as safe and effective agents for gut cleansing and Norgine has successfully developed a low volume (2 litre) PEG+E gut lavage solution. The efficacy and safety of this solution is similar to the standard 4 litre PEG+E, but with improved patient acceptance.
Tolerance, acceptability and satisfaction with the cleansing agent plays an important role in subjects' compliance with gut preparation procedure. The study medication NRL0706 is identical to the PEG+E-containing gut lavage solution commonly used in clinical practice, with the exception that the flavour has been modified from lemon to orange. This study is to investigate the tolerability, acceptability, safety and efficacy of a single dose of NRL0706 (MOVIPREP Orange) in subjects without gastrointestinal symptoms undergoing colonoscopy for colon cancer screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moviprep Orange | Experimental | All patients receive 2 litres of NRL0706 solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NRL0706 | Drug | Patients receive 1 litre of NRL0706 solution followed by 0.5 litre of clear liquid during the afternoon/evening prior to colonoscopy. Patients receive 1 litre of 0706 solution followed by 0.5 litre of clear liquid during the morning of colonoscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Acceptance on VAS (100mm) rating | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance on five-point VRS | 12 hours | |
| Taste Evaluation on VAS (100mm) rating | 12 hours | |
| Acceptability rated by compliance, four-point VRS and VAS (100mm) rating |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Fischbach, Prof Dr med | Klinikum Aschaffenburg-Alzenau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wolfgang Fischback | Aschaffenburg | D-63739 | Germany |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| 12 hours |
| Efficacy on five-grade scale for pre-defined colon areas | 12 hours |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |