This study evaluates the efficacy, safety and tolerability of NER1006 versus MOVIPREP in adult patients requiring bowel cleansing prior to any procedure that requires a clean bowel, using a 2-Day evening/morning Split-Dosing and 1-Day morning only Split-Dosing regimens. Approximately 810 patients will be randomised with the aim of achieving a minimum of 245 patients in each of the 3 groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Enrollment
849
The subject will self-administer the first dose of the assigned investigational product in the evening prior to the scheduled colonoscopy and take mandatory additional clear fluid. Subject will take the second dose together with mandatory additional clear fluids on the morning of the colonoscopy.
The subject will self-administer the first dose of the investigational product on the morning of the colonoscopy and take mandatory additional clear fluid. After a 1-2 hour break the subject will self-administer the second dose plus additional clear mandatory fluid.
The subject will self-administer the first dose of the assigned investigational product in the evening prior to the scheduled colonoscopy and take recommended additional clear fluid. Subject will take the second dose together with recommended additional clear fluids on the morning of the colonoscopy.
AZ Sint-Lucas
Bruges, Belgium
UZ Ghent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
CHC- Clinique Saint-Joseph
Liège, Belgium
Hôpital Avicenne- Service de Gastro-Entérologie
Bobigny, France
Hôpital Hotel-Dieu
Nantes, France
Kliniken Essen-Mitte; Abteilung für Gastroenterologie
Essen, Germany
Klinikum der Friedrich Schiller Universität Jena
Jena, Germany
Praxis für Innere Medizin, Gastroenterologie und Allg. Medizin
Ludwigshafen, Germany
A.O.U. di Bologna - Policlinico S. Orsola-Malpighi
Bologna, Italy
...and 19 more locations
Number of Patients With Successful Bowel Cleansing (Overall Colon)
The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). A final HCS grading of A, B, C or D was derived. Grades A and B are classified as successful (i.e. all mucosa could be visualized) and C and D are classified as unsuccessful. Comparison of overall success of cleansing with NER1006 2-Day and 1-Day versus MOVIPREP was evaluated using a non-inferiority study design.
Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)
Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)
The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). Highly effective cleansing in the colon ascendens corresponded to scores 3 (Good) or 4 (Excellent) of the HCS. Adequate plus failure of cleansing corresponded to score 0-2. Comparison of 'Excellent plus good' cleansing of the colon ascendens using NER1006 2-Day and 1-Day versus MOVIPREP was evaluated using a non-inferiority study design.
Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)
Adenoma Detection Rate (Colon Ascendens)
Comparison of the number of patients with at least one adenoma detected in the colon ascendens when NER1006 2-Day and 1-Day is used for bowel cleansing versus MOVIPREP. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the colon ascendens.
Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)
Adenoma Detection Rate (Overall Colon)
Comparison of the number of patients with at least one adenoma detected in the overall colon when NER1006 2-Day and 1-Day is used for bowel cleansing versus MOVIPREP. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the overall colon.
Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)
Polyp Detection Rate (Colon Ascendens)
Comparison of the number of patients with at least one polyp detected in the colon ascendens when NER1006 2-Day and 1-Day is used for bowel cleansing versus MOVIPREP. Polyp detection rate (PDR) defined as the number of patients with at least one polyp in the colon ascendens.
Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)
Polyp Detection Rate (Overall Colon)
Comparison of the number of patients with at least one polyp detected in the overall colon when NER1006 is used for bowel cleansing versus number detected when MOVIPREP is used. PDR defined as the number of patients with at least one polyp in the overall colon.
Time frame: Up to 2 days (from day of first dosing to day of colonoscopy)
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