This study evaluates the efficacy, safety and tolerability of NER1006 versus a sodium picosulfate and magnesium salt solution (SP + MS) in adult patients requiring bowel cleansing prior to any procedure that requires a clean bowel, using a Day Before Only Dosing regimen. Approximately 484 patients will be randomised with the aim of achieving a minimum of 220 patients in each of the 2 groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Enrollment
515
The subject will self-administer both doses of NER1006 in the evening of Day 1 with 1-2 hours interval. Subject will take mandatory additional clear fluid after each dose.
The subject will self-administer SP+MS in the morning of Day 1 and afternoon of Day 1. Subject will take mandatory additional clear fluid after each dose.
Charité - Campus Virchow Klinikum
Berlin, Germany
University Hospital Schleswig-Holstein
Kiel, Germany
An der Germania Brauerei 6
Münster, Germany
An der Germania Brauerei 6
Milan, Italy
Osp.San Raffaele U.O. Gastroenterologia
Milan, Italy
P.T.P.Nuovo Regina Margherita
Rome, Italy
Onze Lieve Vrouwe Gashuis
Amsterdam, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, Netherlands
Radboud UMC
Nijmegen, Netherlands
Orbis Medisch Centrum
Sittard, Netherlands
...and 9 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 versus SP+MS was evaluated using a non-inferiority study design.
Time frame: One day (day before 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 versus SP+MS was evaluated using a non-inferiority study design.
Time frame: One day (day before colonoscopy)
Adenoma Detection Rate (Colon Ascendens)
Comparison of the number of patients with at least one adenoma detected in the colon ascendens when NER1006 is used for bowel cleansing versus SP+MS. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the colon ascendens.
Time frame: One day (day before colonoscopy).
Adenoma Detection Rate (Overall Colon)
Comparison of the number of patients with at least one adenoma detected in the overall colon when NER1006 is used for bowel cleansing versus SP+MS. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the overall colon.
Time frame: One day (day before colonoscopy)
Polyp Detection Rate (Colon Ascendens)
Comparison of the number of patients with at least one polyp detected in the colon ascendens when NER1006 is used for bowel cleansing versus SP+MS. Polyp detection rate (PDR) defined as the number of patients with at least one polyp in the colon ascendens.
Time frame: One day (day before 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 SP+MS. Polyp detection rate (PDR) defined as the number of patients with at least one polyp in the overall colon.
Time frame: One day (day before colonoscopy)
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