To compare the efficacy, acceptability and safety of the new 2 liter gut cleansing solution (Moviprep) and NaP preparation in routine colon cleansing prior to tumor screening colonoscopies
This was a randomized and multicenter phase III study in ambulatory subjects undergoing an elective colonoscopy for colon cancer screening. Gut cleansing was performed using either the 2 liters of Moviprep gut lavage solution or the 90 ml NaP-containing preparation prior to colonoscopy. Efficacy, acceptability and safety assessments was performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
360
2L gut lavage solution
45 ml solution; BID
Klinikum Aschaffenburg Am Hasenkopf 1
Aschaffenburg, Bavaria, Germany
Schiessgrabenstr. 34
Augsburg, Bavaria, Germany
Spardorfer Str. 39
Erlangen, Bavaria, Germany
Efficacy was measured as the degree of cleansing using a 5 grades scale for each of the predefined colon areas resulting into a final grading of the overall quality of gut preparation (A or B: "success" versus C or D: "failure").
the "overall" judgment of the investigator for the colon preparation was documented.
Subject satisfaction/acceptance with the gut lavage procedure was recorded on a VAS scale ranging from 0 to 100 mm.
The taste of the solutions was assessed.
Acceptability and tolerance for the subject was compared.
All Adverse Events were recorded to evaluate the safety.
Laboratory tests (such as blood chemistry and hematology) were conducted to support the safety data as well as measurement of body weight, blood pressure and pulse rate, but also tolerance.
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Heiligengrabstr. 22
Hof, Bavaria, Germany
Rätestr. 20
Kirchheim, Bavaria, Germany
Sternbergstr. 8
Regensburg, Bavaria, Germany
Israelitische Krankenhaus Abt. innere Medizin Orchideenstieg 14
Hamburg, Hamburg, Germany
Dieburger Str. 29
Darmstadt, Hesse, Germany
Unter den Eichen 26
Oldenburg, Lower Saxony, Germany
Erzbergstr. 113
Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
...and 2 more locations