The purpose of this study is to learn about a new bowel preparation that uses food to clean the colon. In order to learn about this new food preparation, some people in this study will get the food preparation, and others will get the standard liquid bowel preparation. Patients will be randomized (like flipping a coin) to one of five groups: Group 1 - Menu A Meal Kit - contains bars, shakes, soup, and a rice bowl Group 2 - Menu B Meal Kit - contains bars, shakes, soup, and a rice bowl Group 3 - Menu C Meal Kit - contains bars and shakes Group 4 - MoviPrep Group 5 - NuLYTELY
The purpose of this Phase 2 formulation screening/proof of concept study is to evaluate the safety, tolerability, and efficacy of up to 3 ECP-019 formulations/dosing regimens comprising a PEG 3350 Colon Prep Kit, containing electrolytes provided by the foods, in 3 formulations/ dosing regimens as compared to 2 comparators in a Phase 2 study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
69
Unnamed facility
Indianapolis, Indiana, United States
Unnamed facility
Lebanon, New Hampshire, United States
The proportion of patients with successful colon cleansing as assessed by the blinded gastroenterologists using the Aronchick Scale.
Time frame: One year
Percentage of patients who completed each of the ECP-019 formulation/dosing regimens
Time frame: One year
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