Safety and Tolerability Study of an Edible Colon Preparation

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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An Adaptive, Single-Blind, Parallel, Randomized, Phase 2, Formulation Screening/Proof of Concept, Safety, Tolerability and Efficacy Study of Three Formulations/Dosing Regimens of ECP (PEG 3350) Colon Prep Kit Compared to Comparators.

Conditions
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Bowel Preparation

Intervention / Treatment
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* Drug: NuLYTELY® (PEG 3350)
* Drug: ECP-019
* Drug: MoviPrep® (PEG 3350)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients whose physician has prescribed colonoscopy for colorectal cancer screening or surveillance for colorectal cancer. Patients with a previous history of completing a bowel cleansing procedure for a colonoscopy. Exclusion Criteria: Known intestinal stricture of any etiology. History of diabetes mellitus.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ECP-019 A (Group A)<br> | Drug: ECP-019<br> <br> |
| Experimental: ECP-019 B (Group B)<br> | Drug: ECP-019<br> <br> |
| Experimental: ECP-019 C (Group C)<br> | Drug: ECP-019<br> <br> |
| Active Comparator: Group D<br> | Drug: MoviPrep® (PEG 3350)<br> <br> |
| Active Comparator: Group E<br> | Drug: NuLYTELY® (PEG 3350)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with successful colon cleansing as assessed by the blinded gastroenterologists using the Aronchick Scale. |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who completed each of the ECP-019 formulation/dosing regimens |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Preparation