Safety and Tolerability Study of an Edible Colon Preparation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-06-30

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

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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.

Conditions

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Bowel Preparation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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ECP-019 A (Group A)

Group Type EXPERIMENTAL

ECP-019

Intervention Type DRUG

ECP-019 B (Group B)

Group Type EXPERIMENTAL

ECP-019

Intervention Type DRUG

ECP-019 C (Group C)

Group Type EXPERIMENTAL

ECP-019

Intervention Type DRUG

Group D

Group Type ACTIVE_COMPARATOR

MoviPrep® (PEG 3350)

Intervention Type DRUG

Group E

Group Type ACTIVE_COMPARATOR

NuLYTELY® (PEG 3350)

Intervention Type DRUG

Interventions

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NuLYTELY® (PEG 3350)

Intervention Type DRUG

ECP-019

Intervention Type DRUG

MoviPrep® (PEG 3350)

Intervention Type DRUG

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.