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Completed

NCT Number: NCT02402270

Safety and Tolerability Study of an Edible Colon Preparation

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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Key information

Conditions

Bowel Preparation

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Indianapolis, Indiana, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NuLYTELY® (PEG 3350)

Drug

ECP-019

Drug

MoviPrep® (PEG 3350)

Drug

Primary outcomes

  1. The proportion of patients with successful colon cleansing as assessed by the blinded gastroenterologists using the Aronchick Scale.

    Time frame: One year

Secondary outcomes

  1. Percentage of patients who completed each of the ECP-019 formulation/dosing regimens

    Time frame: One year

Sponsors and collaborators

Lead sponsor

ColonaryConcepts LLC

Industry

Registry information

Official study title

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.

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 30, 2015
Registry last updated
Jan 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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