Safety and Tolerability Study of an Edible Colon Preparation

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02402270

Enrollment

Registered

2015-03-30

Start date

2015-05-31

Completion date

2016-06-30

Last updated

2018-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Preparation

Keywords

Colonoscopy, Preparation

Brief summary

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

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.

Interventions

DRUGNuLYTELY® (PEG 3350)

DRUGECP-019

DRUGMoviPrep® (PEG 3350)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 74 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
The proportion of patients with successful colon cleansing as assessed by the blinded gastroenterologists using the Aronchick Scale.	One year

Secondary

Measure	Time frame
Percentage of patients who completed each of the ECP-019 formulation/dosing regimens	One year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026