Safety and Tolerability Study of an Edible Colon Preparation

Phase 2

Completed

• Conditions: Bowel Preparation
• Interventions: Drug: ECP-019; Drug: MoviPrep® (PEG 3350); Drug: NuLYTELY® (PEG 3350)

• Registration Number: NCT02402270
• Lead Sponsor: ColonaryConcepts LLC

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.

Study Timeline

• Study First Submitted: 2015-03-25
• Study First Submitted QC: 2015-03-27
• Study First Posted: 2015-03-30
• Study Start: 2015-05
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2018-01
• Disposition First Submitted: 2018-01-26
• Disposition First Submitted QC: 2018-01-26
• Last Update Submitted: 2018-01-26
• Disposition First Posted: 2018-01-29
• Last Update Posted: 2018-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ECP-019 B (Group B)	ECP-019	-
ECP-019 A (Group A)	ECP-019	-
ECP-019 C (Group C)	ECP-019	-
Group D	MoviPrep® (PEG 3350)	-
Group E	NuLYTELY® (PEG 3350)	-

Primary Outcome Measures

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

Secondary Outcome Measures

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