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NCT02402270 Clinical Trial

Safety and Tolerability Study of an Edible Colon Preparation

Bowel Preparation Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02402270
Other study ID # ECP-002
Secondary ID
Status Completed
Phase Phase 2
First received March 25, 2015
Last updated January 26, 2018
Start date May 2015
Est. completion date June 2016

Study information
Verified date January 2018
Source ColonaryConcepts LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 69
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 74 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• NuLYTELY® (PEG 3350)

• ECP-019

• MoviPrep® (PEG 3350)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
ColonaryConcepts LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The proportion of patients with successful colon cleansing as assessed by the blinded gastroenterologists using the Aronchick Scale. One year
Secondary Percentage of patients who completed each of the ECP-019 formulation/dosing regimens One year
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