Safety and Tolerability Study of an Edible Colon Preparation
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|ClinicalTrials.gov Identifier: NCT02402270|
Recruitment Status : Completed
First Posted : March 30, 2015
Last Update Posted : January 29, 2018
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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
|Condition or disease||Intervention/treatment||Phase|
|Bowel Preparation||Drug: NuLYTELY® (PEG 3350) Drug: ECP-019 Drug: MoviPrep® (PEG 3350)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Actual Study Start Date :||May 2015|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
|Experimental: ECP-019 A (Group A)||
|Experimental: ECP-019 B (Group B)||
|Experimental: ECP-019 C (Group C)||
|Active Comparator: Group D||
Drug: MoviPrep® (PEG 3350)
|Active Comparator: Group E||
Drug: NuLYTELY® (PEG 3350)
- The proportion of patients with successful colon cleansing as assessed by the blinded gastroenterologists using the Aronchick Scale. [ Time Frame: One year ]
- Percentage of patients who completed each of the ECP-019 formulation/dosing regimens [ Time Frame: One year ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 74 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- Known intestinal stricture of any etiology.
- History of diabetes mellitus.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02402270
|United States, Indiana|
|Indianapolis, Indiana, United States, 46290|
|United States, New Hampshire|
|Lebanon, New Hampshire, United States, 03756|
|Responsible Party:||ColonaryConcepts LLC|
|Other Study ID Numbers:||
|First Posted:||March 30, 2015 Key Record Dates|
|Last Update Posted:||January 29, 2018|
|Last Verified:||January 2018|
Polyethylene glycol 3350