Safety and Tolerability Study of an Edible Colon Preparation
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 74 |
| Updated: | 1/31/2018 |
| Start Date: | May 2015 |
| End Date: | June 2016 |
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.
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
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
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.
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.
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.
We found this trial at
2
sites
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