NCT02402270

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: ColonaryConcepts LLC · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bowel Preparation

Interventions

Type	Name	Description
DRUG	NuLYTELY® (PEG 3350)
DRUG	ECP-019
DRUG	MoviPrep® (PEG 3350)

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2015-03-30
• Last updated: 2018-01-29

Locations

2 sites across 1 country: United States