Safety and Tolerability Study of an Edible Colon Preparation

ColonaryConcepts

Status and phase: Completed; Phase 2

Conditions: Bowel Preparation

Treatments: Drug: NuLYTELY® (PEG 3350); Drug: MoviPrep® (PEG 3350); Drug: ECP-019

Study type: Interventional

Funder types: Industry

Identifiers

NCT02402270

ECP-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 69 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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69 participants in 5 patient groups

ECP-019 A (Group A)

Experimental group

Treatment:

Drug: ECP-019

ECP-019 B (Group B)

Experimental group

Treatment:

Drug: ECP-019

ECP-019 C (Group C)

Experimental group

Treatment:

Drug: ECP-019

Group D

Active Comparator group

Treatment:

Drug: MoviPrep® (PEG 3350)

Group E

Active Comparator group

Treatment:

Drug: NuLYTELY® (PEG 3350)