Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECP-019 A (Group A) | Experimental |
| |
| ECP-019 B (Group B) | Experimental |
| |
| ECP-019 C (Group C) | Experimental |
| |
| Group D | Active Comparator |
| |
| Group E | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NuLYTELY® (PEG 3350) | Drug |
| ||
| ECP-019 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with successful colon cleansing as assessed by the blinded gastroenterologists using the Aronchick Scale. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients who completed each of the ECP-019 formulation/dosing regimens | One year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indianapolis | Indiana | 46290 | United States | |||
Not provided
| ID | Term |
|---|---|
| C000595212 | polyethylene glycol 3350 |
| C520497 | MoviPrep |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| MoviPrep® (PEG 3350) | Drug |
|
| Lebanon |
| New Hampshire |
| 03756 |
| United States |