NCT02402270

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

January 29, 2018

Status Verified

January 1, 2018

Enrollment Period

1.1 years

First QC Date

March 25, 2015

Last Update Submit

January 26, 2018

Conditions

Bowel Preparation

Keywords

ColonoscopyPreparation

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients with successful colon cleansing as assessed by the blinded gastroenterologists using the Aronchick Scale.

    One year

Secondary Outcomes (1)

  • Percentage of patients who completed each of the ECP-019 formulation/dosing regimens

    One year

Study Arms (5)

ECP-019 A (Group A)

EXPERIMENTAL
Drug: ECP-019

ECP-019 B (Group B)

EXPERIMENTAL
Drug: ECP-019

ECP-019 C (Group C)

EXPERIMENTAL
Drug: ECP-019

Group D

ACTIVE COMPARATOR
Drug: MoviPrep® (PEG 3350)

Group E

ACTIVE COMPARATOR
Drug: NuLYTELY® (PEG 3350)

Interventions

NuLYTELY® (PEG 3350)DRUG
Group E
ECP-019DRUG
ECP-019 A (Group A)ECP-019 B (Group B)ECP-019 C (Group C)
MoviPrep® (PEG 3350)DRUG
Group D

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Known intestinal stricture of any etiology.
  • History of diabetes mellitus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Indianapolis, Indiana, 46290, United States

Location

Unknown Facility

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Interventions

polyethylene glycol 3350MoviPrep

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2015

First Posted

March 30, 2015

Study Start

May 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

January 29, 2018

Record last verified: 2018-01

Locations

US(2)