Evaluation of Proposed EZ2go Complete Bowel Cleansing System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-06-30

Brief Summary

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This study aims to provide safety and efficacy data comparable to available over-the-counter bowel preparations prior to colonoscopy. While there are many bowel preparations available, most of them remain expensive and require prescription from a health provider. The investigators believe EZ2go Complete will provide a non-inferior colon cleansing in a more accessible way (over-the-counter).

To accomplish this goal, the investigators decided to evaluate the proposed EZ2go combination versus currently available over-the-counter bowel preparations. The investigators believe the EZ2go kit will not be inferior to current FDA approved over-the-counter bowel preparations.

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Detailed Description

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Conditions

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Screening Colonoscopy Surveillance Colonoscopy Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Investigators

Study Groups

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EZ2go Complete

EZ2go complete: Peg 3350, Magnesium Citrate and Simethicone

Group Type EXPERIMENTAL

Ez2go Complete

Intervention Type OTHER

EZ2Go Complete

LoSo Prep ™

LoSo Prep ™: Magnesium citrate and Bisacodyl

Group Type ACTIVE_COMPARATOR

LoSo Prep

Intervention Type OTHER

LoSo Prep ™ Magnesium Citrate plus Bisacodyl Kit Study Arm

Interventions

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Ez2go Complete

EZ2Go Complete

Intervention Type OTHER

LoSo Prep

LoSo Prep ™ Magnesium Citrate plus Bisacodyl Kit Study Arm

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients referred for routine colorectal cancer screening or surveillance colonoscopy examinations.
* Male and Female participants 18 years of age and older.
* Female participants who are not pregnant or planning to become pregnant within the next 90 days, or are sterile or of non-childbearing potential.
* Negative urine test at the screening visit.
* Subject is able to read and understand the informed consent form and signs the informed consent form.

Exclusion Criteria

* Contraindication to any of the bowel preparations being used in the study.
* Unable/unwilling to fill out patient questionnaires following procedure.
* Pregnant or lactating.
* Unwilling to perform indicated lab work.
* Lab results that would indicate stage 4-5 chronic kidney disease (GFR \<30MI/min1.73 m2).
* Personal history of colorectal cancer.
* Personal history of colorectal or small bowel surgery.
* Participants have any condition that, in the investigators opinion, could interfere with the participation and completion of this study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes