Evaluation of Proposed EZ2go Complete Bowel Cleansing System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01838408
Recruitment Status : Completed
First Posted : April 24, 2013
Last Update Posted : January 27, 2015
Valley Medical Products, LLC is paying for the study and is the sponsor. The form would not go through with this listed.
Information provided by (Responsible Party):
Borland-Groover Clinic

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Screening Colonoscopy Surveillance Colonoscopy Colonoscopy Other: Ez2go Complete Other: LoSo Prep Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Official Title: Randomized, Single Blinded Study of Proposed EZ2go Complete Bowel Cleansing System: Evaluation of Its Safety, Efficacy and Patient Tolerance Compared to LOSO Prep, an Over the Counter Laxative Kit for Colonoscopy Bowel Preparation
Study Start Date : April 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: EZ2go Complete
EZ2go complete: Peg 3350, Magnesium Citrate and Simethicone
Other: Ez2go Complete
EZ2Go Complete

Active Comparator: LoSo Prep ™
LoSo Prep ™: Magnesium citrate and Bisacodyl
Other: LoSo Prep
LoSo Prep ™ Magnesium Citrate plus Bisacodyl Kit Study Arm

Primary Outcome Measures :
  1. Measurement of Efficacy [ Time Frame: 24 hours ]
    The primary end point is efficacy of colonoscopy preparation measured by the Ottawa scale.

Secondary Outcome Measures :
  1. Evaluate the safety [ Time Frame: 2 weeks ]
    A basic metabolic panel will be drawn at baseline and after the bowel preparation is complete to evaluate for any electrolyte and renal disturbances.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01838408

United States, Florida
Borland-Groover Clinic
Jacksonville, Florida, United States, 32256
Sponsors and Collaborators
Borland-Groover Clinic
Valley Medical Products, LLC is paying for the study and is the sponsor. The form would not go through with this listed.

Additional Information:
Responsible Party: Borland-Groover Clinic Identifier: NCT01838408     History of Changes
Other Study ID Numbers: Pro00008184
First Posted: April 24, 2013    Key Record Dates
Last Update Posted: January 27, 2015
Last Verified: January 2015

Keywords provided by Borland-Groover Clinic:
screening colonoscopy
surveillance colonoscopy

Additional relevant MeSH terms:
Magnesium citrate
Gastrointestinal Agents