Trial record 3 of 4 for:    Open Studies | "Nonprescription Drugs"

Evaluation of Proposed EZ2go Complete Bowel Cleansing System

This study is currently recruiting participants.
Verified April 2013 by 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.
Information provided by (Responsible Party):
Borland-Groover Clinic Identifier:
First received: April 16, 2013
Last updated: April 23, 2013
Last verified: April 2013

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 Intervention
Screening Colonoscopy
Surveillance Colonoscopy
Other: Ez2go Complete
Other: LoSo Prep

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

Further study details as provided by Borland-Groover Clinic:

Primary Outcome Measures:
  • Measurement of Efficacy [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    The primary end point is efficacy of colonoscopy preparation measured by the Ottawa scale.

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

Estimated Enrollment: 168
Study Start Date: April 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its identifier: NCT01838408

Contact: Nancy Chaffin, CCRC 904-680-0871

United States, Florida
Borland-Groover Clinic Recruiting
Jacksonville, Florida, United States, 32256
Contact: Nancy Chaffin, CCRC    904-680-0871   
Principal Investigator: Michael Herman, DO         
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.
  More Information

Additional Information:
No publications provided

Responsible Party: Borland-Groover Clinic Identifier: NCT01838408     History of Changes
Other Study ID Numbers: Pro00008184
Study First Received: April 16, 2013
Last Updated: April 23, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Magnesium citrate
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 22, 2014