Evaluation of Proposed EZ2go Complete Bowel Cleansing System
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
1 other identifier
interventional
185
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 16, 2013
CompletedFirst Posted
Study publicly available on registry
April 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedJanuary 27, 2015
January 1, 2015
1 year
April 16, 2013
January 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measurement of Efficacy
The primary end point is efficacy of colonoscopy preparation measured by the Ottawa scale.
24 hours
Secondary Outcomes (1)
Evaluate the safety
2 weeks
Study Arms (2)
EZ2go Complete
EXPERIMENTALEZ2go complete: Peg 3350, Magnesium Citrate and Simethicone
LoSo Prep ™
ACTIVE COMPARATORLoSo Prep ™: Magnesium citrate and Bisacodyl
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Borland-Groover Clinic
Jacksonville, Florida, 32256, United States
Related Links
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2013
First Posted
April 24, 2013
Study Start
April 1, 2013
Primary Completion
April 1, 2014
Study Completion
June 1, 2014
Last Updated
January 27, 2015
Record last verified: 2015-01