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
Sponsor:
Collaborator:
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
ClinicalTrials.gov Identifier:
NCT01838408
First received: April 16, 2013
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT01838408

Contacts
Contact: Nancy Chaffin, CCRC 904-680-0871 nchaffin01@bgclinic.com

Locations
United States, Florida
Borland-Groover Clinic Recruiting
Jacksonville, Florida, United States, 32256
Contact: Nancy Chaffin, CCRC    904-680-0871    nchaffin01@bgclinic.com   
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
ClinicalTrials.gov 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
colonoscopy

Additional relevant MeSH terms:
Magnesium citrate
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014