Miralax (PEG 3350) vs. Golytely as Bowel Preparation for Screening Colonoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Frank K. Friedenberg, Temple University
ClinicalTrials.gov Identifier:
NCT01170754
First received: July 22, 2010
Last updated: May 6, 2016
Last verified: May 2016
  Purpose

A major limitation to the widespread acceptance of colonoscopy as a procedure to screen for colorectal cancer is the laxative preparation. Phosphate-based preps (e.g. Fleets Phosphosoda) are now used on a limited basis because of their known association with renal injury. Polyethylene glycol (PEG) mixed with a balanced electrolyte solution (e.g. Golytely) has been used for over two decades for colon cleansing. The mixture is not very palatable due to the electrolyte additives which include sodium sulfate.

To overcome the limitation of existing preps, gastroenterologists and colorectal surgeons worldwide have been using PEG powder alone (same quantity as found in Golytely prep) not mixed with electrolytes (Glycolax or Miralax) and dissolving this into 64 ounces of Gatorade. Conservatively, we estimate that 25% of colonoscopies in the US are being done with this prep. Anecdotally there have been reports (case series) that it is far more palatable and the prep is equally efficacious. The active ingredient, PEG, is not changed and therefore this is not surprising. The issue at present is that there has never been a blinded study to confirm these claims.

This study will compare the efficacy of the two preps. There is no funding. The investigators will charge insurance companies for the prep - this is our current practice. The procedures will be done on healthy individuals referred for colon cancer screening and the exam will be billed to their insurance. There will be no patient honorarium. The investigators will check electrolytes to be sure patients do not develop hypokalemia with the Gatorade prep.


Condition Intervention Phase
Colon Cancer
Drug: PEG-3350 and Gatorade
Drug: Golytely 4 liters
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Controlled Trial Comparing the Efficacy and Patient Tolerability of Miralax (PEG 3350) vs. Golytely as Bowel Preparation for Screening Colonoscopy

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • Comparison of the Efficacy, of the Standard Bowel Preparation Golytely With Miralax. [ Time Frame: photographs were taken throughout the colonoscopy and reviewed within 1 month after procedure. ] [ Designated as safety issue: No ]

    The study is a non-inferiority study: The objective is to conclude that the prep quality scores of those receiving Miralax is at most 10% less than for Golytely. Thus the difference in prep scores between Miralax minus Golytely should be greater than - 10%. If this is the case, Miralax would be considered as non-inferior to Golytely.

    The outcome measure will use the Boston Prep Scale. The BPS is scored 0-9 with 9 being an excellent preparation throughout the colon. From the right colon, transverse colon , and left colon a score of 0-3 is given as follows and the total BPS is the arithmetic sum from each colon segment:

    0 = Unprepared colon segment with mucosa not seen due to solid stool.

    1. = Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen.
    2. = Minor amount of residual staining, small fragments of stool and/or opaque liquid
    3. = clear colon without staining


Secondary Outcome Measures:
  • Safety of Two Competing PEG Preparations [ Time Frame: please refer to adverse events table for description ] [ Designated as safety issue: Yes ]
    Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.


Enrollment: 136
Study Start Date: April 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEG-3350 and Gatorade
255 miralax with 64 oz gatorade.
Drug: PEG-3350 and Gatorade
255 grams of miralax mixed with 64 ounces gatorade for colonoscopy preparation.
Other Name: nulytely, PEG-3350, Miralax, glycolax
Active Comparator: Golytely 4 Liters
Golytely 4 Liters
Drug: Golytely 4 liters
Golytely 4 liters
Other Name: polyethylene glycol/electrolytes

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  Eligibility

Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All adults undergoing average risk colon cancer screening (ages 40-75 years old)

•Able to provide informed consent

Exclusion Criteria:

  • A history of constipation
  • Patients who use medications to assist with a bowel movement such as osmotic, stimulant, or cathartic laxatives (including "colon cleansers")
  • Diabetes or glucose intolerance
  • Patients with severe underlying renal or hepatic impairment
  • Pregnant women - pregnancy test performed on all menstruating women before procedure.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01170754

Locations
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
Investigators
Principal Investigator: Frank Friedenberg, MD Temple University
  More Information

Publications:
Responsible Party: Frank K. Friedenberg, Professor of Medicine, Temple University
ClinicalTrials.gov Identifier: NCT01170754     History of Changes
Other Study ID Numbers: PEG-3350 
Study First Received: July 22, 2010
Results First Received: April 16, 2015
Last Updated: May 6, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Temple University:
PEG-3350, polyethylene glycol, colonoscopy

Additional relevant MeSH terms:
Polyethylene glycol 3350
Laxatives
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 21, 2016