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

NCT01170754 | Completed Phase 4 Results

• 1 other identifier: PEG-3350
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colon Cancer

Keywords

PEG-3350, polyethylene glycol, colonoscopy

Outcome Measures

Primary Outcomes (1)

• Boston Prep Scale

  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

  photographs were taken throughout the colonoscopy and reviewed within 1 month after procedure.

Secondary Outcomes (10)

• Sodium Level in mmol/L

  Day of procedure

• Potassium Level in mmol/L

  Day of procedure

• Chloride Level in mmol/L

  Day of procedure

• Bicarbonate Level in mmol/L

  Day of procedure

• BUN Level in mg/dl

  Day of procedure

Other Outcomes (1)

• Boston Prep Scale (Per Protocol Analysis)

  photographs were taken throughout colonoscopy and reviewed within 1 month after procedure

Study Arms (2)

PEG-3350 and Gatorade

EXPERIMENTAL

255 miralax with 64 oz gatorade.

Drug: PEG-3350 and Gatorade

Golytely 4 Liters

ACTIVE COMPARATOR

Golytely 4 Liters

Drug: Golytely 4 liters

Interventions

PEG-3350 and Gatorade DRUG

255 grams of miralax mixed with 64 ounces gatorade for colonoscopy preparation.

Also known as: nulytely, PEG-3350, Miralax, glycolax

PEG-3350 and Gatorade

Golytely 4 liters DRUG

Golytely 4 liters

Also known as: polyethylene glycol/electrolytes

Golytely 4 Liters

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adults undergoing average risk colon cancer screening (ages 40-75 years old)
• Able to provide informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (1)

• McKenna T, Macgill A, Porat G, Friedenberg FK. Colonoscopy preparation: polyethylene glycol with Gatorade is as safe and efficacious as four liters of polyethylene glycol with balanced electrolytes. Dig Dis Sci. 2012 Dec;57(12):3098-105. doi: 10.1007/s10620-012-2266-5. Epub 2012 Jun 19.

  PMID: 22711499 RESULT

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

polyethylene glycol 3350; gatorade; Polyethylene Glycols; Electrolytes

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Inorganic Chemicals

Results Point of Contact

• Title: Frank Friedenberg, MD
• Organization: Temple University

frank.friedenberg@temple.edu

215-707-9900

Study Officials

• Frank Friedenberg, MD

  Temple University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2010
• First Posted: July 27, 2010
• Study Start: April 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 13, 2017
• Results First Posted: June 14, 2016

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)