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Laxative

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

Phase 4
Waitlist Available
Led By Frank Friedenberg, MD
Research Sponsored by Temple University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up photographs were taken throughout colonoscopy and reviewed within 1 month after procedure
Awards & highlights
Approved for 5 Other Conditions
Pivotal Trial
No Placebo-Only Group
All Individual Drugs Already Approved
Drug Has Already Been Approved

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.

Eligible Conditions
  • Colon Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~photographs were taken throughout the colonoscopy and reviewed within 1 month after procedure.
This trial's timeline: 3 weeks for screening, Varies for treatment, and photographs were taken throughout the colonoscopy and reviewed within 1 month after procedure. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Boston Prep Scale
Secondary study objectives
BUN Level in mg/dl
Bicarbonate Level in mmol/L
Calcium Level in mg/dl
+7 more
Other study objectives
Boston Prep Scale (Per Protocol Analysis)

Side effects data

From 2011 Phase 4 trial • 136 Patients • NCT01170754
6%
Hypokalemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
PEG-3350 and Gatorade
Golytely 4 Liters

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PEG-3350 and GatoradeExperimental Treatment1 Intervention
255 miralax with 64 oz gatorade.
Group II: Golytely 4 LitersActive Control1 Intervention
Golytely 4 Liters
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Potassium chloride
FDA approved

Find a Location

Who is running the clinical trial?

Temple UniversityLead Sponsor
316 Previous Clinical Trials
89,118 Total Patients Enrolled
Frank Friedenberg, MDPrincipal InvestigatorTemple University
1 Previous Clinical Trials
~9 spots leftby Dec 2025