A Study Comparing PEG-3350 (Miralax) and Gatorade With PEG-ELS (Golytely) for Bowel Preparation Prior to Colonoscopy

A Randomized, Controlled, Single-Blind Study Comparing the Efficacy, Tolerability and Safety of PEG-3350 (Miralax) and Gatorade With PEG-ELS (Golytely) for Bowel Preparation Prior to Colonoscopy

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01028573

Enrollment

400

Registered

2009-12-09

Start date

2009-11-30

Completion date

2012-07-31

Last updated

2012-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Preparation for Colonoscopy

Keywords

bowel preparation, colonoscopy

Brief summary

The purpose of this study to to see how well Miralax (PEG-3350) and Gatorade cleans the colon before a colonoscopy and how easy it is to take compared to Golytely (PEG-ELS) bowel preparation solution. Another purpose is to see if taking half of the bowel preparation solution on the evening before the colonoscopy and half on the morning of the colonoscopy will result in a cleaner colon than taking all of the bowel preparation solution on the evening before.

Interventions

DRUGPEG-ELS (Golytely)

4L consumed evening before colonoscopy

DRUGMiralax mixed with Gatorade

238g of PEG-3350 (Miralax) mixed with 2L of Gatorade consumed on the evening before colonoscopy

DRUGMiralax

1L of PEG-3350 + Gatorade consumed on the evening before and 1L of PEG-3350 + Gatorade consumed on the morning of Colonoscopy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* 18-80 years in age * Undergoing full colonoscopy for colorectal cancer screening or colon polyp/cancer surveillance or other diagnostic purpose

Exclusion criteria

* Allergic to polyethylene glycol * Pregnant or lactating * Baseline abnormalities of relevant serum electrolytes including Sodium, Potassium, Calcium, Magnesium and phosphorus * Congestive Heart Failure NY Heart Assn, Grades III and IV * Liver Cirrhosis Childs Pugh Class B or C * Serum Creatinine greater than 1.5 * Previous alimentary tract surgery * Ongoing symptoms of abdominal pain, bloating, nausea or constipation * Ileus, suspected bowel obstruction, toxic colitis or megacolon, severe ulcerative colitis

Design outcomes

Primary

Measure	Time frame
Quality of bowel prepreparation/cleanliness scored using the Boston Bowel Preparation Scale	two years

Countries

United States

Contacts

Primary ContactMazen Jamal, MD

mazen.jamal@va.gov(562) 826-5628

Backup ContactLea Liu

lea.liu@va.gov(562) 826-5058

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026