A Trial Comparing Bowel Preparation and Patient Tolerability of Miralax Versus Golytely

A Prospective, Randomized Controlled Trial Comparing the Efficacy and Patient Tolerability of MiraLAX (PEG 3350) vs Golytely as Bowel Preparation for Screening Colonoscopy

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00889655

Enrollment

432

Registered

2009-04-29

Start date

2009-05-31

Completion date

2010-05-31

Last updated

2009-04-29

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

Conditions

Colonoscopy

Keywords

efficacy of bowel cleansing, patient tolerability, Golytely, MiraLax, colonoscopy preparation, bowel preparation, screening colonoscopy

Brief summary

Prior to colonoscopies, the colon is cleansed using a laxative. Golytely is approved by the FDA for this purpose. Another laxative, called MiraLax, is approved by the FDA to relieve constipation, but it is not approved specifically for preparation for a colonoscopy. Nonetheless, it is commonly used in clinical practice for this purpose, just as is Golytely. The purpose of this study is to compare Golytely and MiraLax in two ways: to see whether one is better tolerated by patients than the other and to see whether one more effectively cleanses the bowel than the other. The investigators' hypothesis is that these 2 bowel preparation methods are equally effective in bowel cleansing, but that patients prefer Miralax to Golytely.

Interventions

DRUGGolytely (polyethylene glycol)

4 L of golytely, in split dosing. If the patient has a morning colonoscopy, they will take 2 L of golytely over 2 hours the morning prior to their procedure and repeat this at 6 pm the night prior to their procedure.

DRUGMiraLax (polyethylene glycol 3350)

238 gm of MiraLax mixed in 64 oz of Gatorade, to be consumed in split dosing the day prior to scheduled colonoscopy.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to 90 Years

Healthy volunteers

Yes

Inclusion criteria

* average risk screening for colon cancer

Exclusion criteria

* subjects with a history of constipation

Design outcomes

Primary

Measure	Time frame
bowel cleanliness as rated by the boston bowel prep survey	measured at the time of colonoscopy

Secondary

Measure	Time frame
patient tolerability	measured at check in to colonoscopy

Countries

United States

Contacts

Primary ContactGlenn Eisen, MD, MPH

eiseng@ohsu.edu503-494-8311

Backup ContactBrintha K Enestvedt, MD, MBA

enestveb@ohsu.edu503-494-8311

Outcome results

None listed

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