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

NCT00889655 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 432

Last updated 2009-04-29

No results posted yet for this study

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.

Conditions

  • Colonoscopy

Interventions

DRUG

Golytely (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.

DRUG

MiraLax (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.

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00889655 on ClinicalTrials.gov