NCT00889655

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 432 (estimated)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2009-04-29
• Last updated: 2009-04-29

Locations

1 site across 1 country: United States