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

Oregon Health & Science University (OHSU)

Status and phase: Unknown; Phase 4

Conditions: Colonoscopy

Treatments: Drug: MiraLax (polyethylene glycol 3350); Drug: Golytely (polyethylene glycol)

Study type: Interventional

Funder types: Other

Identifiers

NCT00889655

IRB00005072

Details and patient eligibility

About

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.

Enrollment: 432 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• average risk screening for colon cancer

Exclusion criteria

• subjects with a history of constipation

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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432 participants in 2 patient groups

Golytely

Active Comparator group

Description:

216 patients at random will provided a prescription for the standard 4 L golytely preparation as the bowel cleanser for their colonoscopy

Treatment:

Drug: Golytely (polyethylene glycol)

MiraLax

Experimental group

Description:

216 patients will be randomized to take 238 gm of miralax mixed with 64 oz of gatorade for their bowel cleanser

Treatment:

Drug: MiraLax (polyethylene glycol 3350)