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

Study Overview
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Brief Summary
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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.

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

Conditions
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Colonoscopy

Intervention / Treatment
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* Drug: Golytely (polyethylene glycol)
* Drug: MiraLax (polyethylene glycol 3350)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: average risk screening for colon cancer Exclusion Criteria: subjects with a history of constipation

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Golytely<br>216 patients at random will provided a prescription for the standard 4 L golytely preparation as the bowel cleanser for their colonoscopy | Drug: Golytely (polyethylene glycol)<br>* 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.<br>|
| Experimental: MiraLax<br>216 patients will be randomized to take 238 gm of miralax mixed with 64 oz of gatorade for their bowel cleanser | Drug: MiraLax (polyethylene glycol 3350)<br>* 238 gm of MiraLax mixed in 64 oz of Gatorade, to be consumed in split dosing the day prior to scheduled colonoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bowel cleanliness as rated by the boston bowel prep survey |  | measured at the time of colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient tolerability |  | measured at check in to colonoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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efficacy of bowel cleansing, patient tolerability, Golytely, MiraLax, colonoscopy preparation, bowel preparation, screening colonoscopy