A Prospective, Randomized Controlled Trial Comparing the Efficacy and Patient Tolerability of MiraLAX (PEG 3350) vs Golytely as Bowel Preparation for Screening Colonoscopy
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 432
- Locations
- 1
- Primary Endpoint
- bowel cleanliness as rated by the boston bowel prep survey
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 50 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •average risk screening for colon cancer
Exclusion Criteria
- •subjects with a history of constipation
Arms & Interventions
Golytely
216 patients at random will provided a prescription for the standard 4 L golytely preparation as the bowel cleanser for their colonoscopy
Intervention: Golytely (polyethylene glycol) (Drug)
MiraLax
216 patients will be randomized to take 238 gm of miralax mixed with 64 oz of gatorade for their bowel cleanser
Intervention: MiraLax (polyethylene glycol 3350) (Drug)
Outcomes
Primary Outcomes
bowel cleanliness as rated by the boston bowel prep survey
Time Frame: measured at the time of colonoscopy
Secondary Outcomes
- patient tolerability(measured at check in to colonoscopy)