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

Information source: Oregon Health and Science University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colonoscopy

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

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Oregon Health and Science University

Overall contact:
Glenn Eisen, MD, MPH, Phone: 503-494-8311, Email: eiseng@ohsu.edu

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research

Primary outcome: bowel cleanliness as rated by the boston bowel prep survey

Secondary outcome: patient tolerability

Eligibility

Minimum age: 50 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- average risk screening for colon cancer

Exclusion Criteria:

- subjects with a history of constipation

Locations and Contacts

Glenn Eisen, MD, MPH, Phone: 503-494-8311, Email: eiseng@ohsu.edu

Oregon Health & Sciences University, Portland, Oregon 97239, United States; Not yet recruiting
Glenn Eisen, MD, MPH, Principal Investigator
Brintha Enestvedt, MD, MBA, Sub-Investigator
Brian M Fennerty, MD, Sub-Investigator
Jason E Williams, MD, MPH, Sub-Investigator
Additional Information

Starting date: May 2009
Last updated: April 28, 2009

Page last updated: August 23, 2015

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