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
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