A Trial Comparing Bowel Preparation and Patient Tolerability of Miralax Versus Golytely
A Prospective, Randomized Controlled Trial Comparing the Efficacy and Patient Tolerability of MiraLAX (PEG 3350) vs Golytely as Bowel Preparation for Screening Colonoscopy
1 other identifier
interventional
432
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2009
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2009
CompletedFirst Posted
Study publicly available on registry
April 29, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedApril 29, 2009
April 1, 2009
1 year
April 28, 2009
April 28, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
bowel cleanliness as rated by the boston bowel prep survey
measured at the time of colonoscopy
Secondary Outcomes (1)
patient tolerability
measured at check in to colonoscopy
Study Arms (2)
Golytely
ACTIVE COMPARATOR216 patients at random will provided a prescription for the standard 4 L golytely preparation as the bowel cleanser for their colonoscopy
MiraLax
EXPERIMENTAL216 patients will be randomized to take 238 gm of miralax mixed with 64 oz of gatorade for their bowel cleanser
Interventions
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.
238 gm of MiraLax mixed in 64 oz of Gatorade, to be consumed in split dosing the day prior to scheduled colonoscopy.
Eligibility Criteria
You may qualify if:
- average risk screening for colon cancer
You may not qualify if:
- subjects with a history of constipation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oregon Health & Sciences University
Portland, Oregon, 97239, United States
Related Publications (1)
Enestvedt BK, Fennerty MB, Eisen GM. Randomised clinical trial: MiraLAX vs. Golytely - a controlled study of efficacy and patient tolerability in bowel preparation for colonoscopy. Aliment Pharmacol Ther. 2011 Jan;33(1):33-40. doi: 10.1111/j.1365-2036.2010.04493.x. Epub 2010 Oct 25.
PMID: 21083586DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 28, 2009
First Posted
April 29, 2009
Study Start
May 1, 2009
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
April 29, 2009
Record last verified: 2009-04