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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Oregon Health and Science University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00889655
First received: April 28, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Colonoscopy
 Drug: Golytely (polyethylene glycol)
Drug: MiraLax (polyethylene glycol 3350)
 Phase 4

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

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • bowel cleanliness as rated by the boston bowel prep survey [ Time Frame: measured at the time of colonoscopy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • patient tolerability [ Time Frame: measured at check in to colonoscopy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 432
Study Start Date: May 2009
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Golytely
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)
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.
Experimental: MiraLax
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)
238 gm of MiraLax mixed in 64 oz of Gatorade, to be consumed in split dosing the day prior to scheduled colonoscopy.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • average risk screening for colon cancer

Exclusion Criteria:

  • subjects with a history of constipation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889655

Contacts
Contact: Glenn Eisen, MD, MPH 503-494-8311 eiseng@ohsu.edu
Contact: Brintha K Enestvedt, MD, MBA 503-494-8311 ext 11859 enestveb@ohsu.edu

Locations
United States, Oregon
Oregon Health & Sciences University Not yet recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Glenn Eisen, MD, MPH            
Sub-Investigator: Brintha Enestvedt, MD, MBA            
Sub-Investigator: Brian M Fennerty, MD            
Sub-Investigator: Jason E Williams, MD, MPH            
Sponsors and Collaborators
Oregon Health and Science University
  More Information

No publications provided by Oregon Health and Science University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Glenn Eisen, Oregon Health & Science University, Division of Gastroenterology
ClinicalTrials.gov Identifier: NCT00889655     History of Changes
Other Study ID Numbers: IRB00005072
Study First Received: April 28, 2009
Last Updated: April 28, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
efficacy of bowel cleansing
patient tolerability
Golytely
MiraLax
 colonoscopy preparation
bowel preparation
screening colonoscopy

ClinicalTrials.gov processed this record on May 21, 2013