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

April 28, 2009
April 28, 2009
May 2009
May 2010   (final data collection date for primary outcome measure)
bowel cleanliness as rated by the boston bowel prep survey [ Time Frame: measured at the time of colonoscopy ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
patient tolerability [ Time Frame: measured at check in to colonoscopy ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
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.
  • 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.
  • 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
    Intervention: Drug: Golytely (polyethylene glycol)
  • Experimental: MiraLax
    216 patients will be randomized to take 238 gm of miralax mixed with 64 oz of gatorade for their bowel cleanser
    Intervention: Drug: MiraLax (polyethylene glycol 3350)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
432
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • average risk screening for colon cancer

Exclusion Criteria:

  • subjects with a history of constipation
Both
50 Years to 90 Years
Yes
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
United States
 
NCT00889655
IRB00005072
Yes
Glenn Eisen, Oregon Health & Science University, Division of Gastroenterology
Oregon Health and Science University
Not Provided
Not Provided
Oregon Health and Science University
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP