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

Colonoscopy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00889655
• Other study ID #: IRB00005072
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 28, 2009
• Last updated: April 28, 2009
• Start date: May 2009
• Est. completion date: May 2010

Study information

• Verified date: April 2009
• Source: Oregon Health and Science University
• Contact: Glenn Eisen, MD, MPH
• Phone: 503-494-8311
• Email: eiseng[@]ohsu.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 432
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

• average risk screening for colon cancer

Exclusion Criteria:

• subjects with a history of constipation

Study Design

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

Related Conditions & MeSH terms

• Colonoscopy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Oregon Health & Sciences University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bowel cleanliness as rated by the boston bowel prep survey		measured at the time of colonoscopy	No
Secondary	patient tolerability		measured at check in to colonoscopy	Yes