A Study Comparing PEG-3350 (Miralax) and Gatorade With PEG-ELS (Golytely) for Bowel Preparation Prior to Colonoscopy

Not Applicable

• Conditions: Bowel Preparation for Colonoscopy
• Interventions: Drug: Miralax mixed with Gatorade; Drug: PEG-ELS (Golytely); Drug: Miralax

• Registration Number: NCT01028573
• Lead Sponsor: Southern California Institute for Research and Education

Brief Summary

The purpose of this study to to see how well Miralax (PEG-3350) and Gatorade cleans the colon before a colonoscopy and how easy it is to take compared to Golytely (PEG-ELS) bowel preparation solution. Another purpose is to see if taking half of the bowel preparation solution on the evening before the colonoscopy and half on the morning of the colonoscopy will result in a cleaner colon than taking all of the bowel preparation solution on the evening before.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-12-07
• Study First Submitted QC: 2009-12-08
• Study First Posted: 2009-12-09
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-12
• Last Update Posted: 2012-03-14
• Primary Completion: 2012-07
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• 18-80 years in age
• Undergoing full colonoscopy for colorectal cancer screening or colon polyp/cancer surveillance or other diagnostic purpose

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Exclusion Criteria

• Allergic to polyethylene glycol
• Pregnant or lactating
• Baseline abnormalities of relevant serum electrolytes including Sodium, Potassium, Calcium, Magnesium and phosphorus
• Congestive Heart Failure NY Heart Assn, Grades III and IV
• Liver Cirrhosis Childs Pugh Class B or C
• Serum Creatinine greater than 1.5
• Previous alimentary tract surgery
• Ongoing symptoms of abdominal pain, bloating, nausea or constipation
• Ileus, suspected bowel obstruction, toxic colitis or megacolon, severe ulcerative colitis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3	Miralax mixed with Gatorade	238g of PEG-3350 mixed with 2L of Gatorade
Group 1	PEG-ELS (Golytely)	4L of PEG-ELS (Golytely) consumed on the evening before colonoscopy
Group 2	PEG-ELS (Golytely)	2L of PEG-ELS (Golytely) consumed on the evening before and 2L consumed on the morning of colonoscopy
Group 4	Miralax	1L of PEG-3350 + Gatorade

Primary Outcome Measures

Name	Time	Method
Quality of bowel prepreparation/cleanliness scored using the Boston Bowel Preparation Scale	two years

Trial Locations

Locations (1)

VA Long Beach Healthcare System; 🇺🇸 Long Beach, California, United States