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

Southern California Institute for Research and Education

Status: Unknown

Conditions: Bowel Preparation for Colonoscopy

Treatments: Drug: Miralax; Drug: PEG-ELS (Golytely); Drug: Miralax mixed with Gatorade

Study type: Interventional

Funder types: Other

Identifiers

NCT01028573

976

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 4 patient groups

Group 1

Active Comparator group

Description:

4L of PEG-ELS (Golytely) consumed on the evening before colonoscopy

Treatment:

Drug: PEG-ELS (Golytely)

Drug: PEG-ELS (Golytely)

Group 2

Experimental group

Description:

2L of PEG-ELS (Golytely) consumed on the evening before and 2L consumed on the morning of colonoscopy

Treatment:

Drug: PEG-ELS (Golytely)

Drug: PEG-ELS (Golytely)

Group 3

Experimental group

Description:

238g of PEG-3350 mixed with 2L of Gatorade

Treatment:

Drug: Miralax mixed with Gatorade

Group 4

Experimental group

Description:

1L of PEG-3350 + Gatorade

Treatment:

Drug: Miralax