A Comparison of 5 Low Volume Bowel Preparations

Gastroenterology Services, Ltd.

Status and phase: Completed; Phase 4

Conditions: Bowel Preparation for Colonoscopy

Treatments: Drug: MiraLAX; Drug: SUPREP; Drug: MoviPrep; Other: Gatorade

Study type: Interventional

Funder types: Other

Identifiers

NCT01719653

1220121180

Details and patient eligibility

About

The purpose of this investigation is to compare 3 versions of MiraLAX/Gatorade, MoviPrep and SUPREP to see which preparation cleanses the colon best and which preparation is best tolerated.

Enrollment: 1,079 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients at least 18 years old planning to undergo an elective colonoscopy will be eligible for inclusion in our study. We would prefer to exclude as few groups as possible since in clinical practice these less well studied groups often need a colonoscopy and will need to have a colonoscopy preparation.

Exclusion criteria

1. Patients who are allergic (this is very rare) or intolerant to any of the study drugs.
2. Patients who are pregnant.
3. Patients who required multiple day colon preparations (2 days prior and 1 day prior) in the past will be excluded.
4. Patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon would not be considered elective colonoscopies and are excluded.
5. Patients with known renal disease (baseline creatinine greater than 1.50 mg/dl) will need to be excluded due to the magnesium in SUPREP which is contraindicated in patients with significant renal disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,079 participants in 5 patient groups

MiraLAX 306 g (Day-Prior)

Active Comparator group

Description:

MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM

Treatment:

Other: Gatorade

Drug: MiraLAX

MiraLAX 357 g (Day-Prior)

Experimental group

Description:

MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.

Treatment:

Other: Gatorade

Drug: MiraLAX

MiraLAX 306 g (Split-Dose)

Experimental group

Description:

MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.

Treatment:

Other: Gatorade

Drug: MiraLAX

MoviPrep (Split-Dose)

Active Comparator group

Description:

MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.

Treatment:

Drug: MoviPrep

SUPREP (Split-Dose)

Active Comparator group

Description:

SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.

Treatment:

Drug: SUPREP