A Comparison of 5 Low Volume Bowel Preparations

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1079 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Bowel Preparation for Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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MiraLAX 306 g (Day-Prior)

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

Group Type ACTIVE_COMPARATOR

MiraLAX

Intervention Type DRUG

MiraLAX consumed as described in each arm.

Gatorade

Intervention Type OTHER

Gatorade consumed as described in each arm.

MiraLAX 357 g (Day-Prior)

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.

Group Type EXPERIMENTAL

MiraLAX

Intervention Type DRUG

MiraLAX consumed as described in each arm.

Gatorade

Intervention Type OTHER

Gatorade consumed as described in each arm.

MiraLAX 306 g (Split-Dose)

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.

Group Type EXPERIMENTAL

MiraLAX

Intervention Type DRUG

MiraLAX consumed as described in each arm.

Gatorade

Intervention Type OTHER

Gatorade consumed as described in each arm.

MoviPrep (Split-Dose)

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.

Group Type ACTIVE_COMPARATOR

MoviPrep

Intervention Type DRUG

MoviPrep consumed as described in each arm.

SUPREP (Split-Dose)

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.

Group Type ACTIVE_COMPARATOR

SUPREP

Intervention Type DRUG

SUPREP consumed as described in each arm.

Interventions

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MiraLAX

MiraLAX consumed as described in each arm.

Intervention Type DRUG

Gatorade

Gatorade consumed as described in each arm.

Intervention Type OTHER

MoviPrep

MoviPrep consumed as described in each arm.

Intervention Type DRUG

SUPREP

SUPREP consumed as described in each arm.

Intervention Type DRUG

Other Intervention Names

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PEG-3350

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes