Gatorade/Miralax With or Without Bisacodyl Versus NuLytely for Colonoscopy Preparation

Gastroenterology Services, Ltd.

Status and phase: Completed; Phase 4

Conditions: Preparation for Colonoscopy

Treatments: Drug: Placebo; Drug: Gatorade/Miralax; Drug: NuLytely; Drug: Bisacodyl

Study type: Interventional

Funder types: Other

Identifiers

NCT01063049

1220100180

Details and patient eligibility

About

The purpose of this study is to compare Nulytely (or Trilyte) with a Gatorade and Miralax combination for cleaning out the colon before colonoscopy. A laxative pill called Bisacodyl may also be used with the Gatorade and Miralax to see if it helps with the clean out process. We are trying to find out if either of these methods is more acceptable to the patient and does a better job cleaning out the colon for a colonoscopy.

Enrollment: 600 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients at least 18 years old planning to undergo an elective colonoscopy.

Exclusion criteria

1. Patients who are allergic or intolerant to any on the study drugs.
2. Pregnant patients.
3. Patients who required multiple day colon preparation in the past.
4. Patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon would not be considered elective colonoscopies and are excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 3 patient groups

Nulytely

Active Comparator group

Description:

Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.

Treatment:

Drug: NuLytely

Gatorade/Miralax + Placebo

Experimental group

Description:

Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.

Treatment:

Drug: Placebo

Drug: Gatorade/Miralax

Gatorade/Miralax + Bisacodyl

Experimental group

Description:

Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.

Treatment:

Drug: Gatorade/Miralax

Drug: Bisacodyl