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

Phase 4

Completed

• Conditions: Preparation for Colonoscopy
• Interventions: Drug: Gatorade/Miralax; Drug: NuLytely; Drug: Placebo; Drug: Bisacodyl

• Registration Number: NCT01063049
• Lead Sponsor: Gastroenterology Services, Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-03
• Study First Submitted QC: 2010-02-04
• Study First Posted: 2010-02-05
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Results First Submitted: 2013-08-20
• Status Verified: 2013-11
• Results First Submitted QC: 2013-11-15
• Last Update Submitted: 2013-11-15
• Results First Posted: 2013-11-18
• Last Update Posted: 2013-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gatorade/Miralax + Placebo	Gatorade/Miralax	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.
Gatorade/Miralax + Placebo	Placebo	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.
Gatorade/Miralax + Bisacodyl	Gatorade/Miralax	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.
Nulytely	NuLytely	Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
Gatorade/Miralax + Bisacodyl	Bisacodyl	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.

Primary Outcome Measures

Name	Time	Method
The Quality of the Colon Preparation Will be Graded Using the Boston Bowel Preparation Scale	After Colonoscopy	The Boston Bowel Preparation Scale measures cleanliness of the colon on a scale of 0 (very poor) to 9 (excellent).

Secondary Outcome Measures

Name	Time	Method
The Ottawa Scale for Colonoscopy Preparation Will be Reported and Compared Among the 3 Groups to Allow for Comparisons to Some of the Older Literature	After Colonoscopy	Ottawa scale measures colon cleanliness on a scale from 14 (very poor) to 0 (excellent).

Trial Locations

Locations (1)

Gastroenterology Services; 🇺🇸 Downers Grove, Illinois, United States