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

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

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.

Study Overview

• Status: Completed
• Conditions: Preparation for Colonoscopy
• Intervention / Treatment: Drug: NuLytely; Drug: Gatorade/Miralax; Drug: Placebo; Drug: Bisacodyl

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Downers Grove, Illinois, United States, 60515
      • Gastroenterology Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nulytely; Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.	Drug: NuLytely; Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
Experimental: Gatorade/Miralax + 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.	Drug: Gatorade/Miralax; Gatorade 64 oz (1/2 gallon), Miralax 306 g to be consumed the day before your colonoscopy as follows: Miralax 51 g at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.; Drug: Placebo; Placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy
Experimental: Gatorade/Miralax + 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.	Drug: Gatorade/Miralax; Gatorade 64 oz (1/2 gallon), Miralax 306 g to be consumed the day before your colonoscopy as follows: Miralax 51 g at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.; Drug: Bisacodyl; Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy at 12 noon.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Ottawa scale measures colon cleanliness on a scale from 14 (very poor) to 0 (excellent).	After Colonoscopy

Collaborators and Investigators

• Sponsor: Gastroenterology Services, Ltd.
• Investigators: Principal Investigator: David P Gerard, M.D., Gastroenterology Services, Ltd.

Publications and helpful links

General Publications

• Gerard DP, Holden JL, Foster DB, Raiser MW. Randomized Trial of Gatorade/Polyethylene Glycol With or Without Bisacodyl and NuLYTELY for Colonoscopy Preparation. Clin Transl Gastroenterol. 2012 Jun 21;3(6):e16. doi: 10.1038/ctg.2012.11.

Helpful Links

• On line publication of study resulting from this work.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: February 3, 2010
• First Submitted That Met QC Criteria: February 4, 2010
• First Posted (Estimate): February 5, 2010

Study Record Updates

• Last Update Posted (Estimate): November 18, 2013
• Last Update Submitted That Met QC Criteria: November 15, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cathartics; Laxatives; Bisacodyl; Polyethylene glycol 3350
• Other Study ID Numbers: 1220100180