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

Preparation for Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01063049
• Other study ID #: 1220100180
• Status: Completed
• Phase: Phase 4
• First received: February 3, 2010
• Last updated: November 15, 2013
• Start date: February 2010
• Est. completion date: February 2011

Study information

• Verified date: November 2013
• Source: Gastroenterology Services, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Preparation for Colonoscopy

Intervention

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.
• NuLytely
Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
• Bisacodyl
Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy at 12 noon.
• Placebo
Placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy

Locations

Country	Name	City	State
United States	Gastroenterology Services	Downers Grove	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Gastroenterology Services, Ltd.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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:e16. doi: 10.1038/ctg.2012.11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No

External Links

•   On line publication of study resulting from this work.