Gatorade/Miralax With or Without Bisacodyl Versus NuLytely for Colonoscopy Preparation - Full Text View

Purpose

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.

Condition	Intervention	Phase
Preparation for Colonoscopy	Drug: Gatorade/Miralax Drug: NuLytely Drug: Bisacodyl Drug: Placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	Gatorade/Miralax With or Without Bisacodyl vs NuLytely for Colonoscopy Preparation

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy

Drug Information available for: Bisacodyl Trilyte Nulytely

U.S. FDA Resources

Further study details as provided by Gastroenterology Services, Ltd.:

Primary Outcome Measures:

The quality of the colon preparation will be graded using the Boston Bowel Preparation Scale [ Time Frame: After Colonoscopy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: After Colonoscopy ] [ Designated as safety issue: No ]
We will compare how well each preparation is tolerated using a patient question questionnaire [ Time Frame: Before Colonoscopy ] [ Designated as safety issue: No ]
We will compare how well each preparation was tolerated by checking a basic metabolic profile before the IV is started for the colonoscopy [ Time Frame: Before Colonoscopy ] [ Designated as safety issue: No ]
We will compare the quality of each preparation by asking the doctor "Did you consider the preparation adequate for a good quality colonoscopy?" [ Time Frame: After colonoscopy ] [ Designated as safety issue: No ]

Enrollment:	600
Study Start Date:	February 2010
Study Completion Date:	February 2011
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063049

Locations

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

Sponsors and Collaborators

Gastroenterology Services, Ltd.

Investigators

Principal Investigator:

David P Gerard, M.D.

Gastroenterology Services, Ltd.

More Information

Additional Information:

On line publication of study resulting from this work. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	David Gerard, M.D., MD, Gastroenterology Services, Ltd.
ClinicalTrials.gov Identifier:	NCT01063049 History of Changes
Other Study ID Numbers:	1220100180
Study First Received:	February 3, 2010
Last Updated:	August 29, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Bisacodyl
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013