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

NCT ID: NCT01063049

Last Updated: 2013-11-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-02-28

Brief Summary

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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

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Conditions

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Preparation for Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Nulytely

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

Group Type ACTIVE_COMPARATOR

NuLytely

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Gatorade/Miralax

Intervention Type DRUG

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.

Placebo

Intervention Type DRUG

Placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy

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.

Group Type EXPERIMENTAL

Gatorade/Miralax

Intervention Type DRUG

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.

Bisacodyl

Intervention Type DRUG

Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy at 12 noon.

Interventions

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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.

Intervention Type DRUG

NuLytely

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

Intervention Type DRUG

Bisacodyl

Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy at 12 noon.

Intervention Type DRUG

Placebo

Placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gastroenterology Services, Ltd.

OTHER

Sponsor Role lead

Responsible Party

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David Gerard, M.D.

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David P Gerard, M.D.

Role: PRINCIPAL_INVESTIGATOR

Gastroenterology Services, Ltd.

Locations

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Gastroenterology Services

Downers Grove, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 23238266 (View on PubMed)

Related Links

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http://www.nature.com/ctg/journal/v3/n6/index.html

On line publication of study resulting from this work.

Other Identifiers

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1220100180

Identifier Type: -

Identifier Source: org_study_id