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OpenTrials
Completed

NCT Number: NCT01063049

Gatorade/Miralax With or Without Bisacodyl Versus 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.

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Key information

Conditions

Preparation for Colonoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gastroenterology Services

Downers Grove, Illinois, 60515, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

Gatorade/Miralax

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.

NuLYTELY

Drug

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

Bisacodyl

Drug

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

Placebo

Drug

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

Primary outcomes

  1. The Quality of the Colon Preparation Will be Graded Using the Boston Bowel Preparation Scale

    Time frame: After Colonoscopy

    The Boston Bowel Preparation Scale measures cleanliness of the colon on a scale of 0 (very poor) to 9 (excellent).

Secondary outcomes

  1. 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

    Ottawa scale measures colon cleanliness on a scale from 14 (very poor) to 0 (excellent).

Sponsors and collaborators

Lead sponsor

Gastroenterology Services, Ltd.

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 5, 2010
Registry last updated
Nov 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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