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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Gerard, M.D., Gastroenterology Services, Ltd.
ClinicalTrials.gov Identifier:
NCT01063049
First received: February 3, 2010
Last updated: November 15, 2013
Last verified: November 2013
  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:


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


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


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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Publications:
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
Results First Received: August 20, 2013
Last Updated: November 15, 2013
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 August 21, 2014