Gatorade/Miralax With or Without Bisacodyl Versus NuLytely for Colonoscopy Preparation
1 other identifier
interventional
600
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 3, 2010
CompletedFirst Posted
Study publicly available on registry
February 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedResults Posted
Study results publicly available
November 18, 2013
CompletedNovember 18, 2013
November 1, 2013
1 year
February 3, 2010
August 20, 2013
November 15, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
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
After Colonoscopy
Study Arms (3)
Nulytely
ACTIVE COMPARATORNulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
Gatorade/Miralax + Placebo
EXPERIMENTALGatorade 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.
Gatorade/Miralax + Bisacodyl
EXPERIMENTALGatorade 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.
Interventions
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 (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy at 12 noon.
Placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy
Eligibility Criteria
You may qualify if:
- \. Patients at least 18 years old planning to undergo an elective colonoscopy.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gastroenterology Services
Downers Grove, Illinois, 60515, United States
Related 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(6):e16. doi: 10.1038/ctg.2012.11.
PMID: 23238266RESULT
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Both the BBPS and OPS suffer from poorly designed scoring systems that are not easily converted into the poor/fair/good/excellent subjective rating scale, which is often used by gastroenterologists in their colonoscopy reports.
Results Point of Contact
- Title
- Dr. David Gerard
- Organization
- Gastroenterology Services
Study Officials
- PRINCIPAL INVESTIGATOR
David P Gerard, M.D.
Gastroenterology Services, Ltd.
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
February 3, 2010
First Posted
February 5, 2010
Study Start
February 1, 2010
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
November 18, 2013
Results First Posted
November 18, 2013
Record last verified: 2013-11