Phase 4
N=600
Gatorade/Miralax With or Without Bisacodyl Versus NuLytely for Colonoscopy Preparation
Preparation for Colonoscopy
Bottom Line
View on ClinicalTrials.gov: NCT01063049 ↗Enrolled (actual)
600
Serious AEs
0.2%
Results posted
Nov 2013
Primary outcome: Primary: The Quality of the Colon Preparation Will be Graded Using the Boston Bowel Preparation Scale — 7.86; 8.05; 7.99 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Gatorade/Miralax (Drug); NuLytely (Drug); Bisacodyl (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gastroenterology Services, Ltd.
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Quality of the Colon Preparation Will be Graded Using the Boston Bowel Preparation Scale |
7.86; 8.05; 7.99 | — |
| SECONDARY 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 |
2.80; 2.58; 2.71 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01063049). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.