Phase 4
N=1,079
A Comparison of 5 Low Volume Bowel Preparations
Bowel Preparation for Colonoscopy
Bottom Line
View on ClinicalTrials.gov: NCT01719653 ↗Enrolled (actual)
1,079
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Chicago Bowel Preparation Scale — 33.54; 34.00; 34.67; 34.95 units on a scale — p=<0.005
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- MiraLAX (Drug); Gatorade (Other); MoviPrep (Drug); SUPREP (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gastroenterology Services, Ltd.
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Chicago Bowel Preparation Scale |
33.54; 34.00; 34.67; 34.95; 35.16; 31.82 | <0.005 sig |
| SECONDARY Boston Bowel Preparation Scale |
8.39; 8.57; 8.66; 8.80; 8.80 | <0.001 sig |
| SECONDARY Adequate/Inadequate Scale |
195; 196; 198; 197; 197; 5 | >0.005 |
Summary
The purpose of this investigation is to compare 3 versions of MiraLAX/Gatorade, MoviPrep and SUPREP to see which preparation cleanses the colon best and which preparation is best tolerated.
Eligibility Criteria
Inclusion Criteria
- Patients at least 18 years old planning to undergo an elective colonoscopy will be eligible for inclusion in our study. We would prefer to exclude as few groups as possible since in clinical practice these less well studied groups often need a colonoscopy and will need to have a colonoscopy preparation.
Exclusion Criteria
- Patients who are allergic (this is very rare) or intolerant to any of the study drugs.
- Patients who are pregnant.
- Patients who required multiple day colon preparations (2 days prior and 1 day prior) in the past will be excluded.
- Patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon would not be considered elective colonoscopies and are excluded.
- Patients with known renal disease (baseline creatinine greater than 1.50 mg/dl) will need to be excluded due to the magnesium in SUPREP which is contraindicated in patients with significant renal disease.
Data sourced from ClinicalTrials.gov (NCT01719653). 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.