Phase 4
Completed N=425
A Trial Comparing Split-Dose Miralax With Amitiza Pretreatment Versus Dulcolax Pretreatment Versus Golytely for Bowel Cleansing Prior to Colonoscopy
Colonoscopy
Source: ClinicalTrials.gov NCT00953017 ↗
Enrolled (actual)
425
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcomePrimary: The Cleanliness of the Prep as Measured by the Ottawa Scale — 6.3; 6.8; 6.9; 5.1 Ottawa Scale
Summary
Miralax (PEG 3350) has been shown to be a safe and uncomplicated bowel preparation prior to colonoscopy in pediatric populations. This study seeks to confirm the efficacy of this bowel cleansing regimen in adults and to determine the benefit of adding a pretreatment medication to this bowel preparation. The tolerability of Miralax will hopefully improve patient satisfaction with colonoscopy and decrease their reluctance to be screened because of the uncomfortable taste and side effects of bowel preparation regimens.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Cleanliness of the Prep as Measured by the Ottawa Scale |
6.3; 6.8; 6.9; 5.1 | — |
| SECONDARY Patient Satisfaction With the Prep Measured by 5 Point Likert Scale |
3.8; 4.1; 4.0; 3.2 | — |
| SECONDARY Procedure Time |
21.3; 19.3; 20; 18.3 | — |
| SECONDARY Polyps Detected |
128; 92; 90; 101 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients referred to our clinic for average or increased risk screening for colorectal cancer
Exclusion Criteria
- elevated serum creatinine (Men >1.4mg/dL, Women >1.3mg/dL)
- previous diagnosis of congestive heart failure
- history of bowel obstruction
- history of solid organ transplant
- current pregnancy
- lactating mother
- participants allergic to either polyethylene glycol (Miralax), lubiprostone (Amitiza), or bisacodyl (Dulcolax)
Data sourced from ClinicalTrials.gov (NCT00953017). 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. Informational only — not medical advice.