N/A
N=191
Split Dose Golytely With Amitiza Pretreatment Versus Split Dose Golytely Plus Placebo in Outpatient Colonoscopy
Bowel Preparation for Colonoscopy
Bottom Line
View on ClinicalTrials.gov: NCT00611442 ↗Enrolled (actual)
191
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcome: Primary: The Overall Cleanliness of the Prep as Measured by the Ottawa Scale — 4.8; 6.2 Ottawa Score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- lubiprostone (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brooke Army Medical Center
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Overall Cleanliness of the Prep as Measured by the Ottawa Scale |
4.8; 6.2 | — |
| SECONDARY Patient Satisfaction With the Prep Measured by 5 Point Likert Scale |
3.7; 3.2 | — |
| SECONDARY Procedure Time |
17.8; 19.8 | — |
| SECONDARY The Number of Polyps Detected on Examination |
48; 44 | — |
Summary
The primary outcomes of this procedure will be: 1. The cleanliness of the prep as measured by the Ottawa Scale (attachment a). Secondary outcomes will be: 1. Patient satisfaction with the prep measured by 5 point Likert scale (attachment b); 2. Procedure time; 3. The number and size of polyps detected on examination.
Eligibility Criteria
Inclusion Criteria
- Adult patients referred to our clinic for Average or Increased Risk screening for Colorectal Cancer
- Ages will be from 18 years of age and older
Exclusion Criteria
- Chronic kidney disease
- Previous diagnosis of congestive heart failure
- History of bowel obstruction
- History of solid organ transplant
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT00611442). 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.