Split Dose Golytely With Amitiza Pretreatment Versus Split Dose Golytely Plus Placebo in Outpatient Colonoscopy

Study Overview
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Brief Summary
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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.

Official Title
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Single Dose Lubiprostone Along With Split-dose PEG Solution Without Dietary Restrictions for Bowel Cleansing Prior to Colonoscopy, a Randomized, Double-blind, Placebo Controlled Trial

Conditions
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Bowel Preparation for Colonoscopy

Intervention / Treatment
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* Drug: lubiprostone
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment | Drug: lubiprostone<br>* lubiprostone 24mcg gelcap, 1 gelcap taken at noon the day prior to the colonoscopy<br>* Other names: amitiza;|
| Placebo Comparator: 2<br>split-dose PEG solution without dietary restrictions plus placebo pretreatment | Drug: placebo<br>* placebo gelcap, taken at noon the day prior to the colonoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Overall Cleanliness of the Prep as Measured by the Ottawa Scale | Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0-4), as well as a global 3-point rating for overall colonic fluid (0-2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0-3, a good preparation 4-6, while scores higher than 7would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of colonic fluid | measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction With the Prep Measured by 5 Point Likert Scale | The participants completed a survey prior to the colonoscopy that graded their overall satisfaction with the bowel preparation. The subjects rated the survey questions on a 5-point Likert scale where 1 = severely distressing, 2=distressing, 3=bothersome, 4=mild, and 5=none. | measured after completion of the bowel preparation and prior to the colonoscopy, completed during the course of the study (approximately 4 month period) | 
| Procedure Time | Procedure time refers to the total length of time required to complete the colonoscopy | measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period) | 
| The Number of Polyps Detected on Examination | The number of colon polyps detected during the colonoscopy. | measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period) |