Evaluation of a Mixed Bowel Prep (2L PEG + Bisacodyl) Versus PEG With Ascorbate

Study Overview
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Brief Summary
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It is hypothesized that PEG 2L with citrate and simeticone plus bisacodyl will have similar bowel cleansing efficacy versus PEG 2L with ascorbate. Safety, tolerability, acceptance and compliance of the two reduced volume PEG-based bowel preparation will be also compared.

Official Title
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Low Volume Bowel Preparation for Colonoscopy: a Comparison Between PEG-CS Plus Bisacodyl Versus PEG-ASC

Conditions
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Colonoscopy

Intervention / Treatment
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* Drug: 2L PEG-CS plus bisacodyl
* Drug: 2L PEG-ASC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Out-patients undergoing a complete colonoscopy Patient written informed consent Exclusion Criteria: Pregnant or lactating women or at a risk of becoming pregnant Hypersensitivity to any of the ingredients History of anaphylaxis to drugs or allergic reactions in general Known or suspected gastrointestinal obstruction or perforation Toxic megacolon; major colonic resection Heart failure (Class III or IV); severe renal failure; relevant diseases, that may interfere with the aim of the study Phenylketonuria;Glucose-6-phosphate dehydrogenase deficiency Unwillingness to co-operate and to comply with the requirements of the trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2L PEG-CS plus bisacodyl<br>Patients will be asked to take 2L PEG-CS plus bisacodyl (10-20 mg according to patient bowel habit) | Drug: 2L PEG-CS plus bisacodyl<br>* Patients will be asked to take 2L of Lovolesse and bisacodyl (10-20 mg according to patient bowel habit)<br>* Other names: Lovolesse 2L plus Lovoldyl 5 mg (2-4 tablets);|
| Active Comparator: 2L PEG-ASC<br>Patients will be asked to take PEG-ASC according to labeling instructions | Drug: 2L PEG-ASC<br>* Patients will asked to take PEG-ASC according to labeling instructions<br>* Other names: Moviprep;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the quality of bowel preparation by BBPS | BBPS is an established rating scale to evaluate the quality of bowel preparation. A score greater than 6 is considered as success. The rate of success will be compared between the two groups. | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in mucosal visibility between the two groups | Three point rating scale(0-2). | 20 minutes | 
| Number of patients with adverse events | Patient questioning. | 24 hours | 
| Difference in tolerability between the two groups | Difference in the percentage of patients in the two groups who developed GI symptoms related to bowel preparation. | 24 hours | 
| Difference in patients acceptability between the two groups | Difference in the percentage of patients in the two groups who were willing to repeat the preparation and easy to take the bowel preparation. | 24 hours | 
| Difference in patients compliance between the two groups | Difference in the percentage of patients who took at least 75% of bowel preparation. | 24 hours |