A Study Comparing Picoprep With Mannitol and Bisacodyl for Colon Cleansing in Preparation for Colonoscopy

Study Overview
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Brief Summary
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This is a randomized, controlled, parallel group, assessor-blinded study to compare two colon cleansing preparations for colonoscopy. Subjects meeting all inclusion and exclusion criteria will be randomized and assigned to one of two study groups: Group I (PicoPrep) or Group II (Mannitol). In Group I, subjects will take one sachet of PicoPrep on the day before colonoscopy, and another sachet on the day of colonoscopy. In Group II, subjects will take Bisacodyl on the day before colonoscopy, and Mannitol on the day of colonoscopy.

Official Title
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A Randomized, Controlled, Parallel Group, Assessor-Blinded Study To Compare The Efficacy, Tolerability, And Safety Of Oral Sodium Picosulfate (PicoPrep®) Versus Oral Mannitol and Bisacodyl, For Colon Cleansing In Colonoscopy Preparation Of Adult Outpatients

Conditions
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Bowel Preparation

Intervention / Treatment
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* Drug: sodium picosulfate, magnesium oxide and citric acid (Picoprep®)
* Drug: mannitol
* Drug: Bisacodyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women aged 18 to 60 years Subjects scheduled for an elective colonoscopy Women of child-bearing potential using at least one highly effective contraceptive method Subjects able to understand all instructions Informed consent signed Exclusion Criteria: Hypersensitivity to active ingredients Female participants pregnant or with a positive blood pregnancy test Acute surgical abdomen Previous colorectal surgery Gastrointestinal (GI) surgery GI diseases, active inflammatory bowel disease, colon disease Ascites/hepatic cirrhosis, cardiac disease, advanced pulmonary or renal disease Use of laxatives or antidiarrheal agents 72 hours prior to screening Significant alterations in laboratory values or other diseases that could interfere with the results

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Picoprep<br>sodium picosulfate, magnesium oxide and citric acid | Drug: sodium picosulfate, magnesium oxide and citric acid (Picoprep®)<br> <br> |
| Active Comparator: Mannitol and Bisacodyl<br> | Drug: mannitol<br> <br> Drug: Bisacodyl<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects classified as success (Aronchick scale) | Defined as excellent or good according to the Aronchick scale | At visit 2 (day 1 of colonoscopy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects classified as success (Ottawa scale) | Defined as excellent, good or fair according to the Ottawa scale | At visit 2 (day 1 of colonoscopy) | 
| Aggregate Tolerability Score (Colonoscopy Preparation Subject Tolerability Questionnaire) | As assessed by a Colonoscopy Preparation Subject Tolerability Questionnaire | At visit 2 (day 1 of colonoscopy) | 
| Subject satisfaction (Likert scale) | As assessed by a subject survey using a 3 point Likert scale | At visit 2 (day 1 of colonoscopy) |